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

July 10, 2026 updated by: Wake Forest University Health Sciences
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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).
Behavioral: 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.
Other Names:
  • Vivo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Completion Rate
Time Frame: Week 12
Completion rate will be determined by the percentage of enrolled participants who complete the exercise and nutrition classes with ≥80% compliance.
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Year 1
Retention Rate
Time Frame: Week 12
Retention will be determined by the percentage of enrolled participations who complete follow-up testing.
Week 12
Recruitment Yield
Time Frame: Year 1
Recruitment yield will be determined based on the number of participants randomized relative to the total number of recruitment letters sent to potentially eligible participants
Year 1
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 and nutrition classes.
Week 12
Number of Participants Satisfied With Intervention
Time Frame: Week 12
Acceptability will be assessed at the end of the study using a program satisfaction survey.
Week 12
Continuation Rate
Time Frame: Year 1
Continuation rate will be determined by the number of participants who continue in the Vivo program after the study is over.
Year 1

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment (MoCA)
Time Frame: Week 12
Change in overall cognition (0-30)
Week 12
Digit Symbol Coding (DSC)
Time Frame: Week 12
Change in processing speed, working memory, visuospatial processing, and attention (secs)
Week 12
Timed Up and Go (TUG)
Time Frame: Week 12
Change in time to complete (secs)
Week 12
Expanded Short Physical Performance Battery (eSPPB)
Time Frame: Week 12
Change in score (0-4)
Week 12
The Four Square Step Test (FSST)
Time Frame: Week 12
Change in time to complete (secs)
Week 12
4-step Stair Climb Test (4SCT)
Time Frame: Week 12
Change in time to complete (secs)
Week 12
Grip Strength
Time Frame: Week 12
Change in grip strength (kg)
Week 12
Perceived Stress Scale (PSS)
Time Frame: Week 12
Change in score
Week 12
Short Form-36 Health Survey (SF-36)
Time Frame: Week 12
Change in score
Week 12
UCLA Loneliness Scale
Time Frame: Week 12
Change in score
Week 12
Life Space
Time Frame: Week 12
Change in score
Week 12
Pittsburgh Fatigability Scale (PFS)
Time Frame: Week 12
Change in score
Week 12
VO2 Peak
Time Frame: Week 12
Change in VO2 peak
Week 12
Blood Pressure
Time Frame: Week 12
Change in systolic and diastolic blood pressure (mmHg)
Week 12
Heart Rate
Time Frame: Week 12
Change in resting heart rate (bpm)
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tina E Brinkley, PhD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00094007
  • P30AG021332 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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