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CompletedNCT05972850Updated Sep 11, 2026Results posted

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

An interventional study of Vivo Heart in Cardiovascular Disease, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
60 Years to 80 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Cardiovascular Disease

Keywords

  • home-based cardiac rehabilitation
  • mobile health technologies
  • strength and physical function
  • synchronous virtual exercise program
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 28 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralVivo 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.

    Also known as: Vivo

06

What researchers measure

Primary outcomes

  1. Completion Rate

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

    Time frame: Week 12

Secondary outcomes

  1. Recruitment Rate

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

    Time frame: Year 1

  2. 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

    Time frame: Year 1

  3. Compliance Rate

    Compliance will be determined based on adherence to the prescribed intervention. Compliance metrics will include attendance at the exercise and nutrition classes.

    Time frame: Week 12

  4. Retention Rate

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

    Time frame: Week 12

  5. Number of Participants Satisfied With Intervention

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

    Time frame: Week 12

  6. Continuation Rate

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

    Time frame: Year 1

Other outcomes

  1. VO2 Peak

    Change in VO2 peak

    Time frame: Week 12

  2. Montreal Cognitive Assessment (MoCA)

    Change in overall cognition (0-30)

    Time frame: Week 12

  3. Digit Symbol Coding (DSC)

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

    Time frame: Week 12

  4. Timed Up and Go (TUG)

    Change in time to complete (secs)

    Time frame: Week 12

  5. Expanded Short Physical Performance Battery (eSPPB)

    Change in score (0-4)

    Time frame: Week 12

  6. The Four Square Step Test (FSST)

    Change in time to complete (secs)

    Time frame: Week 12

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

    Change in time to complete (secs)

    Time frame: Week 12

  8. Grip Strength

    Change in grip strength (kg)

    Time frame: Week 12

  9. Perceived Stress Scale (PSS)

    Change in score

    Time frame: Week 12

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

    Change in score

    Time frame: Week 12

  11. UCLA Loneliness Scale

    Change in score

    Time frame: Week 12

  12. Life Space

    Change in score

    Time frame: Week 12

  13. Pittsburgh Fatigability Scale (PFS)

    Change in score

    Time frame: Week 12

  14. Blood Pressure

    Change in systolic and diastolic blood pressure (mmHg)

    Time frame: Week 12

  15. Heart Rate

    Change in resting heart rate (bpm)

    Time frame: Week 12

07

Results

Posted Aug 4, 2026

Participant flow

Participant flow — Overall Study
MilestoneVivo Heart
Started28
Completed25
Not completed3
Withdrew: Withdrawal by subject1
Withdrew: Lost to follow-up1
Withdrew: Did not start intervention due to developing health issues1

Outcome measures

PrimaryCompletion Rate

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

Time frame:
Week 12
Reported as:
Count of participants · Participants
Completion Rate
ParticipantsVivo Heart
completed at least 80% of exercise session14
completed at least 80% of nutrition classes17
completed at least 80% of both exercise and nutrition classes12
SecondaryRecruitment Rate

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

Time frame:
Year 1
Reported as:
Number · participants per month
Recruitment Rate
participants per monthVivo Heart
Recruitment Rate2.3
SecondaryRecruitment 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

Time frame:
Year 1
Reported as:
Number · % of eligible participants recruited
Recruitment Yield
% of eligible participants recruitedVivo Heart
Recruitment Yield4.1
SecondaryCompliance Rate

Compliance will be determined based on adherence to the prescribed intervention. Compliance metrics will include attendance at the exercise and nutrition classes.

Time frame:
Week 12
Reported as:
Mean · percentage
Compliance Rate
percentageVivo Heart
Exercise classes attended75 ± 20
Nutrition classes attended78 ± 26
SecondaryRetention Rate

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

Time frame:
Week 12
Reported as:
Count of participants · Participants
Retention Rate
ParticipantsVivo Heart
Retention Rate25
SecondaryNumber of Participants Satisfied With Intervention

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

Time frame:
Week 12
Reported as:
Count of participants · Participants
Number of Participants Satisfied With Intervention
ParticipantsVivo Heart
Number of Participants Satisfied With Intervention25
SecondaryContinuation Rate

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

Time frame:
Year 1
Reported as:
Count of participants · Participants
Continuation Rate
ParticipantsVivo Heart
Continuation Rate3
Other pre-specifiedVO2 Peak

Change in VO2 peak

Time frame:
Week 12

Results for this outcome have not been posted.

Other pre-specifiedMontreal Cognitive Assessment (MoCA)

Change in overall cognition (0-30)

Time frame:
Week 12

Results for this outcome have not been posted.

Other pre-specifiedDigit Symbol Coding (DSC)

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

Time frame:
Week 12

Results for this outcome have not been posted.

Other pre-specifiedTimed Up and Go (TUG)

Change in time to complete (secs)

Time frame:
Week 12

Results for this outcome have not been posted.

Other pre-specifiedExpanded Short Physical Performance Battery (eSPPB)

Change in score (0-4)

Time frame:
Week 12

Results for this outcome have not been posted.

Other pre-specifiedThe Four Square Step Test (FSST)

Change in time to complete (secs)

Time frame:
Week 12

Results for this outcome have not been posted.

Other pre-specified4-step Stair Climb Test (4SCT)

Change in time to complete (secs)

Time frame:
Week 12

Results for this outcome have not been posted.

Other pre-specifiedGrip Strength

Change in grip strength (kg)

Time frame:
Week 12

Results for this outcome have not been posted.

Other pre-specifiedPerceived Stress Scale (PSS)

Change in score

Time frame:
Week 12

Results for this outcome have not been posted.

Other pre-specifiedShort Form-36 Health Survey (SF-36)

Change in score

Time frame:
Week 12

Results for this outcome have not been posted.

Other pre-specifiedUCLA Loneliness Scale

Change in score

Time frame:
Week 12

Results for this outcome have not been posted.

Other pre-specifiedLife Space

Change in score

Time frame:
Week 12

Results for this outcome have not been posted.

Other pre-specifiedPittsburgh Fatigability Scale (PFS)

Change in score

Time frame:
Week 12

Results for this outcome have not been posted.

Other pre-specifiedBlood Pressure

Change in systolic and diastolic blood pressure (mmHg)

Time frame:
Week 12

Results for this outcome have not been posted.

Other pre-specifiedHeart Rate

Change in resting heart rate (bpm)

Time frame:
Week 12

Results for this outcome have not been posted.

Adverse events

Collected over baseline through 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Vivo Heart0/27 (0%)0/27 (0%)10/27 (37%)
Most frequent other events
Showing 10 of 14
Most frequent other events
EventVivo Heart
sciaticaMusculoskeletal and connective tissue disorders2/27
reinjured low backMusculoskeletal and connective tissue disorders1/27
toenail fungusSkin and subcutaneous tissue disorders1/27
drug reactionImmune system disorders1/27
chest pain during exerciseCardiac disorders1/27
carpal tunnel surgeryNervous system disorders1/27
dyspneaRespiratory, thoracic and mediastinal disorders1/27
back strain from choresMusculoskeletal and connective tissue disorders1/27
knee pain from fallMusculoskeletal and connective tissue disorders1/27
chronic right shoulder painMusculoskeletal and connective tissue disorders1/27

Baseline characteristics

Age, Continuous
Age, Continuous(years)Vivo Heart
Mean66.7 ± 4.7
Sex: Female, Male
Sex: Female, Male(Participants)Vivo Heart
Female10
Male18
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Vivo Heart
Hispanic or Latino1
Not Hispanic or Latino27
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Vivo Heart
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White28
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 27, 2025
  • Informed consent form · Sep 23, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05972850
Lead sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
Aug 2, 2023
Start date
Mar 19, 2024
Primary completion
May 16, 2025
Completion
May 16, 2025
Results posted
Aug 4, 2026
Last update
Sep 11, 2026

Study contacts

Tina E Brinkley, PhD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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