Knee Arthroplasty, Total, Knee Replacement, Total
Conditions
Keywords
knee, total knee replacement, physical therapy
Brief summary
The purpose of this pilot study is to examine the effectiveness of the Physical Activity and Symmetry (PAS) program, compared to an attention (ATT)control group, for patients with post-total knee arthroplasty (TKA). The investigators hypothesize that the PAS treatment will result in meaningful improvements in physical activity (PA) and joint loading symmetry compared to the ATT group.
Detailed description
Background and Significance: Total knee arthroplasty (TKA) has been shown to decrease pain and to improve range of motion and some aspects of physical function. However, accumulating evidence shows that patients have persistent deficits in other critical outcomes following TKA. First, the majority of patients do not substantially increase physical activity beyond levels prior to TKA, remaining well below Department of Health and Human Services recommendations and levels of healthy individuals. This has serious negative implications for both joint health and overall health. Second, studies show that gait asymmetries are common following TKA, such that patients continue to load the non-surgical leg more heavily during walking, even when the post-surgical leg is pain free. This places the contralateral limb at risk for developing or worsening osteoarthritis. Other research shows there is large variability in post-TKA rehabilitation, along with sub-optimal exercise content. Collectively, these findings emphasize the critical need to improve the post-TKA rehabilitation process. However, there are currently no evidence-based approaches to improve overall physical activity and deficits in joint loading symmetry that have been identified following TKA. Study Aims: This research project will provide important preliminary information on the novel post-TKA PAS program through achieving the following specific aims: 1) Obtain preliminary data on the efficacy of the PAS program with respect to the change in objectively assessed physical activity, measured via accelerometers; 2) Obtain preliminary data on the efficacy of the PAS program with respect to change in peak load symmetry during walking, measured by a novel 3-sensor insole device; 3) Assess the feasibility and acceptability of the PAS program following TKA. Study Description: Investigators will conduct an exploratory randomized controlled study, with n=60 patients \>=18 years receiving post-TKA physical therapy (PT) at a UNC Healthcare System clinic. Patients will be equally allocated to the PAS intervention or an attention (ATT) control group.
Interventions
BEHAVIORALPAS Intervention
The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
BEHAVIORALAttention Control
This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients receiving post-total knee arthroplasty (TKA) physical therapy (PT) at a University of North Carolina (UNC) Healthcare System clinic
Exclusion criteria
* significant cognitive impairment * neurological disorders affecting gait * systemic rheumatic disease * hospitalization for a cardiovascular condition the past six months * psychosis * substance abuse disorder * lower extremity surgery in the past year * any other health conditions determined to be contraindications to a home exercise program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Month 3 in Objectively Assessed Physical Activity (Accelerometer) | Baseline, Month 3 | Minutes of moderate to vigorous intensity PA (MVPA) per week measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. |
| Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer) | Baseline, Month 6 | Minutes of moderate to vigorous intensity PA (MVPA) per week measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. |
| Change From Baseline to Month 3 in Peak Joint Load Symmetry During Walking | Baseline, Month 3 | Participants will complete a 10 meter walking test while load beneath each foot is recorded using an instrumented insole. Loading symmetry (peak ground reaction force) will be assessed using the limb symmetry index (LSI (\|Surgical/Non-Surgical\|\*100), values lower than 100% indicate less loading of the surgical limb. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. |
| Change From Baseline to Month 6 in Peak Joint Load Symmetry During Walking | Baseline, Month 6 | Participants will complete a 10 meter walking test while load beneath each foot is recorded using an instrumented insole. Loading symmetry (peak ground reaction force) will be assessed using the limb symmetry index (LSI (\|Surgical/Non-Surgical\|\*100), values lower than 100% indicate less loading of the surgical limb. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Month 3 in Minutes of Any Physical Activity (PA) | Baseline, Month 3 | Minutes of any PA measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. |
| Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA) | Baseline, Month 6 | Minutes of any PA measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. |
| Change From Baseline to Month 3 in Sedentary Minutes | Baseline, Month 3 | Minutes of sedentary activity per day, measured via accelerometer |
| Change From Baseline to Month 6 in Sedentary Minutes | Baseline, Month 6 | Minutes of sedentary activity per day, measured via accelerometer |
| Change From Baseline to Month 3 in Berg Balance Scale | Baseline, Month 3 | Berg Balance Scale includes 14 tests of static and dynamic balance. Each item is scored along a 5-point scale, ranging from 0 to 4. Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56. Lower scores indicate reduced functional mobility. |
| Change From Baseline to Month 6 in Berg Balance Scale | Baseline, Month 6 | Berg Balance Scale includes 14 tests of static and dynamic balance. Each item is scored along a 5-point scale, ranging from 0 to 4. Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56. Lower scores indicate reduced functional mobility. |
| Change From Baseline to Month 3 in Self-Reported Physical Activity. | Baseline, Month 3 | Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. This outcome pertains to minutes of physical activity of moderate or greater intensity (metabolic equivalents ≥ 3.0). A square root transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. |
| Change From Baseline to Month 6 in Brief Balance Evaluation Systems Test | Baseline, Month 6 | Brief Balance Evaluation Systems includes 8 tasks across 6 domains. Each item is scored: 0-3 points (0 representing severe impairment and 3 representing no balance impairment), score range is 0-24. Lower scores indicate higher levels of balance impairment. |
| Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline, Month 3 | 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), Symptoms (7 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. |
| Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline, Month 6 | 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), Symptoms (7 it4ems) 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. |
| Change From Baseline to Month 3 in Tampa Scale for Kinesiophobia | Baseline, Month 3 | The Tampa Scale of Kinesiophobia is a 17 item scale for assessing fear of movement. 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. A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement. |
| Change From Baseline to Month 6 in Tampa Scale for Kinesiophobia | Baseline, Month 6 | The Tampa Scale of Kinesiophobia is a 17 item scale for assessing fear of movement. 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. A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement. |
| Change From Baseline to Month 3 in Brief Balance Evaluation Systems Test | Baseline, Month 3 | Brief Balance Evaluation Systems includes 8 tasks across 6 domains. Each item is scored: 0-3 points (0 representing severe impairment and 3 representing no balance impairment), score range is 0-24). Lower scores indicate higher levels of balance impairment. |
| Change From Baseline Month 6 in Self-Reported Physical Activity. | Baseline to Month 6 | Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. This outcome pertains to minutes of physical activity of moderate or greater intensity (metabolic equivalents ≥ 3.0). A square root transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. |
| Change From Baseline to Month 3 in Steps Per Day | Baseline, Month 3 | Step counts measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. |
| Change From Baseline to Month 6 in Steps Per Day | Baseline, Month 6 | Step counts measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Physical Activity and Symmetry (PAS) Intervention Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
PAS Intervention: The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability). | 30 |
| Attention Control Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Attention Control: This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Attention Control | Total | Physical Activity and Symmetry (PAS) Intervention |
|---|---|---|---|
| Age, Continuous | 66.1 years STANDARD_DEVIATION 7.2 | 66.2 years STANDARD_DEVIATION 7.5 | 66.2 years STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 60 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 46 Participants | 23 Participants |
| Region of Enrollment United States | 30 Participants | 60 Participants | 30 Participants |
| Sex: Female, Male Female | 18 Participants | 37 Participants | 19 Participants |
| Sex: Female, Male Male | 12 Participants | 23 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 6 / 30 | 1 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Change From Baseline to Month 3 in Objectively Assessed Physical Activity (Accelerometer)
Minutes of moderate to vigorous intensity PA (MVPA) per week measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Time frame: Baseline, Month 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 3 in Objectively Assessed Physical Activity (Accelerometer) | 0.59 Minutes per week |
| Attention Control | Change From Baseline to Month 3 in Objectively Assessed Physical Activity (Accelerometer) | 0.36 Minutes per week |
p-value: 0.48595% CI: [-0.9, 0.43]Mixed Models Analysis
Primary
Change From Baseline to Month 3 in Peak Joint Load Symmetry During Walking
Participants will complete a 10 meter walking test while load beneath each foot is recorded using an instrumented insole. Loading symmetry (peak ground reaction force) will be assessed using the limb symmetry index (LSI (\|Surgical/Non-Surgical\|\*100), values lower than 100% indicate less loading of the surgical limb. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Time frame: Baseline, Month 3
Population: This includes all participants with available insole data at baseline and 6-month follow-up. Some participants did not have usable insole data due to technical issues
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 3 in Peak Joint Load Symmetry During Walking | 0.04 percentage of non-surgical limb force |
| Attention Control | Change From Baseline to Month 3 in Peak Joint Load Symmetry During Walking | -0.02 percentage of non-surgical limb force |
p-value: 0.29695% CI: [-0.05, 0.13]Mixed Models Analysis
Primary
Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer)
Minutes of moderate to vigorous intensity PA (MVPA) per week measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer) | 0.12 Minutes per week |
| Attention Control | Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer) | 0.64 Minutes per week |
p-value: 0.088795% CI: [-1.13, 0.08]Mixed Models Analysis
Primary
Change From Baseline to Month 6 in Peak Joint Load Symmetry During Walking
Participants will complete a 10 meter walking test while load beneath each foot is recorded using an instrumented insole. Loading symmetry (peak ground reaction force) will be assessed using the limb symmetry index (LSI (\|Surgical/Non-Surgical\|\*100), values lower than 100% indicate less loading of the surgical limb. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Time frame: Baseline, Month 6
Population: This includes all participants with available insole data at baseline and 6-month follow-up. Some participants did not have usable insole data due to technical issues.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 6 in Peak Joint Load Symmetry During Walking | -0.05 percentage of non-surgical limb force |
| Attention Control | Change From Baseline to Month 6 in Peak Joint Load Symmetry During Walking | 0.02 percentage of non-surgical limb force |
p-value: 0.09495% CI: [-0.15, 0.01]Mixed Models Analysis
Secondary
Change From Baseline Month 6 in Self-Reported Physical Activity.
Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. This outcome pertains to minutes of physical activity of moderate or greater intensity (metabolic equivalents ≥ 3.0). A square root transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Time frame: Baseline to Month 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline Month 6 in Self-Reported Physical Activity. | 1.58 Minutes per week |
| Attention Control | Change From Baseline Month 6 in Self-Reported Physical Activity. | -0.16 Minutes per week |
p-value: 0.5595% CI: [-4.1, 7.59]Mixed Models Analysis
Secondary
Change From Baseline to Month 3 in Berg Balance Scale
Berg Balance Scale includes 14 tests of static and dynamic balance. Each item is scored along a 5-point scale, ranging from 0 to 4. Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56. Lower scores indicate reduced functional mobility.
Time frame: Baseline, Month 3
Population: We had to discontinue administration of balance measures for this study for an extended period of time due to COVID-19, as these tests require the test administrator to be in close proximity to the person being tested. Only 1 person completed all components of this balance test at both baseline and 3-month follow-up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Attention Control | Change From Baseline to Month 3 in Berg Balance Scale | -4 score on a scale |
Secondary
Change From Baseline to Month 3 in Brief Balance Evaluation Systems Test
Brief Balance Evaluation Systems includes 8 tasks across 6 domains. Each item is scored: 0-3 points (0 representing severe impairment and 3 representing no balance impairment), score range is 0-24). Lower scores indicate higher levels of balance impairment.
Time frame: Baseline, Month 3
Population: We had to discontinue administration of balance measures for this study for an extended period of time due to COVID-19, as these tests require the test administrator to be in close proximity to the person being tested. Only 1 person completed all components of this balance test at both baseline and 3-month follow-up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Attention Control | Change From Baseline to Month 3 in Brief Balance Evaluation Systems Test | 1 score on a scale |
Secondary
Change From Baseline to Month 3 in 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), Symptoms (7 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, Month 3
Population: Only 1 participant answered enough questions on the Function and Sport and Recreation Subscale to score this subscale, per instrument instructions. This is because in this post-surgical sample many still had activity restrictions and had been instructed to not yet engage in many of the activities on this subscale.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Symptoms | 23.16 score on a scale |
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Function in Daily Living | 20.91 score on a scale |
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Quality of Life | 29.12 score on a scale |
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Function in Sport and Recreation | 41.7 score on a scale |
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Pain | 28.70 score on a scale |
| Attention Control | Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Function in Sport and Recreation | 0 score on a scale |
| Attention Control | Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Pain | 26.19 score on a scale |
| Attention Control | Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Symptoms | 22.02 score on a scale |
| Attention Control | Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Quality of Life | 32.66 score on a scale |
| Attention Control | Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Function in Daily Living | 18.37 score on a scale |
Comparison: Pain subscalep-value: 0.4295% CI: [-3.65, 8.67]Mixed Models Analysis
Comparison: Symptoms subscalep-value: 0.7695% CI: [-6.29, 8.57]Mixed Models Analysis
Comparison: Quality of life subscalep-value: 0.4695% CI: [-13.2, 6.12]Mixed Models Analysis
Comparison: Function in daily lifep-value: 0.2295% CI: [-1.61, 6.69]Mixed Models Analysis
Secondary
Change From Baseline to Month 3 in Minutes of Any Physical Activity (PA)
Minutes of any PA measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Time frame: Baseline, Month 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 3 in Minutes of Any Physical Activity (PA) | 0.04 minutes per day |
| Attention Control | Change From Baseline to Month 3 in Minutes of Any Physical Activity (PA) | 0.09 minutes per day |
p-value: 0.2595% CI: [-0.16, 0.04]Mixed Models Analysis
Secondary
Change From Baseline to Month 3 in Sedentary Minutes
Minutes of sedentary activity per day, measured via accelerometer
Time frame: Baseline, Month 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 3 in Sedentary Minutes | -5.32 minutes per day |
| Attention Control | Change From Baseline to Month 3 in Sedentary Minutes | -26.68 minutes per day |
p-value: 0.16795% CI: [-9.29, 52.02]Mixed Models Analysis
Secondary
Change From Baseline to Month 3 in Self-Reported Physical Activity.
Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. This outcome pertains to minutes of physical activity of moderate or greater intensity (metabolic equivalents ≥ 3.0). A square root transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Time frame: Baseline, Month 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 3 in Self-Reported Physical Activity. | 3.23 minutes per week |
| Attention Control | Change From Baseline to Month 3 in Self-Reported Physical Activity. | -0.62 minutes per week |
p-value: 0.1195% CI: [-0.91, 8.62]Mixed Models Analysis
Secondary
Change From Baseline to Month 3 in Steps Per Day
Step counts measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Time frame: Baseline, Month 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 3 in Steps Per Day | 0.18 steps per day |
| Attention Control | Change From Baseline to Month 3 in Steps Per Day | 0.33 steps per day |
p-value: 0.13495% CI: [-0.34, 0.05]Mixed Models Analysis
Secondary
Change From Baseline to Month 3 in Tampa Scale for Kinesiophobia
The Tampa Scale of Kinesiophobia is a 17 item scale for assessing fear of movement. 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. A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement.
Time frame: Baseline, Month 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 3 in Tampa Scale for Kinesiophobia | -4.81 units on a scale |
| Attention Control | Change From Baseline to Month 3 in Tampa Scale for Kinesiophobia | -2.86 units on a scale |
p-value: 0.19195% CI: [-4.92, 1.01]Mixed Models Analysis
Secondary
Change From Baseline to Month 6 in Berg Balance Scale
Berg Balance Scale includes 14 tests of static and dynamic balance. Each item is scored along a 5-point scale, ranging from 0 to 4. Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56. Lower scores indicate reduced functional mobility.
Time frame: Baseline, Month 6
Population: We had to discontinue administration of balance measures for this study for an extended period of time due to COVID-19, as these tests require the test administrator to be in close proximity to the person being tested. No participants completed all components of this balance test at both baseline and 6-month follow-up.
Secondary
Change From Baseline to Month 6 in Brief Balance Evaluation Systems Test
Brief Balance Evaluation Systems includes 8 tasks across 6 domains. Each item is scored: 0-3 points (0 representing severe impairment and 3 representing no balance impairment), score range is 0-24. Lower scores indicate higher levels of balance impairment.
Time frame: Baseline, Month 6
Population: We had to discontinue administration of balance measures for this study for an extended period of time due to COVID-19, as these tests require the test administrator to be in close proximity to the person being tested. No participants completed all components of this balance test at both baseline and 6-month follow-up.
Secondary
Change From Baseline to Month 6 in 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), Symptoms (7 it4ems) 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, Month 6
Population: Only 2 participants answered enough questions on the Function and Sport and Recreation Subscale to score this subscale, per instrument instructions. This is because in this post-surgical sample many still had activity restrictions and had been instructed to not yet engage in many of the activities on this subscale. Therefore only four of the subscales were scored and analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Symptoms | 29.49 score on a scale |
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Function in daily life | 22.92 score on a scale |
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Quality of life | 36.47 score on a scale |
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Function in Sport and Recreation | 22.9 score on a scale |
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Pain | 30.16 score on a scale |
| Attention Control | Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Function in Sport and Recreation | 41.7 score on a scale |
| Attention Control | Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Pain | 28.72 score on a scale |
| Attention Control | Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Symptoms | 25.54 score on a scale |
| Attention Control | Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Quality of life | 34.83 score on a scale |
| Attention Control | Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Function in daily life | 19.67 score on a scale |
Comparison: Pain subscalep-value: 0.6595% CI: [-4.98, 7.85]Mixed Models Analysis
Comparison: Symptoms subscalep-value: 0.3295% CI: [-3.93, 11.83]Mixed Models Analysis
Comparison: Quality of lifep-value: 0.7795% CI: [-9.61, 12.89]Mixed Models Analysis
Comparison: Function in daily lifep-value: 0.1995% CI: [-1.67, 8.17]Mixed Models Analysis
Secondary
Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA)
Minutes of any PA measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA) | 0.00 minutes per day |
| Attention Control | Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA) | 0.09 minutes per day |
p-value: 0.1695% CI: [-0.22, 0.04]Mixed Models Analysis
Secondary
Change From Baseline to Month 6 in Sedentary Minutes
Minutes of sedentary activity per day, measured via accelerometer
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 6 in Sedentary Minutes | -1.37 minutes |
| Attention Control | Change From Baseline to Month 6 in Sedentary Minutes | -26.52 minutes |
p-value: 0.18995% CI: [-12.85, 63.14]Mixed Models Analysis
Secondary
Change From Baseline to Month 6 in Steps Per Day
Step counts measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 6 in Steps Per Day | 0.15 steps per day |
| Attention Control | Change From Baseline to Month 6 in Steps Per Day | 0.32 steps per day |
p-value: 0.0995% CI: [-0.38, 0.03]Mixed Models Analysis
Secondary
Change From Baseline to Month 6 in Tampa Scale for Kinesiophobia
The Tampa Scale of Kinesiophobia is a 17 item scale for assessing fear of movement. 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. A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity and Symmetry (PAS) Intervention | Change From Baseline to Month 6 in Tampa Scale for Kinesiophobia | -8.31 units on a scale |
| Attention Control | Change From Baseline to Month 6 in Tampa Scale for Kinesiophobia | -2.86 units on a scale |
p-value: 0.000495% CI: [-8.28, -2.62]Mixed Models Analysis