Knee Osteoarthritis
Conditions
Keywords
Osteoarthritis, Knee Osteoarthritis
Brief summary
The purpose of this study is to examine the effectiveness of standard physical therapy and an internet-based exercise program for people with knee osteoarthritis (OA). Both of these programs will be compared to a waiting list control group. The investigators hypothesize that both treatments will result in greater improvement than the control condition and that the treatments will be similarly effective. The investigators also expect that some patients may do better with one treatment type or another and will explore this.
Interventions
BEHAVIORALInternet Based Exercise Training
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
BEHAVIORALPhysical Therapy
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
Sponsors
Patient-Centered Outcomes Research Institute
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Knee Osteoarthritis
Exclusion criteria
* no internet access * rheumatoid arthritis, lupus, or any other rheumatic condition * severe fibromyalgia * gout in your knees * on a waiting list for joint replacement surgery, or are you planning to have joint replacement surgery during the next year * total knee replacement surgery, other knee surgery, a torn meniscus in your knee, or a torn ACL in your knee during the past 6 months * hospitalized for a stroke, heart attack, heart failure, or had surgery for blocked arteries in the past 3 months * currently undergoing physical therapy for knee OA * meeting current recommendations for physical activity levels * participating in another interventional study related to knee osteoarthritis or a study that involves physical activity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score | baseline, 4 months, and 12 months | Change over time in the primary outcome measure for this study, the WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). The scale ranges from 0-96 with higher scores indicating worse symptoms and function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test | baseline, 4 months, and 12 months | One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the 2 minute step test, the minimum is 0 steps and there is no maximum scale score (participants complete as many steps as they can in 2 minutes); greater steps indicate better function. |
| Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time | baseline, 4 months, and 12 months | One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the unilateral stand test, scores scan range from 0-10 seconds, with higher time indicating better balance. |
| Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand | baseline, 4 months, and 12 months | One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the 30 second chair stand test, the minimum is 0 stands and there is no maximum scale score (participants complete as many stands as they can in 30 seconds; greater numbers of stands indicate better function. |
| Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go | baseline, 4 months, and 12 months | One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the timed up and go, there are no minimum or maximum scores (participants complete the task as quickly as they are able); shorter (lower) times indicate better function. |
| Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8 | baseline, 4 months, and 12 months | Depressive symptoms and severity will be assessed using the PHQ-8, a reliable and valid measure of depression71. The PHQ-8 is an eight-item survey derived from the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic tool, and consists of items corresponding to the depression criteria listed in the Diagnostic and Statistics Manual Fourth Edition (DSM-IV). Each of the eight questions is scored as 0 (not at all) to 3 (nearly every day), so that total scores range from 0 to 24, with higher scores indicating more depressive symptoms. |
| Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale | baseline, 4 months, and 12 months | This is a validated, 5-item questionnaire that assesses patients' satisfaction with their ability to complete basic functional tasks that are often affected by lower extremity OA, including stair-climbing, walking, doing housework (light and heavy, and lifting and carrying). All 5 items are rated on a 7 point scale ranging from Very Dissatisfied (-3) Very Satisfied (+3). The total scale ranges from -15 to +15,with higher scores indicating greater satisfaction with function. |
| Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument | baseline, 4 months, and 12 months | The PROMIS adult sleep related impairment item bank focuses on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. It assesses sleep-related impairment over the past seven days. This scale includes 8 items, each measured on a 5-point Likert scale. Per PROMIS scoring instructions, raw scores are converted into standardized t-scores with a mean of 50 and standard deviation of 10. T-scores can range from 30.5-77.6; higher scores indicate worse sleep impairment. |
| Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument | baseline, 4 months, and 12 months | The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. It assesses fatigue over the past seven days, This scale includes 8 items, each measured on a 5-point Likert scale. Per PROMIS scoring instructions, raw scores are converted into standardized t-scores with a mean of 50 and standard deviation of 10. T-scores can range from 33.1-77.8; higher scores indicate worse fatigue. |
| Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale | baseline, 4 months, and 12 months | The Brief Fear of Movement Scale is a six item scale for assessing fear of movement in OA. The scale specifically assesses activity avoidance due to pain-related fear of movement. All items are measured on a 4-point scale from strongly agree to strongly disagree. The score ranges from 0-24 with higher scores indicating more fear of movement. |
| Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE) | baseline, 4 months, and 12 months | The Physical Activity Scale for the Elderly (PASE) is a self-report, 12-item scale that measures level occupational, household, and leisure activity during a one-week period. This scale was particularly developed for use among older adults; although all participants in the proposed study will not be age 65 or over, patients with knee OA typically have more limited physical activity than the general population. Therefore we believe this scale will be more applicable to our participant group than scales that were developed for younger adults. The typical range for the total PASE score is 0-400, with higher scores indicating greater activity. |
| Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | baseline, 4 months, and 12 months | Number of minutes per week, on average, they are completing strengthening, stretching, and aerobic exercises. The minimum score is 0, and there is no maximum score; higher scores indicate more weekly activity. |
| Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | baseline, 4 months, and 12 months | The KOOS is a patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. Five KOOS subscale scores were administered: Pain (9 items), Function in daily living (17 items), Function in Sport and Recreation (5 items), and knee-related Quality of Life (4 items). All items are scored on 5-point Likert scales. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Physical Therapy Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises. | 140 |
| Internet Based Exercise Training Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content. | 142 |
| Wait List Control no intervention | 68 |
| Total | 350 |
Baseline characteristics
| Characteristic | Wait List Control | Standard Physical Therapy | Internet Based Exercise Training | Total |
|---|---|---|---|---|
| Age, Continuous | 64.3 years STANDARD_DEVIATION 12.2 | 65.7 years STANDARD_DEVIATION 10.3 | 65.3 years STANDARD_DEVIATION 11.5 | 65.3 years STANDARD_DEVIATION 11.1 |
| Bachelors Degree or More Education | 42 Participants | 86 Participants | 80 Participants | 208 Participants |
| Body Mass Index | 30.1 kg/m2 STANDARD_DEVIATION 7.3 | 31.9 kg/m2 STANDARD_DEVIATION 8.6 | 31.5 kg/m2 STANDARD_DEVIATION 7.8 | 31.4 kg/m2 STANDARD_DEVIATION 8 |
| Employed | 31 Participants | 59 Participants | 51 Participants | 141 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 67 Participants | 134 Participants | 138 Participants | 339 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Fair or Poor Self-Reported Health | 12 Participants | 14 Participants | 22 Participants | 48 Participants |
| Low Income Financial Status | 13 Participants | 20 Participants | 29 Participants | 62 Participants |
| Married or Living with Partner | 42 Participants | 80 Participants | 93 Participants | 215 Participants |
| Number of Joints with Arthritis Symptoms | 5.5 joints STANDARD_DEVIATION 3.9 | 5.5 joints STANDARD_DEVIATION 3 | 5.2 joints STANDARD_DEVIATION 3.1 | 5.4 joints STANDARD_DEVIATION 3.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 8 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 24 Participants | 33 Participants | 70 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) White | 49 Participants | 109 Participants | 94 Participants | 252 Participants |
| Self-reported Years with Arthritis Symptoms | 14.2 years STANDARD_DEVIATION 13 | 14.1 years STANDARD_DEVIATION 11.6 | 11.6 years STANDARD_DEVIATION 11 | 13.1 years STANDARD_DEVIATION 11.7 |
| Sex: Female, Male Female | 15 Participants | 40 Participants | 44 Participants | 99 Participants |
| Sex: Female, Male Male | 53 Participants | 100 Participants | 98 Participants | 251 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 140 | 2 / 142 | 0 / 68 |
| other Total, other adverse events | 0 / 140 | 0 / 142 | 0 / 68 |
| serious Total, serious adverse events | 8 / 140 | 12 / 142 | 9 / 68 |
Outcome results
Primary
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score
Change over time in the primary outcome measure for this study, the WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). The scale ranges from 0-96 with higher scores indicating worse symptoms and function.
Time frame: baseline, 4 months, and 12 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score | Baseline to 4 Month Change | -6.73 units on a scale |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score | Baseline to 12 Month Change | -4.42 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score | Baseline to 4 Month Change | -6.06 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score | Baseline to 12 Month Change | -5.46 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score | Baseline to 4 Month Change | -3.37 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score | Baseline to 12 Month Change | -2.83 units on a scale |
Comparison: This is the comparison between Physical Therapy and Wait List Control at 4 months.p-value: 0.0695% CI: [-6.84, 0.12]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 12 months.p-value: 0.3995% CI: [-5.26, 2.08]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.p-value: 0.1495% CI: [-6.24, 0.85]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.p-value: 0.1795% CI: [-6.37, 1.11]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.p-value: 0.6595% CI: [-2.23, 3.56]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.p-value: 0.5195% CI: [-4.13, 2.05]Mixed Models Analysis
Secondary
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items
Number of minutes per week, on average, they are completing strengthening, stretching, and aerobic exercises. The minimum score is 0, and there is no maximum score; higher scores indicate more weekly activity.
Time frame: baseline, 4 months, and 12 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | Baseline to 4 Month Change - Strengthening Exercis | 1.78 minutes per week |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | Baseline to 12 Month Change - Strengthening Exerc | 1.07 minutes per week |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | Baseline to 4 Month Change - Stretching | 1.45 minutes per week |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | Baseline to 12 Month Change - Stretching | 0.27 minutes per week |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | Baseline to 4 Month Change - Aerobic Exercises | 1 minutes per week |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | Baseline to 12 Month Change - Aerobic Exercises | 0.48 minutes per week |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | Baseline to 12 Month Change - Aerobic Exercises | 0.41 minutes per week |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | Baseline to 4 Month Change - Strengthening Exercis | 1.27 minutes per week |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | Baseline to 12 Month Change - Stretching | 0.72 minutes per week |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | Baseline to 4 Month Change - Aerobic Exercises | 1.79 minutes per week |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | Baseline to 12 Month Change - Strengthening Exerc | 1.21 minutes per week |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | Baseline to 4 Month Change - Stretching | 0.97 minutes per week |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | Baseline to 12 Month Change - Strengthening Exerc | -0.14 minutes per week |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | Baseline to 4 Month Change - Stretching | -0.4 minutes per week |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | Baseline to 12 Month Change - Aerobic Exercises | -1.59 minutes per week |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | Baseline to 12 Month Change - Stretching | -1.34 minutes per week |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | Baseline to 4 Month Change - Strengthening Exercis | 0.43 minutes per week |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items | Baseline to 4 Month Change - Aerobic Exercises | -0.09 minutes per week |
Comparison: This is the comparison between Physical Therapy and Wait List Control at 4 months for Strengthening Exercisesp-value: 0.0495% CI: [0.05, 2.66]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 12 months for Strengthening Exercises.p-value: 0.0995% CI: [-0.18, 2.6]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Strengthening Exercises.p-value: 0.2295% CI: [-0.49, 2.19]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Strengthening Exercises.p-value: 0.0695% CI: [-0.08, 2.78]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Strength.p-value: 0.3695% CI: [-1.6, 0.58]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Strength.p-value: 0.8195% CI: [-1.03, 1.31]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 4 months for Stretching.p-value: 095% CI: [0.67, 3.03]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 12 months for Stretching.p-value: 095% CI: [0.55, 2.68]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Stretching.p-value: 0.0395% CI: [0.16, 2.57]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Stretching.p-value: 095% CI: [0.98, 3.16]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Stretching.p-value: 0.3395% CI: [-1.46, 0.5]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Stretching.p-value: 0.3295% CI: [-0.44, 1.34]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 4 months for Aerobic Exercise.p-value: 0.2195% CI: [-0.61, 2.8]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 12 months for Aerobic Exercise.p-value: 0.0495% CI: [0.13, 4]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Aerobic Exercise.p-value: 0.0395% CI: [0.15, 3.62]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Aerobic Exercise.p-value: 0.0595% CI: [0.01, 3.97]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Aerobic Exercise.p-value: 0.2795% CI: [-0.62, 2.2]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Aerobic Exercise.p-value: 0.9395% CI: [-1.69, 1.54]Mixed Models Analysis
Secondary
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test
One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the 2 minute step test, the minimum is 0 steps and there is no maximum scale score (participants complete as many steps as they can in 2 minutes); greater steps indicate better function.
Time frame: baseline, 4 months, and 12 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test | Baseline to 4 Month Change | -0.68 number of steps taken in 2 minutes |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test | Baseline to 12 Month Change | 1.11 number of steps taken in 2 minutes |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test | Baseline to 4 Month Change | -3.54 number of steps taken in 2 minutes |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test | Baseline to 12 Month Change | 1.12 number of steps taken in 2 minutes |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test | Baseline to 4 Month Change | -8.43 number of steps taken in 2 minutes |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test | Baseline to 12 Month Change | 0.00 number of steps taken in 2 minutes |
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for the 2 Minute Step Test.p-value: 0.295% CI: [-2.56, 12.33]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for the 2 Minute Step Test.p-value: 0.7895% CI: [-6.74, 8.99]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for the 2 Minute Step Test.p-value: 0.3595% CI: [-8.94, 3.21]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 4 months for the 2 Minute Step Test.p-value: 0.0495% CI: [0.43, 15.07]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 12 months for the 2 Minute Step Test.p-value: 0.7895% CI: [-6.59, 8.82]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for the 2 Minute Step Test.p-value: 195% CI: [-6.4, 6.42]Mixed Models Analysis
Secondary
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand
One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the 30 second chair stand test, the minimum is 0 stands and there is no maximum scale score (participants complete as many stands as they can in 30 seconds; greater numbers of stands indicate better function.
Time frame: baseline, 4 months, and 12 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand | Baseline to 4 Month Change | -0.13 number of stands from a chair in 30 sec |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand | Baseline to 12 Month Change | 0.16 number of stands from a chair in 30 sec |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand | Baseline to 4 Month Change | 0.50 number of stands from a chair in 30 sec |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand | Baseline to 12 Month Change | 0.90 number of stands from a chair in 30 sec |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand | Baseline to 4 Month Change | 0.18 number of stands from a chair in 30 sec |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand | Baseline to 12 Month Change | 0.66 number of stands from a chair in 30 sec |
Comparison: This is the comparison between Physical Therapy and Wait List Control at 4 months for 30 Second Chair Stand.p-value: 0.6395% CI: [-1.55, 0.94]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 12 months for 30 Second Chair Stand.p-value: 0.3795% CI: [-1.58, 0.6]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for 30 Second Chair Stand.p-value: 0.6295% CI: [-0.95, 1.59]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for 30 Second Chair Stand.p-value: 0.6795% CI: [-0.87, 1.35]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for 30 Second Chair Stand.p-value: 0.2395% CI: [-0.4, 1.66]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for 30 Second Chair Stand.p-value: 0.1195% CI: [-0.17, 1.64]Mixed Models Analysis
Secondary
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go
One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the timed up and go, there are no minimum or maximum scores (participants complete the task as quickly as they are able); shorter (lower) times indicate better function.
Time frame: baseline, 4 months, and 12 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go | Baseline to 4 Month Change | -0.62 seconds |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go | Baseline to 12 Month Change | -0.77 seconds |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go | Baseline to 4 Month Change | -0.87 seconds |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go | Baseline to 12 Month Change | -1.49 seconds |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go | Baseline to 4 Month Change | -0.23 seconds |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go | Baseline to 12 Month Change | -0.26 seconds |
Comparison: This is the comparison between Physical Therapy and Wait List Control at 4 months for Timed Up and Go.p-value: 0.5295% CI: [-1.58, 0.8]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 12 months for Timed Up and Go.p-value: 0.4695% CI: [-1.86, 0.85]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Timed Up and Go.p-value: 0.395% CI: [-1.85, 0.58]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Timed Up and Go.p-value: 0.0895% CI: [-2.61, 0.16]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Timed Up and Go.p-value: 0.6395% CI: [-1.23, 0.74]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Timed Up and Go.p-value: 0.2195% CI: [-1.85, 0.41]Mixed Models Analysis
Secondary
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time
One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the unilateral stand test, scores scan range from 0-10 seconds, with higher time indicating better balance.
Time frame: baseline, 4 months, and 12 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time | Baseline to 4 Month Change | -0.59 seconds |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time | Baseline to 12 Month Change | -0.05 seconds |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time | Baseline to 4 Month Change | 0.02 seconds |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time | Baseline to 12 Month Change | -0.05 seconds |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time | Baseline to 4 Month Change | 0.04 seconds |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time | Baseline to 12 Month Change | -0.09 seconds |
Comparison: This is the comparison between Physical Therapy and Wait List Control at 4 months for Unilateral Stand Time.p-value: 0.1995% CI: [-1.56, 0.3]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 12 months for Unilateral Stand Time.p-value: 0.9395% CI: [-0.89, 0.98]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Unilateral Stand Time.p-value: 0.9795% CI: [-0.97, 0.93]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Unilateral Stand Timep-value: 0.9395% CI: [-0.91, 1]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Unilateral Stand Time.p-value: 0.1295% CI: [-0.16, 1.38]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Unilateral Stand Time.p-value: 195% CI: [-0.78, 0.77]Mixed Models Analysis
Secondary
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8
Depressive symptoms and severity will be assessed using the PHQ-8, a reliable and valid measure of depression71. The PHQ-8 is an eight-item survey derived from the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic tool, and consists of items corresponding to the depression criteria listed in the Diagnostic and Statistics Manual Fourth Edition (DSM-IV). Each of the eight questions is scored as 0 (not at all) to 3 (nearly every day), so that total scores range from 0 to 24, with higher scores indicating more depressive symptoms.
Time frame: baseline, 4 months, and 12 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8 | Baseline to 4 Month Change | -0.46 units on a scale |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8 | Baseline to 12 Month Change | 0.1 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8 | Baseline to 4 Month Change | -0.22 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8 | Baseline to 12 Month Change | 0.1 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8 | Baseline to 4 Month Change | 0.33 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8 | Baseline to 12 Month Change | 0.99 units on a scale |
Comparison: This is the comparison between Physical Therapy and Wait List Control at 4 months.p-value: 0.0595% CI: [-1.59, 0.02]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 12 months.p-value: 0.0595% CI: [-1.82, 0.02]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.p-value: 0.1995% CI: [-1.37, 0.27]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.p-value: 0.0695% CI: [-1.83, 0.05]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.p-value: 0.4995% CI: [-0.43, 0.89]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.p-value: 0.9995% CI: [-0.77, 0.78]Mixed Models Analysis
Secondary
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE)
The Physical Activity Scale for the Elderly (PASE) is a self-report, 12-item scale that measures level occupational, household, and leisure activity during a one-week period. This scale was particularly developed for use among older adults; although all participants in the proposed study will not be age 65 or over, patients with knee OA typically have more limited physical activity than the general population. Therefore we believe this scale will be more applicable to our participant group than scales that were developed for younger adults. The typical range for the total PASE score is 0-400, with higher scores indicating greater activity.
Time frame: baseline, 4 months, and 12 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE) | Baseline to 4 Month Change | 2.25 units on a scale |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE) | Baseline to 12 Month Change | 8.28 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE) | Baseline to 4 Month Change | -11.52 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE) | Baseline to 12 Month Change | 8.19 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE) | Baseline to 4 Month Change | -4.7 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE) | Baseline to 12 Month Change | 1.17 units on a scale |
Comparison: This is the comparison between Physical Therapy and Wait List Control at 4 months.p-value: 0.4895% CI: [-12.31, 26.22]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 12 months.p-value: 0.4195% CI: [-9.69, 23.91]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.p-value: 0.595% CI: [-26.55, 12.91]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.p-value: 0.4395% CI: [-10.31, 24.35]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.p-value: 0.0995% CI: [-29.73, 2.19]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.p-value: 0.9995% CI: [-14.41, 14.23]Mixed Models Analysis
Secondary
Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument
The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. It assesses fatigue over the past seven days, This scale includes 8 items, each measured on a 5-point Likert scale. Per PROMIS scoring instructions, raw scores are converted into standardized t-scores with a mean of 50 and standard deviation of 10. T-scores can range from 33.1-77.8; higher scores indicate worse fatigue.
Time frame: baseline, 4 months, and 12 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument | Baseline to 4 Month Change | -0.91 units on a scale |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument | Baseline to 12 Month Change | 0.09 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument | Baseline to 4 Month Change | 0.57 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument | Baseline to 12 Month Change | 0.88 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument | Baseline to 4 Month Change | 1.55 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument | Baseline to 12 Month Change | 2.52 units on a scale |
Comparison: This is the comparison between Physical Therapy and Wait List Control at 4 months.p-value: 0.0395% CI: [-4.67, -0.26]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 12 months.p-value: 0.0195% CI: [-4.31, -0.55]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.p-value: 0.3995% CI: [-3.24, 1.27]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.p-value: 0.195% CI: [-3.58, 0.29]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.p-value: 0.1195% CI: [-0.33, 3.29]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.p-value: 0.3395% CI: [-0.8, 2.37]Mixed Models Analysis
Secondary
Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument
The PROMIS adult sleep related impairment item bank focuses on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. It assesses sleep-related impairment over the past seven days. This scale includes 8 items, each measured on a 5-point Likert scale. Per PROMIS scoring instructions, raw scores are converted into standardized t-scores with a mean of 50 and standard deviation of 10. T-scores can range from 30.5-77.6; higher scores indicate worse sleep impairment.
Time frame: baseline, 4 months, and 12 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument | Baseline to 4 Month Change | -3.13 units on a scale |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument | Baseline to 12 Month Change | -2.16 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument | Baseline to 4 Month Change | -0.94 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument | Baseline to 12 Month Change | -0.45 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument | Baseline to 4 Month Change | -0.54 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument | Baseline to 12 Month Change | -1.1 units on a scale |
Comparison: This is the comparison between Physical Therapy and Wait List Control at 4 months.p-value: 0.0295% CI: [-4.67, -0.5]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 12 months.p-value: 0.3395% CI: [-3.22, 1.09]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.p-value: 0.7295% CI: [-2.52, 1.74]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.p-value: 0.5695% CI: [-1.56, 2.86]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.p-value: 0.0195% CI: [0.48, 3.9]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.p-value: 0.0695% CI: [-0.1, 3.52]Mixed Models Analysis
Secondary
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale
This is a validated, 5-item questionnaire that assesses patients' satisfaction with their ability to complete basic functional tasks that are often affected by lower extremity OA, including stair-climbing, walking, doing housework (light and heavy, and lifting and carrying). All 5 items are rated on a 7 point scale ranging from Very Dissatisfied (-3) Very Satisfied (+3). The total scale ranges from -15 to +15,with higher scores indicating greater satisfaction with function.
Time frame: baseline, 4 months, and 12 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale | Baseline to 4 Month Change | 0.84 units on a scale |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale | Baseline to 12 Month Change | 0.39 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale | Baseline to 4 Month Change | 0.35 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale | Baseline to 12 Month Change | 0.43 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale | Baseline to 4 Month Change | 0.28 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale | Baseline to 12 Month Change | 0.16 units on a scale |
Comparison: This is the comparison between Physical Therapy and Wait List Control at 4 months.p-value: 0.0195% CI: [0.15, 0.98]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 12 months.p-value: 0.2895% CI: [-0.19, 0.65]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.p-value: 0.7595% CI: [-0.35, 0.49]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.p-value: 0.2295% CI: [-0.16, 0.7]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.p-value: 095% CI: [-0.84, -0.16]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.p-value: 0.8395% CI: [-0.31, 0.39]Mixed Models Analysis
Secondary
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale
The Brief Fear of Movement Scale is a six item scale for assessing fear of movement in OA. The scale specifically assesses activity avoidance due to pain-related fear of movement. All items are measured on a 4-point scale from strongly agree to strongly disagree. The score ranges from 0-24 with higher scores indicating more fear of movement.
Time frame: baseline, 4 months, and 12 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale | Baseline to 4 Month Change | -0.34 units on a scale |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale | Baseline to 12 Month Change | 0.28 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale | Baseline to 4 Month Change | 0.01 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale | Baseline to 12 Month Change | 0.06 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale | Baseline to 4 Month Change | 0.45 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale | Baseline to 12 Month Change | 0.28 units on a scale |
Comparison: This is the comparison between Physical Therapy and Wait List Control at 4 months.p-value: 0.0695% CI: [-1.62, 0.04]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 12 months.p-value: 195% CI: [-0.77, 0.77]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.p-value: 0.3195% CI: [-1.29, 0.41]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.p-value: 0.5895% CI: [-1.01, 0.57]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.p-value: 0.3295% CI: [-0.33, 1.03]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.p-value: 0.5195% CI: [-0.86, 0.43]Mixed Models Analysis
Secondary
Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. Five KOOS subscale scores were administered: Pain (9 items), Function in daily living (17 items), Function in Sport and Recreation (5 items), and knee-related Quality of Life (4 items). All items are scored on 5-point Likert scales. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale
Time frame: baseline, 4 months, and 12 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 4 Month Change - KOOS Pain | 6.2 units on a scale |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 12 Month Change - KOOS Pain | 3.67 units on a scale |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 4 Month Change - KOOS ADL | 6.8 units on a scale |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 12 Month Change - KOOS ADL | 4.65 units on a scale |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 4 Month Change - KOOS Sport/Rec | 5.6 units on a scale |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 12 Month Change - KOOS Sport/Rec | 5.44 units on a scale |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 4 Month Change - KOOS QOL | 5.56 units on a scale |
| Standard Physical Therapy | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 12 Month Change - KOOS QOL | 4.21 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 4 Month Change - KOOS ADL | 5.47 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 4 Month Change - KOOS QOL | 5.9 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 12 Month Change - KOOS ADL | 4.99 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 4 Month Change - KOOS Sport/Rec | 5.4 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 12 Month Change - KOOS Sport/Rec | 5.98 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 4 Month Change - KOOS Pain | 7.77 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 12 Month Change - KOOS Pain | 6.18 units on a scale |
| Internet Based Exercise Training | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 12 Month Change - KOOS QOL | 6.8 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 4 Month Change - KOOS ADL | 3.37 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 12 Month Change - KOOS Pain | 2.82 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 4 Month Change - KOOS Pain | 3.84 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 12 Month Change - KOOS ADL | 2.2 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 4 Month Change - KOOS QOL | 2.27 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 12 Month Change - KOOS Sport/Rec | -0.03 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 4 Month Change - KOOS Sport/Rec | 1.69 units on a scale |
| Wait List Control | Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline to 12 Month Change - KOOS QOL | -0.93 units on a scale |
Comparison: This is the comparison between Standard Physical Therapy and Wait List Control at 4 months for KOOS Pain.p-value: 0.2595% CI: [-1.67, 6.4]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS Pain.p-value: 0.3695% CI: [-1.77, 4.92]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months for KOOS Pain.p-value: 0.1795% CI: [-1.11, 6.14]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS Pain.p-value: 0.0695% CI: [-0.19, 8.06]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS Pain.p-value: 0.1495% CI: [-1.08, 7.79]Mixed Models Analysis
Comparison: This is the comparison between Standard Physical Therapy and Wait List Control at 12 months for KOOS Pain.p-value: 0.795% CI: [-3.48, 5.18]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS ADL.p-value: 0.495% CI: [-4.43, 1.79]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS ADL.p-value: 0.8495% CI: [-2.93, 3.59]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 4 month for KOOS ADL.p-value: 0.2895% CI: [-1.73, 5.94]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 12 month for KOOS ADL.p-value: 0.1795% CI: [-1.2, 6.77]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS ADL.p-value: 0.0795% CI: [-0.32, 7.18]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS ADL.p-value: 0.2295% CI: [-1.44, 6.34]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS Sport/Rec.p-value: 0.9295% CI: [-4.47, 4.06]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS Sport/Rec.p-value: 0.8295% CI: [-4.15, 5.24]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS Sport/Rec.p-value: 0.1795% CI: [-1.59, 9]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS Sport/Rec.p-value: 0.0495% CI: [0.29, 11.74]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS Sport/Rec.p-value: 0.1495% CI: [-1.28, 9.1]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS Sport/Rec.p-value: 0.0595% CI: [-0.1, 11.03]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS QOL.p-value: 0.8695% CI: [-3.29, 3.96]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS QOL.p-value: 0.1595% CI: [-0.96, 6.13]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS QOL.p-value: 0.1195% CI: [-0.85, 8.11]Mixed Models Analysis
Comparison: This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS QOL.p-value: 095% CI: [3.39, 12.08]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS QOL.p-value: 0.1495% CI: [-1.08, 7.67]Mixed Models Analysis
Comparison: This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS QOL.p-value: 0.0295% CI: [0.92, 9.37]Mixed Models Analysis