Clinical trial NCT05666167: Expanding Exercise Programming for Veterans Through Telehealth
Official title: Expanding Exercise Programming for Veterans Through Telehealth (CDA 22-066)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthritis
Keywords: osteoarthritis
exercise maintenance
telehealth
group exercise
text messaging
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-12-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Number of Referrals
timeFrame: 3 months
measure: Number of sessions attended
timeFrame: 3 months
measure: Recruitment
timeFrame: 3 months
Secondary outcomes:
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scores
timeFrame: Baseline, 3 months, 6 months, and 9 months.
Other outcomes:
measure: Change in 30-second chair stand test
timeFrame: Baseline, 3 months, 9 months
measure: Change in 2-minute Step Test
timeFrame: baseline, 3 months, 9 months
measure: Change in Arm Curls
timeFrame: Baseline, 3 months, 9 months
measure: Change in Accelerometry Data
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Change in Number of Steps assessed by Pedometer
timeFrame: Baseline, 3 months, 6 months, 9 months
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Lauren Abbate, MD
role: PRINCIPAL_INVESTIGATOR
References: