Expanding Exercise Programming for Veterans Through Telehealth

Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05666167
• Other study ID #: CDX 22-008
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: March 31, 2027

Study information

• Verified date: March 2024
• Source: VA Office of Research and Development
• Contact: Lauren Abbate, MD
• Phone: (303) 399-8020
• Email: Lauren.Abbate[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis

Intervention

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.

Locations

Country	Name	City	State
United States	Rocky Mountain Regional VA Medical Center, Aurora, CO	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Change in Arm Curls	The number of curls performed in 30 seconds. Higher scores indicate higher function.	Baseline, 3 months, 9 months
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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.