Cardiovascular Disease
Conditions
Keywords
home-based cardiac rehabilitation, mobile health technologies, strength and physical function, synchronous virtual exercise program
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).
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.
Sponsors
Wake Forest University Health Sciences
National Institute on Aging (NIA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
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
* \<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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion Rate | Week 12 | Completion rate will be determined by the percentage of enrolled participants who complete the exercise and nutrition classes with ≥80% compliance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | Year 1 | Recruitment rate will be determined by the total number of enrolled participants divided by the number of months recruitment occurred. |
| Recruitment Yield | Year 1 | 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 |
| Compliance Rate | Week 12 | Compliance will be determined based on adherence to the prescribed intervention. Compliance metrics will include attendance at the exercise and nutrition classes. |
| Retention Rate | Week 12 | Retention will be determined by the percentage of enrolled participations who complete follow-up testing. |
| Number of Participants Satisfied With Intervention | Week 12 | Acceptability will be assessed at the end of the study using a program satisfaction survey. |
| Continuation Rate | Year 1 | Continuation rate will be determined by the number of participants who continue in the Vivo program after the study is over. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTina E Brinkley, PhD
Wake Forest University Health Sciences
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66.7 years STANDARD_DEVIATION 4.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 10 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
None listed