RecruitingNot ApplicableNCT06522906

Mobilizing Hispanics With Knee Osteoarthritis

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


Sponsor

University of Arizona

Enrollment

44 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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)

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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


Locations(1)

Banner University Medical Center

Tucson, Arizona, United States

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NCT06522906


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