Knee Osteoarthritis
Conditions
Keywords
Knee osteoarthritis
Brief summary
The focus of this pilot study is to evaluate the feasibility of utilizing an evidenced-based high intensity interval training program (HIIT) to improve physical function in patients with knee osteoarthritis (OA).
Detailed description
All participants will be assigned to the single-arm of the study in which all participants will receive 12 weeks of HIIT, delivered twice per week. The primary outcome will examine the feasibility and acceptability of the 12 week HIIT program in patients with knee OA symptoms ranging from mild to severe. The investigators will determine adherence to and tolerability of HIIT, acceptability, and recruitment and retention rates during the 12 week program. Additional outcomes will include physical function, knee OA symptomatic burden (pain), static standing balance, isometric knee extensor and flexor strength, cardiorespiratory fitness, and body composition.
Interventions
BEHAVIORALHigh intensity interval training (HIIT)
Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.
Sponsors
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group assignment
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* between the ages of 40 and 75 years old * body mass index of 18.5-50 kg/m² * exhibits symptomatic knee OA, defined as a diagnosis of knee OA, as identified from University of North Carolina electronic medical records, and current knee symptoms in at least one knee, having a minimum score of 6 out of 20 on the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) pain subscale.
Exclusion criteria
* individuals diagnosed with a cardiovascular condition restricting exercise * individuals currently meeting Department of Health and Human Services Guidelines for physical activity (≥ 150 minutes per week * individuals currently doing HIIT * individuals currently participating in physical therapy for knee OA * individuals currently participating in another OA intervention study * received a corticosteroid or hyaluronic acid intra-articular injection in the knee during the previous 3 weeks or scheduled for during the intervention * diagnosis of gout in the knee * diagnosis of rheumatoid arthritis * diagnosis of fibromyalgia * other systemic rheumatic disease * severe dementia or other memory loss * active diagnosis of psychosis or uncontrolled substance abuse disorder * hospitalization for a stroke, heart attack, or heart failure, or had surgery for blocked arteries in the past 3 months * total joint replacement knee surgery, other knee surgery, meniscus tear, or anterior cruciate ligament (ACL) tear in the past 6 months * on a waiting list for total joint replacement * severely impaired hearing or speech * pregnant or planning to become pregnant while enrolled in the study * inability to speak English * serious or terminal illness as indicated by referral to hospice or palliative care * nursing home residence * inability to ride a stationary bike * any other health problems that would prohibit safe participation in the study * EKG results EKG suggesting the individual would not be able to safely participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Potential Participants Screened for the Study Who Are Enrolled | Baseline | Number of participants screened and enrolled divided by the total number of participants screened |
| Percentage of Enrolled Participants Retained at the End of the Study | Study completion (12 weeks) | Number of participants who completed the study (baseline through 12 week assessments) divided by the total number of enrolled participants with baseline assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Training Weeks Completed | 12 weeks | Total number of training weeks (up to 12 weeks possible) |
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks | Baseline,12 weeks | The WOMAC, a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), will be used to measure overall symptomatic burden of knee osteoarthritis (OA). Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a total WOMAC score ranging from 0 (no problems) to 96 (extreme problems). A higher score means a worse outcome. |
| Change in WOMAC Pain Subscale From Baseline to 12 Weeks | Baseline,12 weeks | The WOMAC pain subscale contains 5 items about knee pain. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no pain) to 20 (extreme pain). A higher score means more severe pain. |
| Change in WOMAC Function Subscale From Baseline to 12 Weeks | Baseline, 12 weeks | The WOMAC function subscale contains 17 items about knee function during daily activities. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no problems with function) to 68 (extreme problems with function). A higher score means worse function. |
| Change in 20m Fast Paced Walk Test | Baseline, 12 weeks | Measure of the ability to walk quickly over short distances. Participants walk at fast pace that is timed over 2 x 10m. |
| Change in Number of Chair Stand Repetitions Completed | Baseline, 12 weeks | Number of chair stand repetitions completed in 30 seconds |
| Change in Stair Climb Test | Baseline, 12 weeks | Time in seconds to ascend and descend a flight of stairs |
| Change in Timed Up and Go | Baseline, 12 weeks | Time in seconds to rise from a chair, walk 3 m, turn, walk back to chair, and sit down |
| Average Number of Training Sessions Completed Per Week | Weekly measures for 12 consecutive weeks | Up to 2 training sessions were possible each week over the 12 week intervention |
| Change in Semi-tandem Stand | Baseline, 12 weeks | Heel of one foot placed to the side of the big toe of the other foot, for up to 10 seconds |
| Change in Tandem Stand | Baseline, 12 weeks | One foot in front of the other, heel touching toe, for up to 10 seconds |
| Change in One Leg Stand | Baseline, 12 weeks | One leg stand for up to 30 seconds |
| Change in Cardiorespiratory Fitness | Baseline, 12 weeks | Measure by peak oxygen consumption (VO2peak),to identify fitness level and evaluate cardiovascular effects. Test will establish individual training intensity. |
| Change in Whole Body Fat Mass | Baseline, 12 weeks | fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA) |
| Change in Lean Body Mass | Baseline, 12 weeks | lean body mass in kilograms, measured with DXA |
| Change in Visceral Fat | Baseline, 12 weeks | visceral fat in kilograms, measured with DXA |
| Change in Knee Strength | Baseline, 12 weeks | Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors |
| Change in Feet Together Stand | Baseline, 12 weeks | Feet together stand for up to 10 seconds without assistive device |
| Total Number of Training Sessions Completed | 12 weeks | Total number of training sessions completed out of up to 24 sessions (2 per week over 12 weeks) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods. | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | scheduling conflict, family circumstance | 2 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 63 years |
| BMI | 31.8 kg/m^2 STANDARD_DEVIATION 6.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 29 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
Percentage of Enrolled Participants Retained at the End of the Study
Number of participants who completed the study (baseline through 12 week assessments) divided by the total number of enrolled participants with baseline assessments
Time frame: Study completion (12 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Percentage of Enrolled Participants Retained at the End of the Study | 72.4 percentage of participants |
Primary
Percent of Potential Participants Screened for the Study Who Are Enrolled
Number of participants screened and enrolled divided by the total number of participants screened
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Percent of Potential Participants Screened for the Study Who Are Enrolled | 19.3 percentage of participants |
Secondary
Average Number of Training Sessions Completed Per Week
Up to 2 training sessions were possible each week over the 12 week intervention
Time frame: Weekly measures for 12 consecutive weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Average Number of Training Sessions Completed Per Week | 1.9 training sessions per week | Standard Deviation 0.24 |
Secondary
Change in 20m Fast Paced Walk Test
Measure of the ability to walk quickly over short distances. Participants walk at fast pace that is timed over 2 x 10m.
Time frame: Baseline, 12 weeks
Population: Originally planned to have participants perform 40-meter walk; however, due to lab space constraints, this was altered to a 20-meter walk instead.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in 20m Fast Paced Walk Test | -1.13 seconds |
Secondary
Change in Cardiorespiratory Fitness
Measure by peak oxygen consumption (VO2peak),to identify fitness level and evaluate cardiovascular effects. Test will establish individual training intensity.
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Cardiorespiratory Fitness | 0.14 change in liters/minute |
Secondary
Change in Feet Together Stand
Feet together stand for up to 10 seconds without assistive device
Time frame: Baseline, 12 weeks
Population: All participants were able to complete Feet Together Stand at baseline and 12 weeks (no change).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Feet Together Stand | 0.00 change in seconds |
Secondary
Change in Knee Strength
Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors
Time frame: Baseline, 12 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Change in Knee Strength | Right knee flexors | 3.34 change in maximum kilograms |
| Intervention | Change in Knee Strength | Left knee flexors | -0.84 change in maximum kilograms |
| Intervention | Change in Knee Strength | Right knee extensors | 9.99 change in maximum kilograms |
| Intervention | Change in Knee Strength | Left knee extensors | 9.86 change in maximum kilograms |
Secondary
Change in Lean Body Mass
lean body mass in kilograms, measured with DXA
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Lean Body Mass | -0.12 kilogram (kg) |
Secondary
Change in Number of Chair Stand Repetitions Completed
Number of chair stand repetitions completed in 30 seconds
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Number of Chair Stand Repetitions Completed | 2.6 number of chair stands |
Secondary
Change in One Leg Stand
One leg stand for up to 30 seconds
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in One Leg Stand | 3.41 change in seconds |
Secondary
Change in Semi-tandem Stand
Heel of one foot placed to the side of the big toe of the other foot, for up to 10 seconds
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Semi-tandem Stand | 0.52 change in seconds |
Secondary
Change in Stair Climb Test
Time in seconds to ascend and descend a flight of stairs
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Stair Climb Test | -1.42 change in seconds |
Secondary
Change in Tandem Stand
One foot in front of the other, heel touching toe, for up to 10 seconds
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Tandem Stand | 0.39 change in seconds |
Secondary
Change in Timed Up and Go
Time in seconds to rise from a chair, walk 3 m, turn, walk back to chair, and sit down
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Timed Up and Go | -0.58 change in seconds |
Secondary
Change in Visceral Fat
visceral fat in kilograms, measured with DXA
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Visceral Fat | -0.19 kilogram (kg) |
Secondary
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks
The WOMAC, a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), will be used to measure overall symptomatic burden of knee osteoarthritis (OA). Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a total WOMAC score ranging from 0 (no problems) to 96 (extreme problems). A higher score means a worse outcome.
Time frame: Baseline,12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks | -9.2 percentage change in score |
Secondary
Change in Whole Body Fat Mass
fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA)
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Whole Body Fat Mass | -0.28 kilogram (kg) |
Secondary
Change in WOMAC Function Subscale From Baseline to 12 Weeks
The WOMAC function subscale contains 17 items about knee function during daily activities. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no problems with function) to 68 (extreme problems with function). A higher score means worse function.
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in WOMAC Function Subscale From Baseline to 12 Weeks | -6.3 percentage change in score |
Secondary
Change in WOMAC Pain Subscale From Baseline to 12 Weeks
The WOMAC pain subscale contains 5 items about knee pain. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no pain) to 20 (extreme pain). A higher score means more severe pain.
Time frame: Baseline,12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in WOMAC Pain Subscale From Baseline to 12 Weeks | -1.7 percentage change in score |
Secondary
Total Number of Training Sessions Completed
Total number of training sessions completed out of up to 24 sessions (2 per week over 12 weeks)
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Total Number of Training Sessions Completed | 19.4 training sessions | Standard Deviation 7.4 |
Secondary
Total Number of Training Weeks Completed
Total number of training weeks (up to 12 weeks possible)
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Total Number of Training Weeks Completed | 11.4 weeks | Standard Deviation 1.47 |