|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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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.
- 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).
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
|Contact: Seda Tierneyfirstname.lastname@example.org|