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

April 15, 2024 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

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • 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 Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
        • Contact:
        • Principal Investigator:
          • Tina E Brinkley, PhD

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

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
Intervention / Treatment
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

Outcome Measure
Measure Description
Time Frame
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.
Week 12

Secondary Outcome Measures

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
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
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 sessions, health education classes, and dietary counseling sessions.
Week 12
Retention Rate
Time Frame: Week 12
Retention will be determined by the percentage of enrolled participations who complete follow-up testing.
Week 12
Satisfaction Survey Scores
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
Uptake will be determined by the number of participants who continue in the Vivo program after the study is over.
Year 1

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
VO2 peak
Time Frame: Week 12
Change in VO2 peak
Week 12
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
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

Wake Forest University Health Sciences

Collaborators

National Institute on Aging (NIA)

Investigators

  • 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)

March 19, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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