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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05964322

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Enrollment

Locations

22.9

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Long QT Syndrome Congenital Long Qt Syndrome Inherited Cardiac Conduction Disorder Pediatric ALL

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 Design

Study Type:

Observational

Actual Enrollment :

8 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Cardiac Rehabilitation of Children and Adolescent With Long QT Syndrome

Actual Study Start Date :

Feb 2, 2022

Actual Primary Completion Date :

Mar 7, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

Security [At week 12]
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.
Recruitment rates [At week 12]
Number of participants who completed baseline assessment compared to the number who were eligible (expressed in %).
Retention rates [At week 12]
Participants who participated in the 12-week intervention and completed the follow-up assessments at the end of the program (expressed in %).
Adherence [At week 12]
Percentage exercise sessions attained by participants compared to number of sessions proposed.

Secondary Outcome Measures

Change on cardiorespiratory fitness [between week 0 and week 12]
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.
Change on muscle architecture [between week 0 and week 12]
Assessing the following variables by ultrasounding: Anatomical cross sectional area, pennation angle, fascicle length and muscle thickness
Change on muscle strength [between week 0 and week 12]
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.
Change on physical activity level [between week 0 and week 12]
Time spent in vigorous, moderate-to-vigorous, light physical activity assessed by waist-worn tri axial accelerometer during 7 days.
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 [between week 0 and week 12]
Electrocardiographic at rest (QTc, heart rate, PR, QRS interval time) and echocardiography (LVEF, IVSd, IVSs, LVEDV, E/A ratio)

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.