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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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:
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.
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| 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 |
| 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 |
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Children aged 8 to 18 years with an LQTS.
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| Name | Affiliation | Role |
|---|---|---|
| Pascal AMEDRO, Professor | University Hospital of Bordeaux - Haut-Levêque Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Montpellier - Arnaud de Villeneuve Hospita | Montpellier | 34295 | France | |||
| Saint-Pierre Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36712265 | Background | 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. | |
| 34321045 |
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| ID | Term |
|---|---|
| D008133 | Long QT Syndrome |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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| 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 |
| Palavas-les-Flots |
| 34250 |
| France |
| Background |
| 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. |
| 38997778 | Result | 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. |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |