Osteoarthritis, Knee
Conditions
Keywords
Hispanic, Exercise
Brief 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.
Detailed description
Feasibility of the intervention will be based on the number of study pairs that will be recruited during the study and on attendance to the intervention sessions, and acceptability will be based on quantitative acceptability (e.g., program satisfaction) and qualitative measures.
Interventions
BEHAVIORALMuscle Strengthening
Patients will be offered five video consultations (30-45 minutes each) with a physical therapist over 3 months. The physical therapist will prescribe an exercise program individualized to the OA patient that will include strengthening exercises (2 quadriceps, 1 hip/gluteal, 1 hamstrings/gluteal, 1 calf, and 1 other) to be performed at home 3x/week.
BEHAVIORALGeneral Physical Activity
The general program will consist of four 60-minute live video consultations conducted by a promotora. The first three sessions will be conducted every 2 weeks, with a booster session occurring one month later. The promotora will help dyads set achievable personalized physical activity goals.
BEHAVIORALEducation
Administered by a promotora, treatment will include 4 live video educational sessions about OA
Sponsors
Temple University
University of Melbourne
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Hispanic/Latino ethnicity * ≥ 50 years of age * Access to a device with internet connection * Chronic, frequent knee pain (National Health and Nutrition Examination Survey criteria) * Meet American College of Rheumatology criteria for knee OA WOMAC pain score of ≥4 and at least moderate pain (score 2) for at least 2 questions
Exclusion criteria
* Unknown or non-Hispanic ethnicity * Condition that prevents ability to provide consent * Illness with a life expectancy \<12 months * History of arthroplasty or prosthetic leg * Inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus erythematosus, gout) * Condition that prevents exercise or physical activity (e.g., unstable cardiovascular disease)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived helpfulness | 3 month follow-up | 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) |
| Adherence with muscle strengthening program | 3 month follow-up | 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). |
| Adherence with physical activity plan | 3 month follow-up | 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. |
| Satisfaction with program | 3 month follow-up | Satisfaction with the program/s, using a 7-point numerical rating scale (1=extremely unsatisfied, 7=extremely satisfied) |
| Educational sessions attended | 3 month follow-up | Number of educational sessions attended by patients and partners will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Osteoarthritis disease severity | Baseline and 3 month follow-up | 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. |
| Physical activity (self-report) | Baseline and 3 month follow-up | 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 |
| Physical activity | Baseline and 3 month follow-up | 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. |
Countries
United States
Contacts
Primary ContactJazmin Dagnino
Backup ContactErnest Vina, MD
Outcome results
None listed