Status:
COMPLETED
Vivo Heart: Home-Based Virtual Exercise Program for Older Adults With Cardiovascular Disease
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
60-80 years
Phase:
NA
Brief Summary
This pilot study will assess the feasibility and generate preliminary efficacy data of a novel, synchronous, home-based exercise training program for rural older adults with cardiovascular disease (CV...
Eligibility Criteria
Inclusion
- 60 - 80 years
- Lives in a rural area based on established urban-rural definitions (e.g., RUCA codes, RUCC, UIC)
- A qualifying Cardio Vascular Disease (CVD) event or procedure
- Cognitively unimpaired Telephone Interview for Cognitive Status (TICS-m ≥32)
- No major depressive symptoms Patient Health Questionnaire (PHQ-8 \<10)
- Ambulatory and community-dwelling
- Less than 150 min per week of moderate-to-intensive aerobic or resistance exercise in the past month
- Medically cleared for exercise if event was within the last 6 months
- Access to a tablet or computer and internet/Wi-Fi in defined exercise space
- Able to provide own transportation to study visits
- Not participating in a clinical trial
- Willing to provide informed consent
Exclusion
- \<60 years or \>80 years
- Lives in non-rural area
- No CVD or a qualifying event or procedure
- Dementia or severe cognitive impairment (TICS-m \<32)
- Clinical depression (PHQ-8 ≥10)
- Non-ambulatory, institutionalized, or requires walker
- Regular aerobic or resistance exercise (including current participation in a cardiac rehab program)
- Not medically cleared for exercise
- Advanced kidney disease requiring dialysis or dialysis anticipated within 6 months
- Insulin-dependent diabetes
- Use of any supplemental oxygen for COPD
- Significant impairment from a prior stroke
- Progressive neurologic disease (Parkinson's, ALS, multiple sclerosis, Alzheimer's disease, dementia)
- Severe arthritis, fracture, chronic injury, or other musculoskeletal disorder that prevents walking independently
- Cancer (not including non-melanoma skin cancers) requiring treatment with the past year
- Excessive alcohol consumption (\>7/week alcoholic beverages for women and \>14/week for men) in the past month
- Joint replacement or other orthopedic surgery in past 12 months or planned in next 6 months
- No computer, tablet or internet access
- No access to transportation for travel to study visits
- Current participation in a clinical trial
- Inability or unwillingness to comply with the study requirements
Key Trial Info
Start Date :
March 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2025
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05972850
Start Date
March 19 2024
End Date
May 16 2025
Last Update
June 4 2025
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157