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NCT05199857 · ClinicalTrials.gov registry record · NA
WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program
A NA study of Frailty and Single Ventricle Heart Disease, sponsored by University of Michigan.
- Active
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05199857 is a NA study of Frailty and Single Ventricle Heart Disease that is active but no longer recruiting, run by University of Michigan. The registered enrollment target is 30 participants, below the 1,506-participant average among 48 other Frailty trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05199857, a NA study of Frailty and Single Ventricle Heart Disease, is active but no longer recruiting, sponsored by University of Michigan.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- BEHAVIORAL WE BEAT Group Wellness Education program - phase 1
- BEHAVIORAL HEART Club Home Exercise program - phase 2
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-03-30 |
| Est. Completion | 2026-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05199857
The ClinicalTrials.gov registry entry for NCT05199857 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,506-participant average among 48 other Frailty trials with a reported enrollment target (98% lower). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Frailty appearing as the primary indexed condition, and to 2 interventions - of which WE BEAT Group Wellness Education program - phase 1 is the first listed.
NCT05199857 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT05199857 about?
NCT05199857 is a clinical study titled "WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program". 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 f...
What is the current status of trial NCT05199857?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2022-03-30. Estimated completion is 2026-07.
What conditions does trial NCT05199857 study?
This clinical trial studies the following conditions: Frailty, Single Ventricle Heart Disease, Fontan Physiology.
What interventions are being tested in trial NCT05199857?
The interventions under investigation include: WE BEAT Group Wellness Education program - phase 1 (BEHAVIORAL), HEART Club Home Exercise program - phase 2 (BEHAVIORAL).
Who is sponsoring clinical trial NCT05199857?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05199857 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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