Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-24 @ 6:49 PM
NCT ID:
NCT05199857
Brief Summary:
This trial is being conducted to evaluate the effect of a small-group wellness education program combined with a longitudinal, individualized prescription exercise program on the wellness, resiliency, and daily activity levels of pediatric patients with Fontan physiology.
There will be two phases for this project. The first phase is the "WE BEAT Group Wellness Education Program" and participants will be transitioned into the phase two HEART Club following phase one.
The trial will look at feasibility and acceptability of the program. Additional hypothesis include home whether exercise interventions can:
* be delivered without any associated serious cardiac events;
* will result in a decreased proportion of patients who are categorized as frail when compared to the cohort's pre-test baseline.
* will result in increased measured peak oxygen consumption when compared with their pre-intervention baseline.
* will result in increased step counts measured monthly from baseline to end of intervention
* will improve self-reported quality of life from baseline to post-intervention.
* will result in increased patient reported activity level from baseline to post-intervention
Study:
NCT05199857
Study Brief:
Protocol Section:
NCT05199857