Trial Outcomes & Findings for Vivo Heart: Home-Based Virtual Exercise Program for Older Adults With Cardiovascular Disease (NCT NCT05972850)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

Week 12

Results posted on

2026-08-04

Participant Flow

Participant milestones

Participant milestones
Measure	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). 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.
Overall Study STARTED	28
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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). 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.
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	1
Overall Study Did not start intervention due to developing health issues	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vivo Heart n=28 Participants 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). 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.
Age, Continuous	66.7 years STANDARD_DEVIATION 4.7 • n=20 Participants
Sex: Female, Male Female	10 Participants n=20 Participants
Sex: Female, Male Male	18 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants
Race (NIH/OMB) White	28 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants

PRIMARY outcome

Timeframe: Week 12

Population: 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).

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

Outcome measures

Outcome measures
Measure	Vivo Heart n=26 Participants 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). 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.
Completion Rate completed at least 80% of exercise session	14 Participants
Completion Rate completed at least 80% of nutrition classes	17 Participants
Completion Rate completed at least 80% of both exercise and nutrition classes	12 Participants

SECONDARY outcome

Timeframe: Year 1

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

Outcome measures

Outcome measures
Measure	Vivo Heart n=28 Participants 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). 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.
Recruitment Rate	2.3 participants per month

SECONDARY outcome

Timeframe: Year 1

Population: The overall number of participants analyzed represents the total number of recruitment letters sent to potentially eligible participants prior to enrollment.

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

Outcome measures

Outcome measures
Measure	Vivo Heart n=685 Participants 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). 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.
Recruitment Yield	4.1 % of eligible participants recruited

SECONDARY outcome

Timeframe: Week 12

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

Outcome measures

Outcome measures
Measure	Vivo Heart n=26 Participants 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). 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.
Compliance Rate Exercise classes attended	75 percentage Standard Deviation 20
Compliance Rate Nutrition classes attended	78 percentage Standard Deviation 26

SECONDARY outcome

Timeframe: Week 12

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

Outcome measures

Outcome measures
Measure	Vivo Heart n=28 Participants 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). 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.
Retention Rate	25 Participants

SECONDARY outcome

Timeframe: Week 12

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

Outcome measures

Outcome measures
Measure	Vivo Heart n=25 Participants 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). 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.
Number of Participants Satisfied With Intervention	25 Participants

SECONDARY outcome

Timeframe: Year 1

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

Outcome measures

Outcome measures
Measure	Vivo Heart n=25 Participants 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). 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.
Continuation Rate	3 Participants

Adverse Events

Vivo Heart

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vivo Heart n=27 participants at risk 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). 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.
Musculoskeletal and connective tissue disorders reinjured low back	3.7% 1/27 • Number of events 1 • baseline through 12 weeks
Skin and subcutaneous tissue disorders toenail fungus	3.7% 1/27 • Number of events 1 • baseline through 12 weeks
Immune system disorders drug reaction	3.7% 1/27 • Number of events 1 • baseline through 12 weeks
Cardiac disorders chest pain during exercise	3.7% 1/27 • Number of events 1 • baseline through 12 weeks
Nervous system disorders carpal tunnel surgery	3.7% 1/27 • Number of events 1 • baseline through 12 weeks
Respiratory, thoracic and mediastinal disorders dyspnea	3.7% 1/27 • Number of events 1 • baseline through 12 weeks
Musculoskeletal and connective tissue disorders sciatica	7.4% 2/27 • Number of events 2 • baseline through 12 weeks
Musculoskeletal and connective tissue disorders back strain from chores	3.7% 1/27 • Number of events 1 • baseline through 12 weeks
Musculoskeletal and connective tissue disorders knee pain from fall	3.7% 1/27 • Number of events 1 • baseline through 12 weeks
Musculoskeletal and connective tissue disorders chronic right shoulder pain	3.7% 1/27 • Number of events 1 • baseline through 12 weeks
Musculoskeletal and connective tissue disorders strained lower back on treadmill	3.7% 1/27 • Number of events 1 • baseline through 12 weeks
Skin and subcutaneous tissue disorders infected sebaceous cyst	3.7% 1/27 • Number of events 1 • baseline through 12 weeks
Nervous system disorders dizziness	3.7% 1/27 • Number of events 1 • baseline through 12 weeks
Immune system disorders influenza B	3.7% 1/27 • Number of events 1 • baseline through 12 weeks

Additional Information

Tina Brinkley, PhD

Wake Forest University School of Medicine

Phone: 336.713.8534

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place