Cardiovascular DiseaseNCT05972850

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

A study testing Vivo Heart in people with Cardiovascular Disease, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 to 80 years
Conditions the study is for: Cardiovascular Disease
What is being tested?: Vivo Heart
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 19 Mar 2024to 16 May 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 12Show fewer

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

Who cannot join

<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

Show all 21Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

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
Being tested: Vivo Heart
Keywords: home-based cardiac rehabilitation, mobile health technologies, strength and physical function, synchronous virtual exercise program
Medical subject headings: Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vivo HeartBehavioural
Also called Vivo
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.

Study groups in NCT05972850
Study group	Role	What they receive
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). Receives: Behavioral: Vivo Heart

What is being measured

The primary outcome is the main question the study is designed to answer.

Completion Rate
Completion rate will be determined by the percentage of enrolled participants who complete the exercise and nutrition classes with ≥80% compliance.
Measured: Week 12

Secondary outcomes (6)

Recruitment Rate
Recruitment rate will be determined by the total number of enrolled participants divided by the number of months recruitment occurred.
Measured: Year 1
Recruitment Yield
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
Measured: Year 1
Compliance Rate
Compliance will be determined based on adherence to the prescribed intervention. Compliance metrics will include attendance at the exercise and nutrition classes.
Measured: Week 12
Retention Rate
Retention will be determined by the percentage of enrolled participations who complete follow-up testing.
Measured: Week 12
Number of Participants Satisfied With Intervention
Acceptability will be assessed at the end of the study using a program satisfaction survey.
Measured: Week 12
Continuation Rate
Continuation rate will be determined by the number of participants who continue in the Vivo program after the study is over.
Measured: Year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 202416 May 2025

First posted2 Aug 2023
Study start19 Mar 2024
Primary completion16 May 2025
Study completion16 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05972850
Sponsor's protocol ID: IRB00094007
Other IDs: P30AG021332
Status last verified: Jul 2026
First submitted: 25 Jul 2023
Last updated: 11 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cardiovascular Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vivo Heart: Home-Based Virtual Exercise Program for Older Adults With Cardiovascular Disease
ClinicalTrials.gov ID: NCT05972850
Acronym / sponsor ID: IRB00094007
Conditions: Cardiovascular Disease
Keywords: home-based cardiac rehabilitation, mobile health technologies, strength and physical function, synchronous virtual exercise program
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 19 Mar 2024 (actual)
Primary completion: 16 May 2025 (actual)
Study completion: 16 May 2025 (actual)
First posted: 2 Aug 2023 (actual)
Results: Posted 4 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 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.

Arm	Type	Receives
Vivo Heart	Experimental	Behavioral: Vivo HeartThis 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).

Who may qualify

Ages: 60 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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)

Key exclusion criteria (21 listed)

<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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vivo HeartAlso: VivoVivo 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.	Behavioural	Vivo Heart

Primary outcome

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.

6 secondary outcomes

Recruitment Rate
Time frame: Year 1
Recruitment Yield
Time frame: Year 1
Compliance Rate
Time frame: Week 12
Retention Rate
Time frame: Week 12
Number of Participants Satisfied With Intervention
Time frame: Week 12
Continuation Rate
Time frame: Year 1

Results and safety

Results posted to the registry on 4 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vivo Heart	28	25

Primary outcome: Completion Rate

Time frame: Week 12. Count of participants. Unit: Participants

Measure	Vivo Heart n = 26
completed at least 80% of exercise session	14
completed at least 80% of nutrition classes	17
completed at least 80% of both exercise and nutrition classes	12

Population analysed: Out of the 28 participants enrolled, only 2 did not complete the 12-week intervention. Thus, we have intervention attendance data on 26 participants (the 25 who returned for follow-up testing plus one participant who completed the intervention but did not return for follow-up testing).

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: baseline through 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vivo Heart	0 of 27 (0%)	10 of 27 (37%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tina E Brinkley, PhD principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vivo Heart in people with Cardiovascular Disease, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion Rate (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05972850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.