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Telehealth Exercise Program for Arthritis
N/A
Recruiting
Led By Lauren Abbate, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months, 9 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will evaluate the feasibility & acceptability of group telehealth exercise to treat lower extremity OA in Veterans over 9 months. Outcomes will measure changes in WOMAC, performance & physical activity.
Who is the study for?
This trial is for Veterans with knee or hip arthritis who are patients at Eastern Colorado Healthcare System, haven't been active lately, and have had a VA visit in the past year. It's not for those without phone access, recent serious health events, current participation in similar studies, or conditions that would limit joining group exercises.
What is being tested?
The study tests a telehealth exercise program for Veterans with arthritis over 9 months. Participants will do group exercises via telehealth for 3 months followed by text message support or additional booster sessions to maintain exercise habits.
What are the potential side effects?
Since this is an exercise-based intervention conducted remotely, side effects may include typical exercise-related issues such as muscle soreness or strain but should be minimal given the focus on individuals with osteoarthritis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months, 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months, 9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Referrals
Number of sessions attended
Recruitment
Secondary study objectives
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scores
Other study objectives
Change in 2-minute Step Test
Change in 30-second chair stand test
Change in Accelerometry Data
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise Initiation and Maintenance with Text Messaging and Booster SessionsExperimental Treatment1 Intervention
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.
Group II: Exercise Initiation and Maintenance with Text Messaging aloneActive Control1 Intervention
Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging alone.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,547 Total Patients Enrolled
7 Trials studying Arthritis
2,166 Patients Enrolled for Arthritis
Lauren Abbate, MDPrincipal InvestigatorRocky Mountain Regional VA Medical Center, Aurora, CO
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't seen a primary care doctor in the last year.I have had hip or knee surgery, or a recent severe knee injury.I was recently hospitalized for a heart or stroke-related event.I have a motor neuron disease.I do not speak English.I have been diagnosed with painful knee or hip arthritis.I have severe problems with my hearing, vision, or speech.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise Initiation and Maintenance with Text Messaging and Booster Sessions
- Group 2: Exercise Initiation and Maintenance with Text Messaging alone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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