Expanding Exercise Programming for Veterans Through Telehealth
ConditionArthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of symptomatic knee or hip osteoarthritis (OA)
Veterans at Eastern Colorado Healthcare System Primary Care Clinics with at least one VA visit within the past year
physically inactive (add definition)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Group Telehealth Exercise Sessions with text messaging plus booster sessions
BehavioralParticipants 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Exercise Initiation and Maintenance with Text Messaging and Booster SessionsExperimental treatment 1 intervention
Group B: Exercise Initiation and Maintenance with Text Messaging aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months2
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.
Time frame
3 months3
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.
Time frame
3 monthsSecondary outcomes
1
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.
Time frame
Baseline, 3 months, 6 months, and 9 months.Other outcomes
1
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.
Time frame
Baseline, 3 months, 9 months2
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.
Time frame
baseline, 3 months, 9 months3
Change in Arm Curls
The number of curls performed in 30 seconds. Higher scores indicate higher function.
Time frame
Baseline, 3 months, 9 months4
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.
Time frame
Baseline, 3 months, 6 months, 9 monthsSponsors and contacts
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Source ClinicalTrials.gov