Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
44 participants
INTERVENTIONAL
2024-11-15
2025-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention
Treatments include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving dyads
Muscle 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.
General 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.
Education
Administered by a promotora, treatment will include 4 live video educational sessions about OA
Control
Treatment only includes live video educational sessions about OA
Education
Administered by a promotora, treatment will include 4 live video educational sessions about OA
Interventions
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Muscle 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.
General 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.
Education
Administered by a promotora, treatment will include 4 live video educational sessions about OA
Eligibility Criteria
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Inclusion Criteria
* ≥ 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
* 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)
18 Years
90 Years
ALL
Yes
Sponsors
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Temple University
OTHER
University of Melbourne
OTHER
University of Arizona
OTHER
Responsible Party
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Principal Investigators
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Ernest Vina, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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Banner University Medical Center
Tucson, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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991639
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
00004081
Identifier Type: -
Identifier Source: org_study_id
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