Expanding Exercise Programming for Veterans Through Telehealth

Expanding Exercise Programming for Veterans Through Telehealth (CDA 22-066)

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.

Study Overview

• Status: Recruiting
• Conditions: Arthritis
• Intervention / Treatment: Behavioral: Group Telehealth Exercise Sessions with text messaging plus booster sessions

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Abbate, MD; Phone Number: 3177 (303) 399-8020; Email: Lauren.Abbate@va.gov
• Study Contact Backup: Name: Andrew T Stephens; Phone Number: (720) 723-6726; Email: Andrew.Stephens1@va.gov

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045-7211
      • Recruiting
      • Rocky Mountain Regional VA Medical Center, Aurora, CO
      • Contact: Lauren Abbate, MD; Phone Number: 3177 (303) 399-8020; Email: Lauren.Abbate@va.gov
      • Principal Investigator: Lauren Abbate, MD
      • Contact: Andrew T Stephens; Phone Number: (720) 723-6726; Email: Andrew.Stephens1@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Initiation and Maintenance with Text Messaging and 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.	Behavioral: 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.
Active Comparator: Exercise Initiation and Maintenance with Text Messaging alone; Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging alone.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Referrals	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.	3 months
Number of sessions attended	The number of sessions attended as a percentage of the number offered will be gathered as a measure of feasibility and acceptability.	3 months
Recruitment	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scores	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.	Baseline, 3 months, 6 months, and 9 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 30-second chair stand test	Number of times participant can rise from sitting in a chair in 30 seconds. Higher scores indicate higher function.	Baseline, 3 months, 9 months
Change in 2-minute Step Test	The number of steps in place (right knee to midpoint of upper leg = 1 step) in 2 minutes. Higher scores indicate higher function.	baseline, 3 months, 9 months
Change in Arm Curls	The number of curls performed in 30 seconds. Higher scores indicate higher function.	Baseline, 3 months, 9 months
Change in Accelerometry Data	Gathered using an ActiGraph worn on wrist for 7 consecutive days. Specifically step changes in step counts. Larger increases indicate increased physical activity.	Baseline, 3 months, 6 months, 9 months
Change in Number of Steps assessed by Pedometer	Daily steps recorded by Veteran in AnnieApp text message reply and in daily exercise logs. Larger increases indicate increased physical activity.	Baseline, 3 months, 6 months, 9 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Lauren Abbate, MD, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: osteoarthritis; text messaging; telehealth; group exercise; exercise maintenance
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: CDX 22-008

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