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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05972850
• Other study ID #: IRB00094007
• Secondary ID: P30AG021332
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 19, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	VO2 peak	Change in VO2 peak	Week 12
Other	Montreal Cognitive Assessment (MoCA)	Change in overall cognition (0-30)	Week 12
Other	Digit Symbol Coding (DSC)	Change in processing speed, working memory, visuospatial processing, and attention (secs)	Week 12
Other	Timed Up and Go (TUG)	Change in time to complete (secs)	Week 12
Other	Expanded Short Physical Performance Battery (eSPPB)	Change in score (0-4)	Week 12
Other	The Four Square Step Test (FSST)	Change in time to complete (secs)	Week 12
Other	4-step Stair Climb Test (4SCT)	Change in time to complete (secs)	Week 12
Other	Grip Strength	Change in grip strength (kg)	Week 12
Other	Perceived Stress Scale (PSS)	Change in score	Week 12
Other	Short Form-36 Health Survey (SF-36)	Change in score	Week 12
Other	UCLA Loneliness Scale	Change in score	Week 12
Other	Life Space	Change in score	Week 12
Other	Pittsburgh Fatigability Scale (PFS)	Change in score	Week 12
Other	Blood pressure	Change in systolic and diastolic blood pressure (mmHg)	Week 12
Other	Heart rate	Change in resting heart rate (bpm)	Week 12
Primary	Completion Rate	Completion rate which will be determined by the percentage of enrolled participants who complete the study with =80% compliance.	Week 12
Secondary	Recruitment Rate	Recruitment rate will be determined by the total number of enrolled participants divided by the number of months recruitment occurred.	Year 1
Secondary	Recruitment Yield	Recruitment yield will be determined based on the number of participants randomized relative to the total number of volunteers screened	Year 1
Secondary	Compliance Rate	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
Secondary	Retention Rate	Retention will be determined by the percentage of enrolled participations who complete follow-up testing.	Week 12
Secondary	Satisfaction Survey Scores	Acceptability will be assessed at the end of the study using a program satisfaction survey.	Week 12
Secondary	Continuation Rate	Uptake will be determined by the number of participants who continue in the Vivo program after the study is over.	Year 1