Mobilizing Hispanics With Knee Osteoarthritis
NCT Number: NCT06522906
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoarthritis, Knee
Interventions: BEHAVIORAL: Muscle Strengthening|BEHAVIORAL: General Physical Activity|BEHAVIORAL: Education
Sponsor: University of Arizona
Collaborators: Temple University|University of Melbourne
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-06-30

Summary:
The objective is to conduct an early-stage clinical trial in order to provide data required to support a future clinical trial to demonstrate the effectiveness of a culturally acceptable treatment program to increase exercise and regular physical activity among Hispanics with knee osteoarthritis (OA).

Hispanic patients with knee OA paired with a chosen family member/close friend will be recruited for study participation. A pilot randomized controlled trial will be conducted. Study pairs will be randomized to receive either: 1) an intervention that will be administered by live video consultations and will include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving study pairs; or 2) a control treatment that only includes live video educational sessions about OA.

Study participants will fill out a survey before the start of the study and 3 months after.

Primary Outcome Measures: Educational sessions attended, Number of educational sessions attended by patients and partners will be recorded, 3 month follow-up|Adherence with muscle strengthening program, Intervention group only. Patients will rate how much they agree/disagree (11-point numerical rating scale) with the statement: "I have been doing my exercises exactly as I was asked by my physical therapist (# sessions, exercises and repetitions)"., 3 month follow-up|Adherence with physical activity plan, Intervention group only. Study dyads will rate how much they agree/disagree in an 11-point numerical rating scale with the statement: "I followed the physical activity plan that my promotora helped me develop"., 3 month follow-up|Satisfaction with program, Satisfaction with the program/s, using a 7-point numerical rating scale (1="extremely unsatisfied", 7="extremely satisfied"), 3 month follow-up|Perceived helpfulness, Perceived helpfulness of the program/s in improving OA symptoms, increasing physical activity and improving communication with their chosen partner, and the likelihood of recommending the program to OA patients and their partners, using a 5-point numerical rating scale (1=not at all/definitely would not, 5=extremely/definitely would not), 3 month follow-up
Secondary Outcome Measures: Osteoarthritis disease severity, Severity of OA symptoms will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Change in two subscale scores (joint pain \[primary outcome, range 0-20\] and physical function \[0-68\]) will be calculated., Baseline and 3 month follow-up|Physical activity, Physical activity will be measured using a pedometer. Participants will be asked to wear a pedometer at the waist for 7 consecutive days to record the number of steps taken per day., Baseline and 3 month follow-up|Physical activity (self-report), Physical activity (self-report) of study dyads in the last week will also be measured using the Physical Activity Scale for the Elderly (range: 0-400, higher scores indicate greater physical activity, Baseline and 3 month follow-up