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NCT06015191 · ClinicalTrials.gov registry record · NA
Remote Cardiac Rehab for Adolescents With Congenital Heart Disease
A NA study of Congenital Heart Disease in Children, sponsored by Children's Mercy Hospital Kansas City.
- Recruiting
- Registry status
- NA
- Development phase
- 74
- Enrollment target
- 1
- Study location
NCT06015191 is a NA study of Congenital Heart Disease in Children that is actively recruiting participants, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 74 participants, below the 2,006-participant average among 6 other Congenital Heart Disease in Children trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06015191, a NA study of Congenital Heart Disease in Children, is actively recruiting participants, sponsored by Children's Mercy Hospital Kansas City.
- RECRUITING
- Registry status
- NA
- Development phase
- 74 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this randomized controlled trial is to evaluate the effectiveness of video conferencing for the delivery of live-supervised, real-time cardiac rehabilitation (CR) exercise training to groups of adolescents with congenital heart disease (CHD) in their homes. Participants will be randomized to either the remote cardiac rehab (RCR) group or active control group. The RCR group will participate in live, group-based exercise training (3-5 participants per exercise session), in their homes 3 days per week for 45 minutes over 12-weeks. Exercise sessions will be led and supervised by a live health coach via telehealth video technology. The active control group will be provided informational handouts on health exercise for their cardiac diagnosis. The primary aim is to compare between group changes (0-12-weeks) in cardiorespiratory fitness (VO2peak). Secondary aims are to compare between group changes (0-12-weeks) in cardiac function (echocardiography), lean body mass, and physical frailty. Exploratory aims will compare between group changes (0-12-weeks) in physical function, quality of life, skeletal muscle function, and physical activity self-efficacy. Additionally, exploratory aims will explore the impact of demographic characteristics, program participation, program satisfaction, and daily physical activity on changes in cardiorespiratory fitness.
Conditions Studied
Interventions
- BEHAVIORAL Active Control
- BEHAVIORAL Remote Cardiac Rehabilitation
Study Locations (1)
Missouri
- Children's Mercy Kansas City - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2023-08-31 |
| Est. Completion | 2027-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06015191
The ClinicalTrials.gov registry entry for NCT06015191 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,006-participant average among 6 other Congenital Heart Disease in Children trials with a reported enrollment target (96% lower). The listed sponsor is Children's Mercy Hospital Kansas City, which has 184 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Congenital Heart Disease in Children appearing as the primary indexed condition, and to 2 interventions - of which Active Control is the first listed.
NCT06015191 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT06015191 about?
NCT06015191 is a clinical study titled "Remote Cardiac Rehab for Adolescents With Congenital Heart Disease". The goal of this randomized controlled trial is to evaluate the effectiveness of video conferencing for the delivery of live-supervised, real-time cardiac rehabilitation (CR) exercise training to groups of adolescents with congenital heart disease (CHD) in their homes. Participants will be randomize...
What is the current status of trial NCT06015191?
This trial is currently recruiting. It is a NA study. The enrollment target is 74 participants. The study started on 2023-08-31. Estimated completion is 2027-12.
What conditions does trial NCT06015191 study?
This clinical trial studies the following conditions: Congenital Heart Disease in Children.
What interventions are being tested in trial NCT06015191?
The interventions under investigation include: Active Control (BEHAVIORAL), Remote Cardiac Rehabilitation (BEHAVIORAL).
Who is sponsoring clinical trial NCT06015191?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06015191 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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