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

NCT05972850 | Completed DMC

• 2 other identifiers: IRB00094007P30AG021332
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Keywords

home-based cardiac rehabilitation; mobile health technologies; strength and physical function; synchronous virtual exercise program

Outcome Measures

Primary Outcomes (1)

• Completion Rate

  Completion rate which will be determined by the percentage of enrolled participants who complete the study with ≥80% compliance.

  Week 12

Secondary Outcomes (6)

• Recruitment Rate

  Year 1

• Recruitment Yield

  Year 1

• Compliance Rate

  Week 12

• Retention Rate

  Week 12

• Satisfaction Survey Scores

  Week 12

Other Outcomes (15)

• VO2 peak

  Week 12

• Montreal Cognitive Assessment (MoCA)

  Week 12

• Digit Symbol Coding (DSC)

  Week 12

Study Arms (1)

Vivo Heart

EXPERIMENTAL

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).

Behavioral: Vivo Heart

Interventions

Vivo Heart 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.

Also known as: Vivo

Vivo Heart

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Tina E Brinkley, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 40 rural-living older adults (60-80 years) with a history of cardiovascular disease (prior myocardial infarction, angina, or coronary procedure) who are medically cleared for exercise by their cardiologist.

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: March 19, 2024
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)