Boosting Exercise Adherence in Knee Osteoarthritis

Part of paid clinical trials in Durham, North Carolina.

Sponsor
VA Office of Research and Development
Study ID
NCT07219732
Status
Not Yet Recruiting

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Conditions

  • Osteoarthritis, Knee

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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).

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Oct 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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 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.
  • Experimental: BOOST-OA
    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 Outcome Measure

Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Durham VA Medical Center, Durham, NCDurhamNorth Carolina27705-3875
Susanna B Oberg, AAS AAS
[email protected]
(615) 873-6955
Heidi D Bassani
[email protected]
(919) 286-0411
Kelli Dominick Allen, PhD (PRINCIPAL_INVESTIGATOR)

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