Cardiac Rehabilitation of Children and Adolescent With Long QT Syndrome

NCT05964322 | Completed

• 1 other identifier: RECHMPL23_0225
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 2

Brief 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?

Conditions

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

Keywords

Cardiac Rehabilitation; Long QT syndrome; Pediatric; Exercise training; Educational program

Outcome Measures

Primary Outcomes (4)

• Security

  Count and specify any cardiac events on the ECG scope during each session. Reporting of related and non-related event during the past 7 days through short questionnaire each week.

  At week 12

• Recruitment rates

  Number of participants who completed baseline assessment compared to the number who were eligible (expressed in %).

  At week 12

• Retention rates

  Participants who participated in the 12-week intervention and completed the follow-up assessments at the end of the program (expressed in %).

  At week 12

• Adherence

  Percentage exercise sessions attained by participants compared to number of sessions proposed.

  At week 12

Secondary Outcomes (8)

• Change on cardiorespiratory fitness

  between week 0 and week 12

• Change on muscle architecture

  between week 0 and week 12

• Change on muscle strength

  between week 0 and week 12

• Change on physical activity level

  between week 0 and week 12

• Change on Self reported total score of the Pediatric Quality of Life Inventory (PedsQL) 4.0 questionnaire

  between week 0 and week 12

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 8 to 18 years with an LQTS.

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (2)

University Hospital of Montpellier - Arnaud de Villeneuve Hospita

Montpellier, 34295, France

Location

Saint-Pierre Institute

Palavas-les-Flots, 34250, France

Location

Related Publications (3)

• 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.

  PMID: 36712265 BACKGROUND

• 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.

  PMID: 34321045 BACKGROUND

• 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.

  PMID: 38997778 RESULT

MeSH Terms

Conditions

Long QT Syndrome; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Pascal AMEDRO, Professor

  University Hospital of Bordeaux - Haut-Levêque Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 27, 2023
• Study Start: February 2, 2022
• Primary Completion: March 7, 2023
• Study Completion: December 31, 2024
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

FR (2)