Osteoarthritis, KneeBOOST-OANCT07219732
Boosting Exercise Adherence in Knee Osteoarthritis
A study testing Usual PT Care (UC) and BOOST-OA in people with Osteoarthritis, Knee, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Usual PT Care (UC) and BOOST-OA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of knee osteoarthritis (verified from the Electronic Health Record)
- 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.
Who cannot join
- 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
Show all 19Show fewer
- Hospitalization for a cardiovascular event, past 3 months
- Unstable angina
- History of ventricular tachycardia
- Unstable chronic obstructive pulmonary disease
- Uncontrolled hypertension (diastolic >110 millimeters of mercury (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 physical therapy (PT) for knee OA in the past year
- Unable to speak sufficient English to participate in study activities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
Susanna B Oberg, AAS AAS, (615) 873-6955, susanna.oberg@va.gov
Heidi D Bassani, (919) 286-0411, Heidi.Bassani@va.gov
About this study
Official title: Boosting Exercise Adherence in Knee Osteoarthritis (BOOST-OA)
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.
Read the detailed description
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Usual PT Care (UC), BOOST-OA
- Keywords
- exercise, physical, physical therapy, health behavior
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual PT Care (UC)Behavioural
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 physical therapy (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-OABehavioural
BOOST-OA includes components that are integrated into physical therapy (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).
| Study group | Role | What they receive |
|---|---|---|
| Usual PT Care (UC) | Active comparator | 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 physical therapy (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. Receives: Behavioral: Usual PT Care (UC) |
| BOOST-OA | Experimental | BOOST-OA includes components that are integrated into physical therapy (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). Receives: Behavioral: BOOST-OA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale
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).
Measured: Baseline
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale
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).
Measured: Change from baseline to 3-months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale
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).
Measured: Change from baseline to 12-months (primary outcome time point)
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale
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).
Measured: Change from baseline to 18-months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale
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).
Measured: Change from baseline to 24-months
Secondary outcomes (31)
Patient Specific Functional Scale
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.
Measured: Baseline
30-second Chair Stand
The number of times that a participant can stand up from a seated position and sit back down in 30-seconds.
Measured: Baseline
2-minute Step Test
The number of times a participant can step in place in a 2-minute period.
Measured: Baseline
Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale
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).
Measured: Baseline
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score
The investigators will combine WOMAC subscales to calculate a total score (score range 0-96, higher scores indicate greater pain, stiffness, and functional limitation).
Measured: Baseline
Patient Specific Functional Scale
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.
Measured: Change from baseline to 3-months
Minutes of physical activity
The investigators will utilize validated algorithms to calculate average minutes of light and moderate-to-vigorous physical activity per day assessed by accelerometer.
Measured: Baseline
Patient Specific Functional Scale
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.
Measured: Change from baseline to 12-months (primary outcome time point)
Patient Specific Functional Scale
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.
Measured: Change from baseline to 18-months
Patient Specific Functional Scale
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.
Measured: Change from baseline to 24-months
Minutes of physical activity
The investigators will utilize validated algorithms to calculate average minutes of light and moderate-to-vigorous physical activity per day assessed by accelerometer.
Measured: Change from baseline to 12-months (primary outcome time point)
Minutes of physical activity
The investigators will utilize validated algorithms to calculate average minutes of light and moderate-to-vigorous physical activity per day assessed by accelerometer.
Measured: Change from baseline to 24-months
30-second Chair Stand
The number of times that a participant can stand up from a seated position and sit back down in 30-seconds.
Measured: Change from baseline to 3-months
30-second Chair Stand
The number of times that a participant can stand up from a seated position and sit back down in 30-seconds.
Measured: Change from baseline to 12-months (primary outcome time point)
30-second Chair Stand
The number of times that a participant can stand up from a seated position and sit back down in 30-seconds.
Measured: Change from baseline to 18-months
30-second Chair Stand
The number of times that a participant can stand up from a seated position and sit back down in 30-seconds.
Measured: Change from baseline to 24-months
2-minute Step Test
The number of times a participant can step in place in a 2-minute period.
Measured: Change from baseline to 3-months
2-minute Step Test
The number of times a participant can step in place in a 2-minute period.
Measured: Change from baseline to 12-months (primary outcome time point)
2-minute Step Test
The number of times a participant can step in place in a 2-minute period.
Measured: Change from baseline to 18-months
2-minute Step Test
The number of times a participant can step in place in a 2-minute period.
Measured: Change from baseline to 24-months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale
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).
Measured: Change from baseline to 3-months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale
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).
Measured: Change from baseline to 12-months (primary outcome time point)
Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale
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).
Measured: Change from baseline to 18-months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale
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).
Measured: Change from baseline to 24-months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score
The investigators will combine WOMAC subscales to calculate a total score (score range 0-96, higher scores indicate greater pain, stiffness, and functional limitation).
Measured: Change from baseline to 3-months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score
The investigators will combine WOMAC subscales to calculate a total score (score range 0-96, higher scores indicate greater pain, stiffness, and functional limitation).
Measured: Change from baseline to 12-months (primary outcome time point)
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score
The investigators will combine WOMAC subscales to calculate a total score (score range 0-96, higher scores indicate greater pain, stiffness, and functional limitation).
Measured: Change from baseline to 18-months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score
The investigators will combine WOMAC subscales to calculate a total score (score range 0-96, higher scores indicate greater pain, stiffness, and functional limitation).
Measured: Change from baseline to 24-months
Average Step Count
The investigators will utilize validated algorithms to calculate average steps per day assessed by accelerometer.
Measured: Baseline
Average Step Count
The investigators will utilize validated algorithms to calculate average steps per day assessed by accelerometer.
Measured: Change from baseline to 12-months (primary outcome time point)
Average Step Count
The investigators will utilize validated algorithms to calculate average steps per day assessed by accelerometer.
Measured: Change from baseline to 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study start30 Oct 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this randomized trial, 8 VHA sites will be randomized (1:1) to BOOST-OA or UC. A total of 45 participants will be enrolled at each site (n=180 per study arm). At BOOST-OA sites, behavior change initiation (concurrent) components will be delivered during the course of routine PT visits; these components are simply operationalizing "best practice" for supporting home exercise in the context of PT and not considered a new intervention. This will be followed by delivery of maintenance (sequential) components delivered virtually by a health coach; this is considered a new / experimental component of the intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kelli Dominick Allen, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219732
- Sponsor's protocol ID
- RRD2-002-24W
- Other IDs
- 1I01RD000435-01A1
- Acronym
- BOOST-OA
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset will be available upon request, as allowable under the regulations and policies of study sponsors. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format. Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication. No data or statistical code that could lead to re-identification of individuals will be released. Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re-identify any individual whose data are included in the dataset
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting Exercise Adherence in Knee Osteoarthritis (BOOST-OA)
- ClinicalTrials.gov ID
- NCT07219732
- Acronym / sponsor ID
- BOOST-OA / RRD2-002-24W
- Conditions
- Osteoarthritis, Knee
- Keywords
- exercise, physical, physical therapy, health behavior
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- In this randomized trial, 8 VHA sites will be randomized (1:1) to BOOST-OA or UC. A total of 45 participants will be enrolled at each site (n=180 per study arm). At BOOST-OA sites, behavior change initiation (concurrent) components will be delivered during the course of routine PT visits; these components are simply operationalizing "best practice" for supporting home exercise in the context of PT and not considered a new intervention. This will be followed by delivery of maintenance (sequential) components delivered virtually by a health coach; this is considered a new / experimental component of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Usual PT Care (UC) | Active comparator | Behavioral: Usual PT Care (UC)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 physical therapy (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 | Experimental | Behavioral: BOOST-OABOOST-OA includes components that are integrated into physical therapy (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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of knee osteoarthritis (verified from the Electronic Health Record)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual PT Care (UC)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 physical therapy (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. | Behavioural | Usual PT Care (UC) |
| BOOST-OABOOST-OA includes components that are integrated into physical therapy (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). | Behavioural | BOOST-OA |
Primary outcome
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).
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).
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).
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).
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).
31 secondary outcomes
Patient Specific Functional Scale
Time frame: Baseline
30-second Chair Stand
Time frame: Baseline
2-minute Step Test
Time frame: Baseline
Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale
Time frame: Baseline
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score
Time frame: Baseline
Patient Specific Functional Scale
Time frame: Change from baseline to 3-months
Minutes of physical activity
Time frame: Baseline
Patient Specific Functional Scale
Time frame: Change from baseline to 12-months (primary outcome time point)
Patient Specific Functional Scale
Time frame: Change from baseline to 18-months
Patient Specific Functional Scale
Time frame: Change from baseline to 24-months
Minutes of physical activity
Time frame: Change from baseline to 12-months (primary outcome time point)
Minutes of physical activity
Time frame: Change from baseline to 24-months
30-second Chair Stand
Time frame: Change from baseline to 3-months
30-second Chair Stand
Time frame: Change from baseline to 12-months (primary outcome time point)
30-second Chair Stand
Time frame: Change from baseline to 18-months
30-second Chair Stand
Time frame: Change from baseline to 24-months
2-minute Step Test
Time frame: Change from baseline to 3-months
2-minute Step Test
Time frame: Change from baseline to 12-months (primary outcome time point)
2-minute Step Test
Time frame: Change from baseline to 18-months
2-minute Step Test
Time frame: Change from baseline to 24-months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale
Time frame: Change from baseline to 3-months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale
Time frame: Change from baseline to 12-months (primary outcome time point)
Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale
Time frame: Change from baseline to 18-months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale
Time frame: Change from baseline to 24-months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score
Time frame: Change from baseline to 3-months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score
Time frame: Change from baseline to 12-months (primary outcome time point)
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score
Time frame: Change from baseline to 18-months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score
Time frame: Change from baseline to 24-months
Average Step Count
Time frame: Baseline
Average Step Count
Time frame: Change from baseline to 12-months (primary outcome time point)
Average Step Count
Time frame: Change from baseline to 24-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset will be available upon request, as allowable under the regulations and policies of study sponsors. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format. Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication. No data or statistical code that could lead to re-identification of individuals will be released. Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re-identify any individual whose data are included in the dataset
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelli Dominick Allen, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual PT Care (UC) and BOOST-OA in people with Osteoarthritis, Knee, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelli D Allen, PhD ((919) 286-0411 ext. 7090, kelli.allen@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.