Cardiac Rehabilitation of Children and Adolescent With Long QT Syndrome

NCT ID: NCT05964322

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-02

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Long QT Syndrome Congenital Long Qt Syndrome Inherited Cardiac Conduction Disorder Pediatric ALL

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Children and adolescents, aged 6 to 18 years old, diagnosed with congenital LQTS and had been recently under medical check-up in our last study QUALIMYORYTHM
* With impaired cardiorespiratory fitness (VO2 peak \<80% of predicted values or VAT \<55% of predicted values) or with normal cardiorespiratory fitness but requiring patient education and information on limits/security in taking part in sports participation.
* Willingness and ability for parents and children to take part in a 12-week center-based program (e.g., availability during the school period, transportation options)
* Informed consent of parents or legal guardians, and oral assent of children.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal AMEDRO, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Bordeaux - Haut-Levêque Hospital

Locations

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University Hospital of Montpellier - Arnaud de Villeneuve Hospita

Montpellier, , France

Site Status

Saint-Pierre Institute

Palavas-les-Flots, , France

Site Status

Countries

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France

References

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Souilla L, Avesani M, Boisson A, Requirand A, Matecki S, Vincenti M, Werner O, De La Villeon G, Pommier V, Pasquie JL, Guillaumont S, Amedro P. Cardiorespiratory fitness, muscle fitness, and physical activity in children with long QT syndrome: A prospective controlled study. Front Cardiovasc Med. 2023 Jan 11;9:1081106. doi: 10.3389/fcvm.2022.1081106. eCollection 2022.

Reference Type BACKGROUND
PMID: 36712265 (View on PubMed)

Amedro P, Werner O, Abassi H, Boisson A, Souilla L, Guillaumont S, Calderon J, Requirand A, Vincenti M, Pommier V, Matecki S, De La Villeon G, Lavastre K, Lacampagne A, Picot MC, Beyler C, Delclaux C, Dulac Y, Guitarte A, Charron P, Denjoy-Urbain I, Probst V, Baruteau AE, Chevalier P, Di Filippo S, Thambo JB, Bonnet D, Pasquie JL. Health-related quality of life and physical activity in children with inherited cardiac arrhythmia or inherited cardiomyopathy: the prospective multicentre controlled QUALIMYORYTHM study rationale, design and methods. Health Qual Life Outcomes. 2021 Jul 28;19(1):187. doi: 10.1186/s12955-021-01825-6.

Reference Type BACKGROUND
PMID: 34321045 (View on PubMed)

Souilla L, Guillaumont S, Auer A, Metzler G, Requirand A, Vincenti M, De La Villeon G, Pasquie JL, Mottet D, Amedro P. Cardiac rehabilitation in children and adolescents with long QT syndrome: the RYTHMO'FIT pilot study. BMC Sports Sci Med Rehabil. 2024 Jul 12;16(1):152. doi: 10.1186/s13102-024-00941-2.

Reference Type RESULT
PMID: 38997778 (View on PubMed)

Other Identifiers

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RECHMPL23_0225

Identifier Type: -

Identifier Source: org_study_id

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