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Wellness & Exercise Program for Single Ventricle Heart Disease
N/A
Recruiting
Led By Jesse Hansen, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and females with Fontan physiology who are 13 to <19 years of age at enrollment
Be younger than 65 years old
Must not have
Height < 130 centimeters
Current intravenous inotropic drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if teaching kids about health in groups and giving them custom exercise plans can help children with a special heart condition become healthier and more active.
Who is the study for?
This trial is for young people aged 13 to <19 with Fontan physiology, a type of heart condition. They must be able to give consent or have it from a guardian, own a mobile device compatible with the study's app, and speak English fluently. Those with severe heart issues, recent suicidality or homicidality, certain height restrictions, IV drug use for heart failure, exercise-induced arrhythmias, inability to complete baseline exercise tests or other conditions that could interfere are excluded.
What is being tested?
The trial evaluates a two-phase program on wellness in pediatric patients with Fontan physiology. Phase one involves group wellness education (WE BEAT), followed by an individualized home exercise regimen (HEART Club). It aims to see if these interventions can safely improve frailty status, oxygen consumption during peak activity levels, daily step counts and overall quality of life without causing serious cardiac events.
What are the potential side effects?
While specific side effects aren't listed due to the non-pharmaceutical nature of this intervention (education and exercise), potential risks may include typical exercise-related issues such as muscle soreness or strain. Serious cardiac events will be monitored as part of the study's safety measures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 13 and 18 years old with Fontan physiology.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am shorter than 130 centimeters.
Select...
I am currently on IV drugs to strengthen my heart muscle.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the Connor-Davidson Resilience Scale 10
Change in the Lurz-Wilde pediatric frailty score
Secondary study objectives
Change in the Patient Reported Outcome Measures Information System (PROMIS) pediatric physical activity -short form 4a
Change in the Patient-Reported Outcomes Measurement Information System Pediatric Profile-25 2.0 (PROMIS-25)
Feasibility of the home exercise intervention program based on the number of adverse events (AEs) Categorized by relatedness to the intervention
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Wellness education and Home exercise programsExperimental Treatment2 Interventions
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for frailty, such as small-group wellness education programs and individualized prescription exercise programs, work by enhancing physical strength, improving cardiovascular health, and boosting mental resilience. These interventions typically include aerobic and resistance training exercises, which help increase muscle mass, improve balance, and enhance overall physical function.
Additionally, wellness education programs provide knowledge and strategies to manage health better, reduce stress, and promote a more active lifestyle. For frailty patients, these treatments are vital as they can significantly improve daily activity levels, reduce the risk of falls, and enhance the quality of life by fostering greater independence and resilience.
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Who is running the clinical trial?
University of MichiganLead Sponsor
1,843 Previous Clinical Trials
6,429,747 Total Patients Enrolled
3 Trials studying Frailty
103 Patients Enrolled for Frailty
Reuben Phoenix Schostak Fontan Wellness Project FundUNKNOWN
Jesse Hansen, MDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
53 Total Patients Enrolled
1 Trials studying Frailty
53 Patients Enrolled for Frailty
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Wellness education and Home exercise programs
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.
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