Expanding Exercise Programming for Veterans Through Telehealth

Not Applicable

Recruiting

• Conditions: Arthritis
• Interventions: Behavioral: Group Telehealth Exercise Sessions with text messaging plus booster sessions

• Registration Number: NCT05666167
• Lead Sponsor: VA Office of Research and Development

Brief Summary

The goal of this study is to evaluate the acceptability and feasibility of a group telehealth exercise program for Veterans with lower extremity osteoarthritis (OA). Methods: This is a randomized pilot trial where Veterans (n=50) receive a group telehealth exercise program (3 months), followed by an exercise maintenance phase (6 months) that includes either text messaging alone or text messaging plus group telehealth exercise booster sessions. The primary outcomes for this study are feasibility and acceptability of the intervention. Feasibility will be assessed through number and source of referrals, recruitment, and retention. Acceptability will be assessed through surveys and interviews for participants and providers addressing reasons for participation, satisfaction, perceived appropriateness, and overall experience containing Likert scales and both yes/no and open-ended questions. Exploratory outcomes, assessed at multiple time points during the course of the study, will measure changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and changes in performance measure and physical activity assessed remotely through individual telehealth sessions. Data will be collected at baseline, 3-, 6-, and 9-month follow-up.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-27
• Study Start: 2023-04-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07
• Primary Completion: 2026-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• diagnosis of symptomatic knee or hip OA
• Veterans at Eastern Colorado Healthcare System Primary Care Clinics with at least one VA visit within the past year
• physically inactive (add definition)

Exclusion Criteria

• No telephone access
• hip or knee surgery or acute meniscus or anterior cruciate ligament tear in the past six months
• recent hospitalization for cardiovascular/cerebrovascular event
• serious mental health condition or behavioral issues precluding participating in group exercise
• terminal illness
• motor neuron diseases
• severely impaired hearing, vision, or speech
• non-English speaking
• current participation in another OA or exercise intervention or lifestyle change study
• other self-reported or study team/primary care physician deemed health condition that would prohibit participation in the study
• no primary care physician visit in past 12 months
• pregnant women
• insufficient internet connectivity to participate in group telehealth

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Initiation and Maintenance with Text Messaging and Booster Sessions	Group Telehealth Exercise Sessions with text messaging plus booster sessions	Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging plus monthly group telehealth exercise booster sessions.
Exercise Initiation and Maintenance with Text Messaging alone	Group Telehealth Exercise Sessions with text messaging plus booster sessions	Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging alone.

Primary Outcome Measures

Name	Time	Method
Recruitment	3 months	The goal is that 50% of eligible provider and self-referrals and 25% of chart review referrals will participate in the program as a measure of success.
Number of sessions attended	3 months	The number of sessions attended as a percentage of the number offered will be gathered as a measure of feasibility and acceptability.
Number of Referrals	3 months	The number of referrals made by providers, through chart review, and the number of self-referrals by Veterans will be collected as a measure of feasibility.

Secondary Outcome Measures

Name	Time	Method
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scores	Baseline, 3 months, 6 months, and 9 months.	Changes in lower extremity pain (5 items), stiffness (2 items), and function (17 items) assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale scores. Each item is scored on a Likert scale ranging from 0 to 4 (none, mild, moderate, severe, and extreme). Scores range from 0-96 and higher scores are generally associated with worse outcomes.

Trial Locations

Locations (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO; 🇺🇸 Aurora, Colorado, United States