Mobilizing Hispanics With Knee Osteoarthritis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Behavioral: Muscle Strengthening; Behavioral: General Physical Activity; Behavioral: Education

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
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jazmin Dagnino; Phone Number: (520) 621-6823; Email: jazmindagnino@arizona.edu
• Study Contact Backup: Name: Ernest Vina, MD; Phone Number: (520) 626-1613; Email: evina@arizona.edu

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85713
      • Recruiting
      • Banner University Medical Center
      • Principal Investigator: Ernest Vina, MD
      • Contact: Jazmin Dagnino; Phone Number: (520) 626-5026; Email: jazmindagnino@arizona.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.; 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.; Behavioral: Education; Administered by a promotora, treatment will include 4 live video educational sessions about OA
Active Comparator: Control; Treatment only includes live video educational sessions about OA	Behavioral: Education; Administered by a promotora, treatment will include 4 live video educational sessions about OA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osteoarthritis disease severity	Severity of OA symptoms will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Change in two subscale scores (joint pain [primary outcome, range 0-20] and physical function [0-68]) will be calculated.	Baseline and 3 month follow-up
Physical activity	Physical activity will be measured using a pedometer. Participants will be asked to wear a pedometer at the waist for 7 consecutive days to record the number of steps taken per day.	Baseline and 3 month follow-up
Physical activity (self-report)	Physical activity (self-report) of study dyads in the last week will also be measured using the Physical Activity Scale for the Elderly (range: 0-400, higher scores indicate greater physical activity	Baseline and 3 month follow-up

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: Temple University; University of Melbourne
• Investigators: Principal Investigator: Ernest Vina, MD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Hispanic
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Behavior; Osteoarthritis, Knee; Motor Activity; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: 00004081; 991639 (Other Grant/Funding Number: Rheumatology Research Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No