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NCT06522906 | RECRUITING | Osteoarthritis, Knee


Mobilizing Hispanics With Knee Osteoarthritis
Sponsor:

University of Arizona

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.

Condition or disease

Osteoarthritis, Knee

Intervention/treatment

Muscle Strengthening

General Physical Activity

Education

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 44 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Mobilizing Hispanics With Knee Osteoarthritis Using a Dyad-based Approach: Pilot Randomized Controlled Trial
Actual Study Start Date : 2024-11-15
Estimated Primary Completion Date : 2025-11-30
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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)

Mobilizing Hispanics With Knee Osteoarthritis

Location Details

NCT06522906


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How to Participate

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Locations


RECRUITING

United States, Arizona

Banner University Medical Center

Tucson, arizona, United States, 85713

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