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

NCT ID: NCT05972850

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-19
• Study Completion Date: 2025-05-16

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 (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).

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Vivo Heart

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).

Group Type: EXPERIMENTAL

Vivo Heart

Intervention Type: BEHAVIORAL

Vivo is an online, live, small group fitness program developed for older adults that 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 for 45 min, 2-3 times/week.

Interventions

Vivo Heart

Vivo is an online, live, small group fitness program developed for older adults that 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 for 45 min, 2-3 times/week.

Intervention Type: BEHAVIORAL

Other Intervention Names

Vivo

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tina E Brinkley, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

P30AG021332

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00094007

Identifier Type: -

Identifier Source: org_study_id