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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01806-41 | Other Identifier | ID-RCB number |
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Standard cardiovascular rehabilitation is performed in a medical care and rehabilitation centre. However, it may not be adapted to the patient's profile and there are few medical care and rehabilitation centres specialized in pediatric cardiology. The objective of this study is to evaluate the impact of cardiovascular rehabilitation entirely at home on the physical fitness of young patients with congenital heart disease.
Young patients with congenital heart disease suffer from physical deconditioning [1], negatively impacting the quality of life [2, 3], due in particular to obstacles stated by the patient's social environment [4, 5]. For this, there is cardiovascular rehabilitation, however, it may not be adapted to the patient's profile and there are few specialized centres in France. In the sense, the QUALIREHAB program, tested in a randomized controlled trial, was created. This 3-month hybrid program (at the patient's home and in a medical care and rehabilitation centre), combining adapted physical activity, patient therapeutic education and psychosocial support, has demonstrated positive effects on quality of life, level of physical activity, knowledge of the disease, body mass index and mental health [6].
However, this program has limitations, including the need for a medical care and rehabilitation centre near the patient's home.
This study, evaluating the impact of a 3-month cardiovascular rehabilitation program entirely at home, will improve this program by taking into account its limitations and will apply it to real life, without all the human, financial and material resources of a randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fully home-based cardiovascular rehabilitation program | Experimental | 3-month cardiovascular rehabilitation program entirely at home, combining adapted physical activity, therapeutic education and psychosocial support |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Muscle Your Heart home-based program | Other | 2 one-hour sessions of adapted physical activity per week - HIIT and free adapted physical activity - 1 one-hour monthly therapeutic patient education session - A dedicated platform - Adapted physical activity educators - Dedicated education therapeutic nurses |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the maximal oxygen consumption (VO2max) obtained in the cardiopulmonary exercise test (CPET) | baseline and at the end of the 3-month program (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| First ventilatory anaerobic threshold obtained at the CPET | at week 0 and at week 14 (last visit after the end of the rehabilitation program) | |
| Ventilatory efficiency (VE/VCO2 slope) obtained at the CPET | at week 0 and at week 14 (last visit after the end of the rehabilitation program) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pr Pascal AMEDRO, MD,PhD | Contact | 5 57 65 61 09 | 33 | pascal.amedro@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pr Pascal AMEDRO, MD,PhD | CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque | Pessac | France | 33604 | France |
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| Label | URL |
|---|---|
| Amedro, P., Gavotto, A., Guillaumont, S., Bertet, H., Vincenti, M., De La Villeon, G., et al. (2018). Cardiopulmonary fitness in children with congenital heart diseases versus healthy children. Heart (British Cardiac Society), 104(12), 1026-1036. | View source |
| Amedro, P., Dorka, R., Moniotte, S., Guillaumont, S., Fraisse, A., Kreitmann, B., et al. (2015). Quality of Life of Children with Congenital Heart Diseases: A Multicenter Controlled Cross-Sectional Study. Pediatric cardiology, 36(8), 1588-1601. | View source |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| Maximum oxygen pulse obtained at the CPET | at week 0 and at week 14 (last visit after the end of the rehabilitation program) |
| Maximum workload in watt obtained at the CPET | at week 0 and at week 14 (last visit after the end of the rehabilitation program) |
| Quality of life assessed with Pediatric Quality of Life questionnaire (PedsQL) questionnaire (self and proxy) | This is a validated questionnaire for patients aged between 2 and 25, comprising 23 items covering 4 different areas: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and academic functioning (5 items). The proxy questionnaire, designed for parents and those close to the child, assesses parents' perceptions of the quality of life associated with their child's state of health. Each item is scored from 0, when there is no problem, to 4, when there is always a problem. | at week 0 and at week 14 |
| Level of physical activity assessed with questionnaires for 8 to 17-year-old | The questionnaire for children aged 8 to 17 years included is the CAPAS-Q (Children and adolescents physical activity and sedentary questionnaire). The CAPAS-Q was developed as a clinical and field tool to provide indicators of physical activity and sedentary behaviour. The CAPAS-Q allows indicators such as the duration and intensity of physical activity to be addressed in different contexts (school, outside school, sports and leisure activities, transport). Physical activity is scored from 1 (inactive) to 4 (very active) and sedentary lifestyle is scored from 1 (not sedentary, active enough) from 6 (sedentary). | at week 0 and at week 13 |
| Level of physical activity assessed with questionnaires for over 18-year-old | For patients over 18 years of age, the short version of the IPAQ (International physical activity questionnaire) was chosen. This questionnaire assesses overall physical activity and sedentary behaviour over the last 7 days. The questionnaire looks at vigorous and moderate activity, walking, and time spent sitting (sedentary lifestyle), whether during leisure activities, at work, in daily life or on public transport. The questionnaire classifies the subject according to 3 levels of activity: inactive, moderate, high. | at week 0 and at week 13 |
| Level of physical activity assessed with accelerometers and questionnaires | Patients will wear an accelerometer for 7 days, to objectively measure their level of physical activity. This tool must be removed during aquatic activities or during activities involving physical contact. | at week 0 and at week 13 |
| Muscle strength of the upper limbs assessed by handgrip test | The Handgrip test consists of squeezing the handle of a hand dynamometer. The patient chooses their preferred hand and squeezes the handle as hard as they can for 3 seconds. The task was repeated 3 times, with 30 seconds rest between trials. The best trial is used as an indicator of maximum upper limb strength. | at week 0 and at week 14 |
| Muscle strength of lower limbs assessed Standing long jump test | For the lower limbs, the Standing long jump test is used. The patient stands with feet together and jumps forward as far as possible. After the jump, the patient must remain motionless with both feet on the ground. If he loses his balance or touches an object, he must repeat the jump. The distance between the jump line and the heels is measured. The patient performs 2 trials, the longest distance being used as an indicator of maximum lower limb strength. | at week 0 and at week 14 |
| Amedro, P., Picot, M. C., Moniotte, S., Dorka, R., Bertet, H., Guillaumont, S., et al. (2016). Correlation between cardio-pulmonary exercise test variables and health-related quality of life among children with congenital heart diseases. International | View source |
| Longmuir, P. E., \& McCrindle, B. W. (2009). Physical activity restrictions for children after the Fontan operation: disagreement between parent, cardiologist, and medical record reports. American heart journal, 157(5), 853-859 | View source |
| Swan, L., \& Hillis, W. S. (2000). Exercise prescription in adults with congenital heart disease: a long way to go. Heart (British Cardiac Society), 83(6), 685-687 | View source |
| Craig, C. L., Marshall, A. L., Sjöström, M., Bauman, A. E., Booth, M. L., Ainsworth, B. E., Pratt, M., et al. (2003). International physical activity questionnaire: 12-country reliability and validity. Medicine and science in sports and exercise, 35(8 | View source |
| Hagströmer, M., Oja, P., \& Sjöström, M. (2006). The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public health nutrition, 9(6), 755-762 | View source |
| Wind, A. E., Takken, T., Helders, P. J., \& Engelbert, R. H. (2010). Is grip strength a predictor for total muscle strength in healthy children, adolescents, and young adults?. European journal of pediatrics, 169(3), 281-287 | View source |
| Castro-Piñero, J., Ortega, F. B., Artero, E. G., Girela-Rejón, M. J., Mora, J., Sjöström, M., \& Ruiz, J. R. (2010). Assessing muscular strength in youth: usefulness of standing long jump as a general index of muscular fitness. Journal of strength and | View source |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |