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NCT07219732
Boosting Exercise Adherence in Knee Osteoarthritis
Conditions: Osteoarthritis, Knee
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 360
Sponsor: VA Office of Research and Development
Location: Durham VA Medical Center, Durham, NC Durham North Carolina
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.
Eligibility Criteria
Inclusion Criteria:
1. Diagnosis of knee osteoarthritis (verified from the Electronic Health Record)
2. Knee pain for 3 months
3. Knee pain on most days of the previous month,
4. Average knee pain 3 (on a scale of 0-10),
5. Self-report of some difficulty with walking or stair climbing.
Exclusion Criteria:
1. Systemic rheumatic conditions, fibromyalgia, gout (knee)
2. Dementia, psychosis or active substance abuse disorder
3. Meniscus or knee ligament tear in the past 6 months
4. Lower extremity surgery in past 6 months or planned in next 9 months
5. Severe hearing or visual impairment
6. Serious / terminal illness
7. Hospitalization for a cardiovascular event, past 3 months
8. Unstable angina
9. History of ventricular tachycardia
10. Unstable chronic obstructive pulmonary disease
11. Uncontrolled hypertension (diastolic \>110 millimeters of mercury (mm/Hg) or systolic \> 200mm/Hg)
12. Stroke with moderate to severe aphasia
13. History of three or more falls in past 6 months
14. Resident of a long-term care facility
15. Other health problem that would prohibit safe participation in the study or home exercise
16. Current participation in another OA intervention study
17. Currently meeting Department of Health and Human Services physical activity recommendations
18. Completed physical therapy (PT) for knee OA in the past year
19. Unable to speak sufficient English to participate in study activities
Source: ClinicalTrials.gov (NCT07219732). StuddyBuddy aggregates publicly available trial information.