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NCT Number: NCT07219732

Boosting Exercise Adherence in Knee Osteoarthritis

This project, conducted within the Department of Veterans Affairs Healthcare System (VHA), will test the effectiveness of an intervention to improve adherence to home exercise among Veterans receiving physical therapy (PT) for knee osteoarthritis (OA). The intervention, "Boosting Exercise Adherence in Knee Osteoarthritis" (BOOST-OA), has two phases. During the initiation phase (first 3 months of PT care), patients will receive tools and activities to address outcome expectations, action self-efficacy, goal-setting and monitoring. During the behavior maintenance phase (starting after PT care and continuing for 9 months), patients will receive health coaching calls that address satisfaction with outcomes, relapse prevention planning and independent monitoring. There are three main study aims: (1) examine improvements in patient outcomes, such as physical function, following BOOST-OA; (2) explore patient characteristics that lead to difference in reported improvements; and (3) interview participants and clinicians about their experience with BOOST-OA to inform future implementation.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Behavior Health Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

In this project, the investigators will test the effectiveness of a theoretically-informed, scalable intervention to enhance adherence to home exercise among Veterans receiving PT for knee OA. "Boosting Exercise Adherence in Knee Osteoarthritis" (BOOST-OA) includes components that address both exercise behavior initiation (conducted in conjunction with the PT episode of care) and maintenance (conducted after completion of PT care). Specifically, BOOST-OA includes: 1) Tools and activities woven into PT visits that address outcome expectations, action self-efficacy, goal-setting and monitoring (3-month behavior initiation phase) and 2) Health coaching calls that address satisfaction with outcomes, relapse prevention planning and independent monitoring (9-month behavior maintenance phase). This project is being conducted within the Department of Veterans Affairs Healthcare system (VHA). Specific aims are:

  • Aim 1. Examine the effectiveness of BOOST-OA for improving physical function and other key outcomes among Veterans receiving outpatient PT for knee OA using a pragmatic cluster-randomized trial, with 8 VA PT clinics randomized to BOOST-OA vs. usual PT care (UC). Participants will be Veterans with symptomatic knee OA (n=360, 45 per site/180 per study arm). At BOOST-OA sites, behavior initiation components will be provided in conjunction with standard PT visits, and a health coach will deliver maintenance components via telehealth.
  • Aim 2. Explore patient characteristics associated with differential improvement following BOOST-OA via a machine learning approach using model-based recursive partitioning. All participant characteristics, social determinants of health (SDOH), and baseline levels of study outcomes will be included in these analyses.
  • Aim 3: Conduct qualitative analyses of Veteran and PT clinician experiences with BOOST-OA to inform future implementation. The investigators will conduct semi-structured interviews with Veterans (n=36 across BOOST-OA sites and a subset of UC sites) and PT clinicians delivering care to BOOST-OA participants (n=8-12) to understand acceptability, feasibility, and perceived efficacy of the program, as well as barriers and facilitators to program participation and implementation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of knee OA (verified from the EHR)
  • Knee pain for 3 months
  • Knee pain on most days of the previous month,
  • Average knee pain 3 (on a scale of 0-10),
  • Self-report of some difficulty with walking or stair climbing.

Exclusion criteria

  • Systemic rheumatic conditions, fibromyalgia, gout (knee)
  • Dementia, psychosis or active substance abuse disorder
  • Meniscus or knee ligament tear in the past 6 months
  • Lower extremity surgery in past 6 months or planned in next 9 months
  • Severe hearing or visual impairment
  • Serious / terminal illness
  • Hospitalization for a cardiovascular event, past 3 months
  • Unstable angina
  • History of ventricular tachycardia
  • Unstable chronic obstructive pulmonary disease
  • Uncontrolled hypertension (diastolic >110 mm/Hg or systolic > 200mm/Hg)
  • Stroke with moderate to severe aphasia
  • History of three or more falls in past 6 months
  • Resident of a long-term care facility
  • Other health problem that would prohibit safe participation in the study or home exercise
  • Current participation in another OA intervention study
  • Currently meeting Department of Health and Human Services physical activity recommendations
  • Completed PT for knee OA in the past year
  • Unable to speak sufficient English to participate in study activities

Treatment and study plan

Usual PT Care (UC)

Behavioral

UC will be delivered by trained clinicians at participating sites. The study team will provide clinicians with guidance and training to standardize core aspects of PT, aligned with best practice recommendations. Clinicians must provide enrolled Veterans with at least 4 PT visits, spaced at least weekly so that Veterans can practice home exercise and receive guidance in exercise progression. All PT visits must be completed within 3 months.

BOOST-OA

Behavioral

BOOST-OA includes components that are integrated into PT visits (concurrent), focused on behavior initiation, as well as components that occur after PT visits have ended (sequential), focused on behavior maintenance. Concurrent components will be delivered in conjunction with usual care PT visits. Clinicians must provide enrolled Veterans with at least 4 PT visits, spaced at least weekly. PT visits must be also completed within 3 months. Sequential components will be delivered by a health coach via phone or video. Health coach sessions will be conducted every other week for the first 2 months (months 4-5), monthly for an additional 3 months (months 6- 8), and every other month for the last 4 months (months 9-12; 9 total contacts). Calls will address strengthening and stretching exercises (≥3 times per week), as well as overall physical activity (e.g., minutes / steps).

Primary outcomes

  1. Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale

    Time frame: Baseline

    The investigators selected physical function as the primary outcome because of its high importance to individuals with knee OA and its relevance for PT and exercise-based interventions. The WOMAC has been used widely in the context of clinical trials for knee OA and has well established psychometric properties including reliability, construct validity, internal consistency, and sensitivity to change in the context of behavioral interventions for knee OA. The WOMAC function subscale consists of 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty).

  2. Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale

    Time frame: Change from baseline to 3-months

    The investigators selected physical function as the primary outcome because of its high importance to individuals with knee OA and its relevance for PT and exercise-based interventions. The WOMAC has been used widely in the context of clinical trials for knee OA and has well established psychometric properties including reliability, construct validity, internal consistency, and sensitivity to change in the context of behavioral interventions for knee OA. The WOMAC function subscale consists of 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty).

  3. Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale

    Time frame: Change from baseline to 12-months (primary outcome time point)

    The investigators selected physical function as the primary outcome because of its high importance to individuals with knee OA and its relevance for PT and exercise-based interventions. The WOMAC has been used widely in the context of clinical trials for knee OA and has well established psychometric properties including reliability, construct validity, internal consistency, and sensitivity to change in the context of behavioral interventions for knee OA. The WOMAC function subscale consists of 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty).

  4. Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale

    Time frame: Change from baseline to 18-months

    The investigators selected physical function as the primary outcome because of its high importance to individuals with knee OA and its relevance for PT and exercise-based interventions. The WOMAC has been used widely in the context of clinical trials for knee OA and has well established psychometric properties including reliability, construct validity, internal consistency, and sensitivity to change in the context of behavioral interventions for knee OA. The WOMAC function subscale consists of 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty).

  5. Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale

    Time frame: Change from baseline to 24-months

    The investigators selected physical function as the primary outcome because of its high importance to individuals with knee OA and its relevance for PT and exercise-based interventions. The WOMAC has been used widely in the context of clinical trials for knee OA and has well established psychometric properties including reliability, construct validity, internal consistency, and sensitivity to change in the context of behavioral interventions for knee OA. The WOMAC function subscale consists of 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty).

Secondary outcomes

  1. Patient Specific Functional Scale

    Time frame: Baseline

    This modified version of the Patient Specific Functional Scale will ask participants to identify one important activity they are unable to do or are having difficulty with as a result of their knee OA. They then rate their ability to perform the identified activity from 0=unable to perform to 10=able to perform at the same level as before having knee OA.

  2. 30-second Chair Stand

    Time frame: Baseline

    The number of times that a participant can stand up from a seated position and sit back down in 30-seconds.

  3. 2-minute Step Test

    Time frame: Baseline

    The number of times a participant can step in place in a 2-minute period.

  4. WOMAC pain subscale

    Time frame: Baseline

    In addition to the WOMAC function subscale, the investigators will assess the WOMAC pain subscale (score range 0-20, higher scores indicate greater pain severity).

  5. WOMAC Total Score

    Time frame: Baseline

    The investigators will combine WOMAC subscales to calculate a total score (score range 0-96, higher scores indicate greater pain, stiffness, and functional limitation).

  6. Patient Specific Functional Scale

    Time frame: Change from baseline to 3-months

    This modified version of the Patient Specific Functional Scale will ask participants to identify one important activity they are unable to do or are having difficulty with as a result of their knee OA. They then rate their ability to perform the identified activity from 0=unable to perform to 10=able to perform at the same level as before having knee OA.

  7. Minutes of physical activity

    Time frame: Baseline

    The investigators will utilize validated algorithms to calculate average minutes of light and moderate-to-vigorous physical activity per day assessed by accelerometer.

  8. Patient Specific Functional Scale

    Time frame: Change from baseline to 12-months (primary outcome time point)

    This modified version of the Patient Specific Functional Scale will ask participants to identify one important activity they are unable to do or are having difficulty with as a result of their knee OA. They then rate their ability to perform the identified activity from 0=unable to perform to 10=able to perform at the same level as before having knee OA.

  9. Patient Specific Functional Scale

    Time frame: Change from baseline to 18-months

    This modified version of the Patient Specific Functional Scale will ask participants to identify one important activity they are unable to do or are having difficulty with as a result of their knee OA. They then rate their ability to perform the identified activity from 0=unable to perform to 10=able to perform at the same level as before having knee OA.

  10. Patient Specific Functional Scale

    Time frame: Change from baseline to 24-months

    This modified version of the Patient Specific Functional Scale will ask participants to identify one important activity they are unable to do or are having difficulty with as a result of their knee OA. They then rate their ability to perform the identified activity from 0=unable to perform to 10=able to perform at the same level as before having knee OA.

  11. Minutes of physical activity

    Time frame: Change from baseline to 12-months (primary outcome time point)

    The investigators will utilize validated algorithms to calculate average minutes of light and moderate-to-vigorous physical activity per day assessed by accelerometer.

  12. Minutes of physical activity

    Time frame: Change from baseline to 24-months

    The investigators will utilize validated algorithms to calculate average minutes of light and moderate-to-vigorous physical activity per day assessed by accelerometer.

  13. 30-second Chair Stand

    Time frame: Change from baseline to 3-months

    The number of times that a participant can stand up from a seated position and sit back down in 30-seconds.

  14. 30-second Chair Stand

    Time frame: Change from baseline to 12-months (primary outcome time point)

    The number of times that a participant can stand up from a seated position and sit back down in 30-seconds.

  15. 30-second Chair Stand

    Time frame: Change from baseline to 18-months

    The number of times that a participant can stand up from a seated position and sit back down in 30-seconds.

  16. 30-second Chair Stand

    Time frame: Change from baseline to 24-months

    The number of times that a participant can stand up from a seated position and sit back down in 30-seconds.

  17. 2-minute Step Test

    Time frame: Change from baseline to 3-months

    The number of times a participant can step in place in a 2-minute period.

  18. 2-minute Step Test

    Time frame: Change from baseline to 12-months (primary outcome time point)

    The number of times a participant can step in place in a 2-minute period.

  19. 2-minute Step Test

    Time frame: Change from baseline to 18-months

    The number of times a participant can step in place in a 2-minute period.

  20. 2-minute Step Test

    Time frame: Change from baseline to 24-months

    The number of times a participant can step in place in a 2-minute period.

  21. WOMAC pain subscale

    Time frame: Change from baseline to 3-months

    In addition to the WOMAC function subscale, the investigators will assess the WOMAC pain subscale (score range 0-20, higher scores indicate greater pain severity).

  22. WOMAC pain subscale

    Time frame: Change from baseline to 12-months (primary outcome time point)

    In addition to the WOMAC function subscale, the investigators will assess the WOMAC pain subscale (score range 0-20, higher scores indicate greater pain severity).

  23. WOMAC pain subscale

    Time frame: Change from baseline to 18-months

    In addition to the WOMAC function subscale, the investigators will assess the WOMAC pain subscale (score range 0-20, higher scores indicate greater pain severity).

  24. WOMAC pain subscale

    Time frame: Change from baseline to 24-months

    In addition to the WOMAC function subscale, the investigators will assess the WOMAC pain subscale (score range 0-20, higher scores indicate greater pain severity).

  25. WOMAC Total Score

    Time frame: Change from baseline to 3-months

    The investigators will combine WOMAC subscales to calculate a total score (score range 0-96, higher scores indicate greater pain, stiffness, and functional limitation).

  26. WOMAC Total Score

    Time frame: Change from baseline to 12-months (primary outcome time point)

    The investigators will combine WOMAC subscales to calculate a total score (score range 0-96, higher scores indicate greater pain, stiffness, and functional limitation).

  27. WOMAC Total Score

    Time frame: Change from baseline to 18-months

    The investigators will combine WOMAC subscales to calculate a total score (score range 0-96, higher scores indicate greater pain, stiffness, and functional limitation).

  28. WOMAC Total Score

    Time frame: Change from baseline to 24-months

    The investigators will combine WOMAC subscales to calculate a total score (score range 0-96, higher scores indicate greater pain, stiffness, and functional limitation).

  29. Average Step Count

    Time frame: Baseline

    The investigators will utilize validated algorithms to calculate average steps per day assessed by accelerometer.

  30. Average Step Count

    Time frame: Change from baseline to 12-months (primary outcome time point)

    The investigators will utilize validated algorithms to calculate average steps per day assessed by accelerometer.

  31. Average Step Count

    Time frame: Change from baseline to 24-months

    The investigators will utilize validated algorithms to calculate average steps per day assessed by accelerometer.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer M Gierisch, PhD MA

CONTACT

[email protected]

(919) 286-0411 ext. 177330

Kelli D Allen, PhD

CONTACT

[email protected]

(919) 286-0411 ext. 7090

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Boosting Exercise Adherence in Knee Osteoarthritis (BOOST-OA)

Acronym: BOOST-OA

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Oct 22, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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