Mobilizing Hispanics With Knee Osteoarthritis

NCT ID: NCT06522906

Last Updated: 2025-10-03

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

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

Group Type EXPERIMENTAL

Muscle Strengthening

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

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

Control

Treatment only includes live video educational sessions about OA

Group Type ACTIVE_COMPARATOR

Education

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Temple University

OTHER

Sponsor Role collaborator

University of Melbourne

OTHER

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jazmin Dagnino

Role: CONTACT

(520) 621-6823

Ernest Vina, MD

Role: CONTACT

(520) 626-1613

Facility Contacts

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Jazmin Dagnino

Role: primary

(520) 626-5026

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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