Expanding Exercise Programming for Veterans Through Telehealth

NCT ID: NCT05666167

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2027-03-31

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.

Conditions

Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Group Telehealth Exercise Sessions with text messaging plus booster sessions

Intervention Type: BEHAVIORAL

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

Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging alone.

Group Type: ACTIVE_COMPARATOR

Group Telehealth Exercise Sessions with text messaging plus booster sessions

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren Abbate, MD

Role: PRINCIPAL_INVESTIGATOR

Rocky Mountain Regional VA Medical Center, Aurora, CO

Locations

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lauren Abbate, MD

Role: CONTACT

Lauren.Abbate@va.gov

(303) 399-8020 ext. 3177

Andrew T Stephens

Role: CONTACT

Andrew.Stephens1@va.gov

(720) 723-6726

Facility Contacts

Lauren Abbate, MD

Role: primary

Lauren.Abbate@va.gov

303-399-8020 ext. 3177

Andrew T Stephens

Role: backup

Andrew.Stephens1@va.gov

(720) 723-6726

Other Identifiers

CDX 22-008

Identifier Type: -

Identifier Source: org_study_id