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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD088852-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High intensity interval training (HIIT) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| 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 | Study completion (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Training Sessions Completed Per Week | Up to 2 training sessions were possible each week over the 12 week intervention | Weekly measures for 12 consecutive weeks |
| Total Number of Training Sessions Completed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yvonne Golightly, PT, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | percentage of participants | Baseline |
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Adverse event data were collected from Baseline through the 12 week follow-up visit (an overall total of 12 weeks).
Lab team members who became aware of any adverse event or unanticipated problems related to the study were to notify the PIs immediately. All adverse events and study-related safety events were collected by the study team. Aggregated unanticipated problems and adverse events were reviewed on a monthly basis, or more often if urgent matters arose.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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This was a single arm study so it is not known how HIIT compares to other exercise approaches or interventions for the management of knee OA.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yvonne Golightly, PhD | University of North Carolina at Chapel Hill/Thurston Arthritis Research Center | 919-966-0566 | golight@email.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2017 | Nov 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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Single Group assignment
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Total number of training sessions completed out of up to 24 sessions (2 per week over 12 weeks)
| 12 weeks |
| Total Number of Training Weeks Completed | Total number of training weeks (up to 12 weeks possible) | 12 weeks |
| 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. | Baseline,12 weeks |
| 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. | Baseline,12 weeks |
| 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. | Baseline, 12 weeks |
| 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. | Baseline, 12 weeks |
| Change in Number of Chair Stand Repetitions Completed | Number of chair stand repetitions completed in 30 seconds | Baseline, 12 weeks |
| Change in Stair Climb Test | Time in seconds to ascend and descend a flight of stairs | Baseline, 12 weeks |
| 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 | Baseline, 12 weeks |
| Change in Feet Together Stand | Feet together stand for up to 10 seconds without assistive device | Baseline, 12 weeks |
| 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 | Baseline, 12 weeks |
| Change in Tandem Stand | One foot in front of the other, heel touching toe, for up to 10 seconds | Baseline, 12 weeks |
| Change in One Leg Stand | One leg stand for up to 30 seconds | Baseline, 12 weeks |
| Change in Cardiorespiratory Fitness | Measure by peak oxygen consumption (VO2peak),to identify fitness level and evaluate cardiovascular effects. Test will establish individual training intensity. | Baseline, 12 weeks |
| Change in Whole Body Fat Mass | fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA) | Baseline, 12 weeks |
| Change in Lean Body Mass | lean body mass in kilograms, measured with DXA | Baseline, 12 weeks |
| Change in Visceral Fat | visceral fat in kilograms, measured with DXA | Baseline, 12 weeks |
| Change in Knee Strength | Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors | Baseline, 12 weeks |
| Lost to Follow-up |
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| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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| 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 | Posted | Number | percentage of participants | Study completion (12 weeks) |
|
|
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| Secondary | Average Number of Training Sessions Completed Per Week | Up to 2 training sessions were possible each week over the 12 week intervention | Posted | Mean | Standard Deviation | training sessions per week | Weekly measures for 12 consecutive weeks |
|
|
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| 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) | Posted | Mean | Standard Deviation | training sessions | 12 weeks |
|
|
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| Secondary | Total Number of Training Weeks Completed | Total number of training weeks (up to 12 weeks possible) | Posted | Mean | Standard Deviation | weeks | 12 weeks |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | percentage change in score | Baseline,12 weeks |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | percentage change in score | Baseline,12 weeks |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | percentage change in score | Baseline, 12 weeks |
|
|
|
| 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. | Originally planned to have participants perform 40-meter walk; however, due to lab space constraints, this was altered to a 20-meter walk instead. | Posted | Mean | 95% Confidence Interval | seconds | Baseline, 12 weeks |
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| Secondary | Change in Number of Chair Stand Repetitions Completed | Number of chair stand repetitions completed in 30 seconds | Posted | Mean | 95% Confidence Interval | number of chair stands | Baseline, 12 weeks |
|
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| Secondary | Change in Stair Climb Test | Time in seconds to ascend and descend a flight of stairs | Posted | Mean | 95% Confidence Interval | change in seconds | Baseline, 12 weeks |
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| 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 | Posted | Mean | 95% Confidence Interval | change in seconds | Baseline, 12 weeks |
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| Secondary | Change in Feet Together Stand | Feet together stand for up to 10 seconds without assistive device | All participants were able to complete Feet Together Stand at baseline and 12 weeks (no change). | Posted | Mean | 95% Confidence Interval | change in seconds | Baseline, 12 weeks |
|
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| 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 | Posted | Mean | 95% Confidence Interval | change in seconds | Baseline, 12 weeks |
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| Secondary | Change in Tandem Stand | One foot in front of the other, heel touching toe, for up to 10 seconds | Posted | Mean | 95% Confidence Interval | change in seconds | Baseline, 12 weeks |
|
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| Secondary | Change in One Leg Stand | One leg stand for up to 30 seconds | Posted | Mean | 95% Confidence Interval | change in seconds | Baseline, 12 weeks |
|
|
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| 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. | Posted | Mean | 95% Confidence Interval | change in liters/minute | Baseline, 12 weeks |
|
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| Secondary | Change in Whole Body Fat Mass | fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA) | Posted | Mean | 95% Confidence Interval | kilogram (kg) | Baseline, 12 weeks |
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| Secondary | Change in Lean Body Mass | lean body mass in kilograms, measured with DXA | Posted | Mean | 95% Confidence Interval | kilogram (kg) | Baseline, 12 weeks |
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| Secondary | Change in Visceral Fat | visceral fat in kilograms, measured with DXA | Posted | Mean | 95% Confidence Interval | kilogram (kg) | Baseline, 12 weeks |
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| Secondary | Change in Knee Strength | Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors | Posted | Mean | 95% Confidence Interval | change in maximum kilograms | Baseline, 12 weeks |
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
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| D012216 |
| Rheumatic Diseases |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| Title | Measurements |
|---|---|
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| Left knee extensors |
|