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Wellness & Exercise Program for Single Ventricle Heart Disease
Study Summary
This trial is designed to see if a wellness and exercise program can improve the health of kids with a heart condition called Fontan physiology. The trial will be conducted in two phases and will look at feasibility, safety, and whether the program leads to improvements in areas like quality of life, fitness, and step counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am shorter than 130 centimeters.My heart's pumping ability is severely impaired, confirmed by an echo test within the last 6 months.You have a history of irregular heartbeats during exercise, except for occasional harmless extra heartbeats without any symptoms.I am currently on IV drugs to strengthen my heart muscle.I am between 13 and 18 years old with Fontan physiology.You have had thoughts of hurting yourself or others in the past 6 months.You cannot finish the exercise test during the initial screening.I have severe heart valve issues or blockages diagnosed by an echo in the last 6 months.
- Group 1: Wellness education and Home exercise programs
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Who is eligible to join this medical research initiative?
"This clinical trial is seeking 30 participants between the ages of 13 and 18 who have been diagnosed with frailty."
How many participants are involved in the current investigation?
"Confirmatively, clinicaltrials.gov highlights that this research is presently recruiting participants. According to the initial post on March 30th 2022 and last update on March 31st 2022, this trial requires a total of 30 individuals from one location."
Are recruitment efforts still underway for this clinical trial?
"The research project, which was posted on March 30th 2022 and recently amended the following day, is actively seeking participants. This information can be found via clinicaltrials.gov."
Are individuals over the age of 55 being considered as participants in this research?
"Individuals aged between 13 and 18, inclusively, are qualified to sign up for this clinical trial following the set eligibility criteria."
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