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App-Enabled Exercise Program for Congenital Heart Disease
N/A
Recruiting
Led By Reid C Chamberlain, MD, MSCI
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Repaired or unrepaired Congenital Heart Disease (CHD) between ages 10 and 50, inclusive, at time of consent
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will create an app-enabled exercise program for CHD patients with real-time data collection & safety monitoring, to be applied to other conditions in the future. #healthcare #telemedicine
Who is the study for?
This trial is for people aged 10-50 with Congenital Heart Disease (CHD), who have an Android (6.0+) or Apple smartphone (iOS 13+). It's not for pregnant individuals, those with disabilities that prevent exercise, uncontrolled high blood pressure, poorly managed arrhythmia, or unstable heart failure.Check my eligibility
What is being tested?
The Strong Hearts Exercise Program is being tested to see if a mobile app can help patients with CHD exercise safely. The app includes exercise modules and uses wearable devices to track real-time data on compliance and safety.See study design
What are the potential side effects?
Since this program involves physical activity tailored for CHD patients, potential side effects may include typical exercise-related issues such as muscle soreness or fatigue. However, the program aims to minimize risks by monitoring participants' health.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have congenital heart disease and am between 10 and 50 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in peak rate of oxygen volume consumption (VO2) on Cardiopulmonary Exercise Testing
Secondary outcome measures
Change in Pediatric Cardiac Quality of Life Inventory
Change in Short Form 36 (SF-36) Health Survey
Change in secondary Cardiopulmonary Exercise Testing outcome measures
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Exercise GroupExperimental Treatment1 Intervention
Participants will participate in a remote, app-enabled exercise program consisting of strength and aerobic exercises for four to twelve weeks. They will perform the exercises 3-5 times a week at home guided by exercise videos in the app. The exercise sessions will increase in frequency throughout the training regimen. The videos will include athletes demonstrating how to perform each exercise safely, and provide tips for optimal form and breathing. Participants will wear wearable fitness trackers and monitor their heart rates during exercise sessions.
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,364 Previous Clinical Trials
3,420,442 Total Patients Enrolled
Food and Drug Administration (FDA)FED
171 Previous Clinical Trials
1,331,406 Total Patients Enrolled
Reid C Chamberlain, MD, MSCIPrincipal InvestigatorDuke UMC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have congenital heart disease and am between 10 and 50 years old.I have a disability that stops me from exercising.My high blood pressure is not controlled even with medication.I have a heart rhythm problem that is not well-controlled.My heart failure is not stable.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise Group
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.
Does the criterion for this trial permit those over 75 years of age to participate?
"To qualify for this medical experiment, individuals must be between 10 and 50 years old. Separately, there are 102 clinical trials targeted at those under 18 and 274 designed for the elderly population."
Answered by AI
What demographics are most suitable for this experiment?
"This medical trial is recruiting approximately 200 individuals with congenital heart disease and ages ranging from 10 to 50."
Answered by AI
Are recruitment efforts underway for this clinical trial?
"Clinicaltrials.gov divulges that this trial, posted on June 1st 2023 and last updated May 8th of the same year, is not currently recruiting patients; however, there are 355 other studies actively seeking participants."
Answered by AI
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