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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG021332 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivo Heart | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivo Heart | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Completion Rate | Completion rate which will be determined by the percentage of enrolled participants who complete the study with ≥80% compliance. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Recruitment rate will be determined by the total number of enrolled participants divided by the number of months recruitment occurred. | Year 1 |
| Recruitment Yield | Recruitment yield will be determined based on the number of participants randomized relative to the total number of volunteers screened |
| Measure | Description | Time Frame |
|---|---|---|
| VO2 peak | Change in VO2 peak | Week 12 |
| Montreal Cognitive Assessment (MoCA) | Change in overall cognition (0-30) | Week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tina E Brinkley, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 6, 2026 | |
| Reset | Jun 2, 2026 | |
| Release | Jun 12, 2026 | |
| Reset | Jul 9, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 23, 2024 | May 28, 2025 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 6, 2026 | Jun 2, 2026 | |||
| Jun 12, 2026 |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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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.
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| Year 1 |
| 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 |
| Retention Rate | Retention will be determined by the percentage of enrolled participations who complete follow-up testing. | Week 12 |
| Satisfaction Survey Scores | Acceptability will be assessed at the end of the study using a program satisfaction survey. | Week 12 |
| Continuation Rate | Uptake will be determined by the number of participants who continue in the Vivo program after the study is over. | Year 1 |
| Digit Symbol Coding (DSC) | Change in processing speed, working memory, visuospatial processing, and attention (secs) | Week 12 |
| Timed Up and Go (TUG) | Change in time to complete (secs) | Week 12 |
| Expanded Short Physical Performance Battery (eSPPB) | Change in score (0-4) | Week 12 |
| The Four Square Step Test (FSST) | Change in time to complete (secs) | Week 12 |
| 4-step Stair Climb Test (4SCT) | Change in time to complete (secs) | Week 12 |
| Grip Strength | Change in grip strength (kg) | Week 12 |
| Perceived Stress Scale (PSS) | Change in score | Week 12 |
| Short Form-36 Health Survey (SF-36) | Change in score | Week 12 |
| UCLA Loneliness Scale | Change in score | Week 12 |
| Life Space | Change in score | Week 12 |
| Pittsburgh Fatigability Scale (PFS) | Change in score | Week 12 |
| Blood pressure | Change in systolic and diastolic blood pressure (mmHg) | Week 12 |
| Heart rate | Change in resting heart rate (bpm) | Week 12 |
| Jul 9, 2026 |