What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for frailty, such as small-group wellness education programs and individualized prescription exercise programs, generally have minimal side effects. However, some individuals may experience muscle soreness, fatigue, or minor injuries related to physical activity. Additionally, there may be psychological effects such as frustration or decreased motivation if progress is slower than expected. It is important for these programs to be tailored to individual capabilities to minimize risks and enhance benefits.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of frailty. However, behavioral interventions such as small-group wellness education programs and individualized prescription exercise programs have been studied for their potential benefits in improving wellness, resiliency, and daily activity levels in frail individuals. These interventions focus on increasing physical activity, enhancing social support, and promoting overall health, which are critical components in managing frailty.

What other types of research exist?

Promising alternatives for frailty patients include: 1) Digital Cognitive Behavioral Therapy for Insomnia (CBT-I), which has shown improvements in sleep-related quality of life and insomnia symptoms, potentially enhancing overall wellness and resiliency. 2) Mindfulness-based stress reduction and yoga, which have been effective in reducing anxiety and improving mental health. 3) Community-integrated home-based depression treatment, which has demonstrated benefits in managing depression and enhancing daily functioning in older adults. 4) Progressive muscle relaxation and guided imagery, which have been effective in managing pain and improving quality of life in patients with chronic conditions.

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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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

0 / 3Eligibility criteria met

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.