Expanding Exercise Programming for Veterans Through Telehealth
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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.
Secondary Outcome Measures
- 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.
Other Outcome Measures
- Change in 30-second chair stand test [Baseline, 3 months, 9 months]
Number of times participant can rise from sitting in a chair in 30 seconds. Higher scores indicate higher function.
- Change in 2-minute Step Test [baseline, 3 months, 9 months]
The number of steps in place (right knee to midpoint of upper leg = 1 step) in 2 minutes. Higher scores indicate higher function.
- Change in Arm Curls [Baseline, 3 months, 9 months]
The number of curls performed in 30 seconds. Higher scores indicate higher function.
- Change in Accelerometry Data [Baseline, 3 months, 6 months, 9 months]
Gathered using an ActiGraph worn on wrist for 7 consecutive days. Specifically step changes in step counts. Larger increases indicate increased physical activity.
- Change in Number of Steps assessed by Pedometer [Baseline, 3 months, 6 months, 9 months]
Daily steps recorded by Veteran in AnnieApp text message reply and in daily exercise logs. Larger increases indicate increased physical activity.
Eligibility Criteria
Criteria
Inclusion Criteria:
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diagnosis of symptomatic knee or hip OA
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Veterans at Eastern Colorado Healthcare System Primary Care Clinics with at least one VA visit within the past year
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physically inactive (add definition)
Exclusion Criteria:
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No telephone access
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hip or knee surgery or acute meniscus or anterior cruciate ligament tear in the past six months
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recent hospitalization for cardiovascular/cerebrovascular event
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serious mental health condition or behavioral issues precluding participating in group exercise
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terminal illness
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motor neuron diseases
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severely impaired hearing, vision, or speech
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non-English speaking
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current participation in another OA or exercise intervention or lifestyle change study
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other self-reported or study team/primary care physician deemed health condition that would prohibit participation in the study
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no primary care physician visit in past 12 months
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pregnant women.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Lauren Abbate, MD, Rocky Mountain Regional VA Medical Center, Aurora, CO
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDX 22-008