Cardiac Rehabilitation of Children and Adolescent With Long QT Syndrome

Pediatric ALL Clinical Trial

— RYTHMO'FIT  

Official title:

Cardiac Rehabilitation of Children and Adolescent With Long QT Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05964322
• Other study ID #: RECHMPL23_0225
• Status: Active, not recruiting
• Start date: February 2, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: December 31, 2023
• Est. primary completion date: March 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Inherited Cardiac Conduction Disorder
• Long QT Syndrome
• Pediatric ALL
• Syndrome

Locations

Country	Name	City	State
France	University Hospital of Montpellier - Arnaud de Villeneuve Hospita	Montpellier
France	Saint-Pierre Institute	Palavas-les-Flots

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Recruitment rates	Number of participants who completed baseline assessment compared to the number who were eligible (expressed in %).	At week 12
Primary	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
Primary	Adherence	Percentage exercise sessions attained by participants compared to number of sessions proposed.	At week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change on Self reported total score of the Pediatric Quality of Life Inventory (PedsQL) 4.0 questionnaire		between week 0 and week 12
Secondary	Change on Proxy-reported total score of the Pediatric Quality of Life Inventory (PedsQL)		between week 0 and week 12
Secondary	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
Secondary	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