Skip to main content
OpenTrials
Completed

NCT Number: NCT05972850

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Vivo

Primary outcomes

  1. Completion Rate

    Time frame: Week 12

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

Secondary outcomes

  1. Recruitment Rate

    Time frame: Year 1

    Recruitment rate will be determined by the total number of enrolled participants divided by the number of months recruitment occurred.

  2. Recruitment Yield

    Time frame: Year 1

    Recruitment yield will be determined based on the number of participants randomized relative to the total number of volunteers screened

  3. Compliance Rate

    Time frame: Week 12

    Compliance will be determined based on adherence to the prescribed intervention. Compliance metrics will include attendance at the exercise sessions, health education classes, and dietary counseling sessions.

  4. Retention Rate

    Time frame: Week 12

    Retention will be determined by the percentage of enrolled participations who complete follow-up testing.

  5. Satisfaction Survey Scores

    Time frame: Week 12

    Acceptability will be assessed at the end of the study using a program satisfaction survey.

  6. Continuation Rate

    Time frame: Year 1

    Uptake will be determined by the number of participants who continue in the Vivo program after the study is over.

Other outcomes

  1. VO2 peak

    Time frame: Week 12

    Change in VO2 peak

  2. Montreal Cognitive Assessment (MoCA)

    Time frame: Week 12

    Change in overall cognition (0-30)

  3. Digit Symbol Coding (DSC)

    Time frame: Week 12

    Change in processing speed, working memory, visuospatial processing, and attention (secs)

  4. Timed Up and Go (TUG)

    Time frame: Week 12

    Change in time to complete (secs)

  5. Expanded Short Physical Performance Battery (eSPPB)

    Time frame: Week 12

    Change in score (0-4)

  6. The Four Square Step Test (FSST)

    Time frame: Week 12

    Change in time to complete (secs)

  7. 4-step Stair Climb Test (4SCT)

    Time frame: Week 12

    Change in time to complete (secs)

  8. Grip Strength

    Time frame: Week 12

    Change in grip strength (kg)

  9. Perceived Stress Scale (PSS)

    Time frame: Week 12

    Change in score

  10. Short Form-36 Health Survey (SF-36)

    Time frame: Week 12

    Change in score

  11. UCLA Loneliness Scale

    Time frame: Week 12

    Change in score

  12. Life Space

    Time frame: Week 12

    Change in score

  13. Pittsburgh Fatigability Scale (PFS)

    Time frame: Week 12

    Change in score

  14. Blood pressure

    Time frame: Week 12

    Change in systolic and diastolic blood pressure (mmHg)

  15. Heart rate

    Time frame: Week 12

    Change in resting heart rate (bpm)

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 2, 2023
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.