Cardiac Rehabilitation of Children and Adolescent With Long QT Syndrome (RYTHMO'FIT)

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?

Study Overview

• Status: Completed
• Conditions: Pediatric ALL; Long QT Syndrome; Inherited Cardiac Conduction Disorder; Congenital Long Qt Syndrome

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.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital of Montpellier - Arnaud de Villeneuve Hospita
  • Palavas-les-Flots, France, 34250
    • Saint-Pierre Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children aged 8 to 18 years with an LQTS.

Description

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change on cardiorespiratory fitness	Assessing the following variables by cardiopulmonary exercise testing: peak oxygen uptake (VO2peak), ventilatory anaerobic threshold (VAT), ventilatory efficiency (VE/VCO2 slope), maximum heart rate (HR), oxygen pulse (VO2/HR), maximal power, respiratory exchange ratio.	between week 0 and week 12
Change on muscle architecture	Assessing the following variables by ultrasounding: Anatomical cross sectional area, pennation angle, fascicle length and muscle thickness	between week 0 and week 12
Change on muscle strength	Lower and upper limb maximal isometric strength by knee extension and handgrip test, respectively. Lower body explosive muscular strength was assessed by standing long broad jump.	between week 0 and week 12
Change on physical activity level	Time spent in vigorous, moderate-to-vigorous, light physical activity assessed by waist-worn tri axial accelerometer during 7 days.	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
Change on Proxy-reported total score of the Pediatric Quality of Life Inventory (PedsQL)		between week 0 and week 12
Pediatric Quality of Life Inventory (PedsQL) 4.0 Health-related quality (HRQoL ) of life questionnaire score per dimension (self and proxy reports)		between week 0 and week 12
Change on cardiological outcomes	Electrocardiographic at rest (QTc, heart rate, PR, QRS interval time) and echocardiography (LVEF, IVSd, IVSs, LVEDV, E/A ratio)	between week 0 and week 12

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Pascal AMEDRO, Professor, University Hospital of Bordeaux - Haut-Levêque Hospital

Publications and helpful links

General Publications

• 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, 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Actual): March 7, 2023
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Pediatric; Exercise training; Cardiac Rehabilitation; Long QT syndrome; Educational program
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease; Arrhythmias, Cardiac; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Cardiac Conduction System Disease; Syndrome; Long QT Syndrome
• Other Study ID Numbers: RECHMPL23_0225

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No