Vivo Heart: Home-Based Virtual Exercise Program for Older Adults With Cardiovascular Disease

Wake Forest University (WFU)

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Behavioral: Vivo Heart

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05972850

P30AG021332 (U.S. NIH Grant/Contract)

IRB00094007

Details and patient eligibility

About

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 (CVD) using Vivo, an online, live, small group fitness program developed for older adults. It uses individually tailored dual-tasked (i.e., cognitive-motor) exercises to improve strength, endurance, balance, and cognition and incorporates social engagement. Certified trainers deliver instruction and coaching through an interactive session (45 min, 2-3 times/week) delivered over 12 weeks. Vivo Heart adapts this unique program to meet the cardiac rehabilitation needs of older adults with CVD. The specific aims are to evaluate the feasibility, acceptability, and uptake of Vivo Heart (Aim 1) and obtain pre- and post-intervention measures of exercise capacity, strength, lower-extremity physical function, cognition, quality of life, stress, fatigability, physical activity, and aging biomarkers (Aim 2).

Enrollment: 27 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• <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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Vivo Heart

Experimental group

Description:

This virtual intervention will include weekly group exercise sessions with a Vivo trainer (2 times/week), weekly health education classes with a registered dietitian (RD) (1 time/week), and two individual meetings with the RD over the course of 12 weeks. Participants will also be asked to complete a weekly aerobic exercise session on their own (1 time/week).

Treatment:

Behavioral: Vivo Heart