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Completed

NCT Number: NCT06522906

Mobilizing Hispanics With Knee Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Banner University Medical Center

Tucson, Arizona, 85713, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Muscle Strengthening

Behavioral

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.

General physical activity

Behavioral

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.

Education

Behavioral

Administered by a promotora, treatment will include 4 live video educational sessions about OA

Primary outcomes

  1. Educational sessions attended

    Time frame: 3 month follow-up

    Number of educational sessions attended by patients and partners will be recorded

  2. Adherence with muscle strengthening program

    Time frame: 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)".

  3. Adherence with physical activity plan

    Time frame: 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".

  4. Satisfaction with program

    Time frame: 3 month follow-up

    Satisfaction with the program/s, using a 7-point numerical rating scale (1="extremely unsatisfied", 7="extremely satisfied")

  5. Perceived helpfulness

    Time frame: 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)

Secondary outcomes

  1. Osteoarthritis disease severity

    Time frame: 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.

  2. Physical activity

    Time frame: 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.

  3. Physical activity (self-report)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • Temple University
  • University of Melbourne

Registry information

Official study title

Mobilizing Hispanics With Knee Osteoarthritis Using a Dyad-based Approach: Pilot Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2024
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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