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Behavioural Intervention
Virtual Exercise Program for Cardiovascular Disease
N/A
Waitlist Available
Led By Tina E Brinkley, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 1
Awards & highlights
Study Summary
This trial will assess a novel home-based exercise program to improve strength, endurance, balance, and cognition for rural adults with CVD. Certified trainers will lead interactive 45-min sessions 2-3 times/week for 12 weeks. Results will measure feasibility, acceptability, and impact on exercise capacity, strength, and more.
Who is the study for?
The Vivo Heart trial is for rural adults aged 60-80 with recent cardiovascular events, who are medically cleared for exercise and not doing much physical activity currently. They need internet access and a device to participate in virtual sessions but can't join if they use oxygen for COPD, have clinical depression, or other major health issues.Check my eligibility
What is being tested?
Vivo Heart tests a home-based exercise program tailored for older adults with heart disease. It involves live online group fitness that focuses on strength, endurance, balance, cognition and social interaction through certified trainers over a 12-week period.See study design
What are the potential side effects?
Since this is an exercise program rather than medication, side effects may include typical post-exercise symptoms like muscle soreness or fatigue. However, the risk of injury will be minimized by professional guidance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Completion Rate
Secondary outcome measures
Compliance Rate
Continuation Rate
Recruitment Rate
+3 moreOther outcome measures
4-step Stair Climb Test (4SCT)
Blood pressure
Digit Symbol Coding (DSC)
+12 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Vivo HeartExperimental Treatment1 Intervention
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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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,143 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,668 Previous Clinical Trials
28,005,024 Total Patients Enrolled
Tina E Brinkley, PhDPrincipal InvestigatorWake Forest University Health Sciences
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot walk on my own and may need help or a device to move around.I need dialysis now or will need it in the next 6 months due to advanced kidney disease.I have lasting effects from a previous stroke.I haven't had heart disease or any related procedures in the last year.I cannot walk on my own due to severe arthritis or a similar condition.I use insulin to manage my diabetes.I have been diagnosed with clinical depression.I have not had joint surgery in the last year and don't plan to in the next 6 months.I use extra oxygen for my COPD.I am between 60 and 80 years old.I can arrange my own travel to study visits.My neurological condition is getting worse.I had a heart-related event or procedure in the last year.I have had cancer treatment, excluding non-melanoma skin cancers, in the last year.I don't have a way to get to study visits.I can walk and live at home.I am either younger than 60 or older than 80.
Research Study Groups:
This trial has the following groups:- Group 1: Vivo Heart
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment limited to participants over 35 years of age or are younger individuals qualified for this trial?
"To be eligible for this trial, applicants must fall in the age range of 60 to 80 years old. There are 32 trials available for participants younger than 18 whereas 404 studies can accommodate patients above 65 years old."
Answered by AI
To what population is this clinical trial open for enrollment?
"Candidates for this trial must have cardiovascular disease and be aged between 60 to 80 years old. A total of forty participants are able to join in the study."
Answered by AI
Are there any available vacancies for participants in this experiment?
"As per the information posted on clinicaltrials.gov, enrolling is not presently being sought for this clinical trial (initially published on September 1st 2023 and last updated July 25th 2023). Although no recruitment efforts are underway now, there are 450 other trials actively looking for participants at this moment."
Answered by AI
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