Boosting Exercise Adherence in Knee Osteoarthritis

NCT07219732 | Not Yet Recruiting DMC

• 1 other identifier: RRD2-002-24W
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Osteoarthritis, Knee

Keywords

exercise, physical; physical therapy, health behavior

Outcome Measures

Primary Outcomes (5)

• 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).

  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).

  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).

  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).

  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).

  Change from baseline to 24-months

Secondary Outcomes (31)

• Patient Specific Functional Scale

  Baseline

• 30-second Chair Stand

  Baseline

• 2-minute Step Test

  Baseline

• WOMAC pain subscale

  Baseline

• WOMAC Total Score

  Baseline

Study Arms (2)

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 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.

Behavioral: Usual PT Care (UC)

BOOST-OA

EXPERIMENTAL

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).

Behavioral: BOOST-OA

Interventions

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.

Usual PT Care (UC)

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).

BOOST-OA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity; Health Behavior

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Officials

• Kelli Dominick Allen, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelli D Allen, PhD

CONTACT

(919) 286-0411; kelli.allen@va.gov

Jennifer M Gierisch, PhD MA

CONTACT

(919) 286-0411; jennifer.gierisch@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: VHA sites and participants will be notified of their randomization assignment by an unblinded study team. All participant assessments will be conducted by a study team member blinded to randomization assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 22, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Deidentified data will be made available after study completion and as allowable by current VA policies.
• Access Criteria: 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.

Locations

US (1)