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Trial record 2 of 3 for:    re-energize

Re-Energize Fontan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04195451
Recruitment Status : Not yet recruiting
First Posted : December 11, 2019
Last Update Posted : April 2, 2020
Sponsor:
Collaborator:
The Methodist Hospital System
Information provided by (Responsible Party):
Seda Tierney, Stanford University

Brief Summary:
Survival of children with single ventricles ("half a heart") beyond the neonatal period has increased dramatically with the staged Fontan palliation. Yet, long-term morbidity remains high. By the age of 40, 50% of Fontan patients will have died or undergone heart transplantation. With >1,000 Fontan palliations performed in the US annually, there is a burgeoning population of Fontan patients at risk for progressive heart failure and death. Factors that contribute to onset and progression of heart failure in Fontan patients remain incompletely understood. However, it is established that Fontan patients have poor exercise capacity, associated with a greater risk of morbidity and mortality, in addition to decreased muscle mass, abnormal muscle function, and endothelial dysfunction contributing to disease progression. In adult patients with two ventricles and heart failure, reduced exercise capacity, muscle mass, and muscle strength are powerful predictors of poor outcomes, and exercise interventions can not only improve exercise capacity and muscle mass, but also reverse endothelial dysfunction. Limited exercise interventions in children with congenital heart disease have demonstrated that exercise is safe and effective; however, these studies have been conducted in small, heterogeneous groups, and most had few Fontan patients. Furthermore, none of these interventions have studied the impact of exercise on muscle mass or mitochondrial function, or endothelial function. The investigators propose a milestone-driven, randomized controlled trial in pediatric Fontan patients to test the hypothesis that a live-video-supervised exercise (aerobic + resistance) intervention will improve cardiac and physical capacity; muscle mass, strength and function; and endothelial function. The investigators' ultimate goal is the translation of this model to clinical application as an "exercise prescription" to intervene early in pediatric Fontan patients and decrease long-term morbidity and mortality.

Condition or disease Intervention/treatment Phase
Single-ventricle Other: Live-Video-Supervised Exercise Intervention Other: Usual Care then Live-Video Supervised Exercise Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: RE-ENERGIZE FONTAN: A RandomizEd Exercise INtERvention DesiGned to MaximIZE Fitness in Pediatric FONTAN Patients
Estimated Study Start Date : May 6, 2020
Estimated Primary Completion Date : October 6, 2024
Estimated Study Completion Date : January 6, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Live Video-Supervised Exercise Intervention Arm
Patients randomized to exercise intervention at baseline will participate in live-video-supervised exercise sessions x3/week for 3 months, and then will follow a maintenance regimen for 6 months. During maintenance, patients will continue live-video-supervised exercise sessions, only x1/week, and will be instructed to exercise on their own x2/week following an individualized prescribed exercise program and use their heart rate monitor as an activity tracker.
Other: Live-Video-Supervised Exercise Intervention
The live-video-supervised exercise intervention includes exercise sessions x3/week for 3 months, and then maintenance regimen for 6 months. Maintenance includes live-video-supervised exercise sessions, only x1/week, and self-exercise x2/week following an individualized prescribed exercise program and use their heart rate monitor as an activity tracker.

Experimental: Live-Video-Supervised Exercise Control Arm
Patients randomized to usual care at baseline will receive usual care for 9 months and will then start the 3-month exercise intervention of live-video-supervised exercise sessions x3/week for 3 months.
Other: Usual Care then Live-Video Supervised Exercise Intervention
Patients randomized to usual care at baseline will receive usual care for 9 months and will then start the live-video-supervised exercise intervention that includes exercise sessions x3/week for 3 months.




Primary Outcome Measures :
  1. Change in volume of Oxygen Consumed at Maximal Exertion [ Time Frame: Baseline, 3 months, 9 months, 12 months ]
    In Fontan patients, VO2 max is a powerful predictor of poor outcomes. The subjects will undergo progressive cardiopulmonary exercise testing with continuous monitoring by 12-lead EKG and gas exchange by measuring breath-to-breath ventilation. Exercise capacity will be measured by a cardiopulmonary exercise test to obtain the maximal oxygen uptake (VO2 max).



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 9-19 years of age
  • Fontan palliation
  • Ability to fast overnight
  • Cardiac clearance to exercise by primary cardiologist
  • Presence of an adult at home during exercise sessions for patients <14 years old
  • English-speaking patient.

Exclusion Criteria:

  • NYHA Class IV (severe heart failure)
  • Acute illness within the past three months
  • Active protein losing enteropathy (albumin <2.5 mg/dL)
  • Implanted pacemaker
  • Cognitive delay deemed severe enough to inhibit the ability to follow the exercise

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04195451


Contacts
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Contact: Seda Tierney 650-724-9408 tierneys@stanford.edu

Sponsors and Collaborators
Stanford University
The Methodist Hospital System
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Responsible Party: Seda Tierney, Associate Professor, Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT04195451    
Other Study ID Numbers: 46606
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seda Tierney, Stanford University:
Fontan palliation