Clinical Trials Directory

Trials / Completed

CompletedNCT05964322

Cardiac Rehabilitation of Children and Adolescent With Long QT Syndrome

Status
Completed
Phase
Study type
Observational
Enrollment
8 (actual)
Sponsor
University Hospital, Montpellier · Academic / Other
Sex
All
Age
6 Years – 18 Years
Healthy volunteers
Not accepted

Summary

Children and adolescents with inherited cardiac arrhythmia su ch Long QT Syndrome (LQTS) have lower physical and quality of life than their healthy peers. A multi-component cardiac rehabilitation, including an exercise training program and education program, might counteract those effects. The goal of this pilot study is to evaluate the security, feasibility, and benefits of a cardiac rehabilitation program in children with LQTS aged between 6 to 18 years old. The main question\[s\] it aims to answer are: * Is center-based cardiac rehabilitation safe and feasible for children with LQTS? * Does a 12-week cardiac rehabilitation program improve physical fitness and quality of life?

Detailed description

Physical fitness is an independent predictor of all-cause mortality and global health in the general population. Assessments of cardiorespiratory and muscle fitness in children with chronic illness are growing in interest, even in less prevalent chronic diseases. For instance, children and adolescents with Long QT Syndrome (LQTS) have lower cardiorespiratory fitness, muscle strength, and quality of life than their healthy peers. A multi-component cardiac rehabilitation including an exercise training program and education program might counteract this lowered physical fitness. The RYTHMO'FIT pilot study seeks to test the security, and feasibility, and to evaluate the benefits of an innovative center-based program to improve physical and mental health in children and adolescents with LQTS. In this retrospective study, eight children had undergone a 12-week program, within each session composed by: * A 1-hour exercise training session with a trained exercise physiologist: resistance training, aerobic training, stretching, and different activity (e.g., basketball, handball, football, hockey) * A 30-min educational workshop with a specialist nurse (e.g., beta-blockade, sports participation, healthy behaviors). * A 10-min medical interview with a cardiologist to have feedback from parents and patients on each session and the past 7 seven days. We hypothesized the RYTHMO'FIT study is safe, feasible, and provides benefits for mental and physical health in children and adolescents with LQTS. If the results of this pilot study are positive, they will lead to a larger randomized multicentric controlled trial to evaluate the effectiveness of a hybrid cardiac rehabilitation program in children, adolescents, and young adults with LQTS.

Conditions

Timeline

Start date
2022-02-02
Primary completion
2023-03-07
Completion
2024-12-31
First posted
2023-07-27
Last updated
2025-07-31

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT05964322. Inclusion in this directory is not an endorsement.