Mobilizing Hispanics With Knee Osteoarthritis

NCT06522906 | Recruiting

• 2 other identifiers: 00004081991639
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Hispanic; Exercise

Outcome Measures

Primary Outcomes (5)

• Educational sessions attended

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

  3 month follow-up

• Adherence with muscle strengthening program

  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 month follow-up

• Adherence with physical activity plan

  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".

  3 month follow-up

• Satisfaction with program

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

  3 month follow-up

• Perceived helpfulness

  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)

  3 month follow-up

Secondary Outcomes (3)

• Osteoarthritis disease severity

  Baseline and 3 month follow-up

• Physical activity

  Baseline and 3 month follow-up

• Physical activity (self-report)

  Baseline and 3 month follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

Treatments include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving dyads

Behavioral: Muscle Strengthening; Behavioral: General Physical Activity; Behavioral: Education

Control

ACTIVE COMPARATOR

Treatment only includes live video educational sessions about OA

Behavioral: Education

Interventions

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.

Intervention

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.

Intervention

Education BEHAVIORAL

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

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Arizona: lead
• Temple University: collaborator
• University of Melbourne: collaborator

Study Sites (1)

Banner University Medical Center

Tucson, Arizona, 85713, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Ernest Vina, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jazmin Dagnino

CONTACT

(520) 621-6823; jazmindagnino@arizona.edu

Ernest Vina, MD

CONTACT

(520) 626-1613; evina@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: November 15, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)