Clinical trial NCT05972850: Vivo Heart: Home-Based Virtual Exercise Program for Older Adults With Cardiovascular Disease
Official title: Vivo Heart: Home-Based Virtual Exercise Program for Older Adults With Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: home-based cardiac rehabilitation
mobile health technologies
strength and physical function
synchronous virtual exercise program
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-08-02
Enrollment: 27
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Completion Rate
timeFrame: Week 12
Secondary outcomes:
measure: Recruitment Rate
timeFrame: Year 1
measure: Recruitment Yield
timeFrame: Year 1
measure: Compliance Rate
timeFrame: Week 12
measure: Retention Rate
timeFrame: Week 12
measure: Satisfaction Survey Scores
timeFrame: Week 12
measure: Continuation Rate
timeFrame: Year 1
Other outcomes:
measure: VO2 peak
timeFrame: Week 12
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Week 12
measure: Digit Symbol Coding (DSC)
timeFrame: Week 12
measure: Timed Up and Go (TUG)
timeFrame: Week 12
measure: Expanded Short Physical Performance Battery (eSPPB)
timeFrame: Week 12
measure: The Four Square Step Test (FSST)
timeFrame: Week 12
measure: 4-step Stair Climb Test (4SCT)
timeFrame: Week 12
measure: Grip Strength
timeFrame: Week 12
measure: Perceived Stress Scale (PSS)
timeFrame: Week 12
measure: Short Form-36 Health Survey (SF-36)
timeFrame: Week 12
measure: UCLA Loneliness Scale
timeFrame: Week 12
measure: Life Space
timeFrame: Week 12
measure: Pittsburgh Fatigability Scale (PFS)
timeFrame: Week 12
measure: Blood pressure
timeFrame: Week 12
measure: Heart rate
timeFrame: Week 12
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Tina E Brinkley, PhD
role: PRINCIPAL_INVESTIGATOR
References: