Healthy-related Quality of Life and Physical Activity of Children With Cardiac Malformations
NCT04712136
Aortic Stenosis, Subvalvular, Aortic Valve Disease
Montpellier, Occitanie, France
View Trial DetailsNCT Number: NCT05964322
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?
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Notify Me6 year–18 year
All sexes
Observational
University Hospital of Montpellier - Arnaud de Villeneuve Hospita, Montpellier, France
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Time frame: 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.
Time frame: At week 12
Number of participants who completed baseline assessment compared to the number who were eligible (expressed in %).
Time frame: 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 %).
Time frame: At week 12
Percentage exercise sessions attained by participants compared to number of sessions proposed.
Time frame: 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.
Time frame: between week 0 and week 12
Assessing the following variables by ultrasounding: Anatomical cross sectional area, pennation angle, fascicle length and muscle thickness
Time frame: 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.
Time frame: 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.
Time frame: between week 0 and week 12
Time frame: between week 0 and week 12
Time frame: between week 0 and week 12
Time frame: 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)
University Hospital, Montpellier
Other
Acronym: RYTHMO'FIT
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