Cardiac Rehabilitation of Children and Adolescent With Long QT Syndrome
NCT ID: NCT05964322
Last Updated: 2025-07-31
Study Results
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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COMPLETED
8 participants
OBSERVATIONAL
2022-02-02
2024-12-31
Brief Summary
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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?
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Detailed Description
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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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Study Design
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CASE_ONLY
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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.
6 Years
18 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University Hospital, Montpellier
OTHER
Responsible Party
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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
Saint-Pierre Institute
Palavas-les-Flots, , France
Countries
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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.
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.
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.
Other Identifiers
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RECHMPL23_0225
Identifier Type: -
Identifier Source: org_study_id
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