Clinical trial NCT05964322: Cardiac Rehabilitation of Children and Adolescent With Long QT Syndrome
Official title: Cardiac Rehabilitation of Children and Adolescent With Long QT Syndrome
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2023-07-27
Enrollment: 8
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 8 to 18 years with an LQTS.

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?

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.

Eligibility 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.

Primary outcomes:
measure: Security
timeFrame: At week 12
measure: Recruitment rates
timeFrame: At week 12
measure: Retention rates
timeFrame: At week 12
measure: Adherence
timeFrame: At week 12
Secondary outcomes:
measure: Change on cardiorespiratory fitness
timeFrame: between week 0 and week 12
measure: Change on muscle architecture
timeFrame: between week 0 and week 12
measure: Change on muscle strength
timeFrame: between week 0 and week 12
measure: Change on physical activity level
timeFrame: between week 0 and week 12
measure: Change on Self reported total score of the Pediatric Quality of Life Inventory (PedsQL) 4.0 questionnaire
timeFrame: between week 0 and week 12
measure: Change on Proxy-reported total score of the Pediatric Quality of Life Inventory (PedsQL)
timeFrame: between week 0 and week 12
measure: Pediatric Quality of Life Inventory (PedsQL) 4.0 Health-related quality (HRQoL ) of life questionnaire score per dimension (self and proxy reports)
timeFrame: between week 0 and week 12
measure: Change on cardiological outcomes
timeFrame: between week 0 and week 12
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier - Arnaud de Villeneuve Hospita
city: Palavas-les-Flots
country: France
facility: Saint-Pierre Institute
Study officials:
affiliation: University Hospital of Bordeaux - Haut-Levêque Hospital
name: Pascal AMEDRO, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.