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NCT05666167 | Recruiting | Arthritis


Expanding Exercise Programming for Veterans Through Telehealth
Sponsor:

VA Office of Research and Development

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

Arthritis

Intervention/treatment

Group Telehealth Exercise Sessions with text messaging plus booster sessions

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 50 participants
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Expanding Exercise Programming for Veterans Through Telehealth (CDA 22-066)
Actual Study Start Date : April 1, 2023
Estimated Primary Completion Date : March 31, 2026
Estimated Study Completion Date : March 31, 2027
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

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

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.

Expanding Exercise Programming for Veterans Through Telehealth

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Expanding Exercise Programming for Veterans Through Telehealth

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Locations


Recruiting

United States, Colorado

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States, 80045

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