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Cystic fibrosis (CF) is a chronic hereditary respiratory disease. Exercise testing is part of CF patients regular assessment.
Cardio-Pulmonary Exercise Testing (CPET) is currently considered as the gold standard to assess physical capacities. However, simple field tests are emerging. These tests are easier to perform especially in a population of CF children and adolescents.
The 1minute Sit-To-Stand test have recently been evaluated in CF adults. This test correlates with maximal oxygen consumption during CPET.
The investigators hypothesized that this test also correlates with 6-Minute Walking distance (during a 6-min Walk Test), quadriceps strength, respiratory muscles strength and health-related quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sit-to-stand test | Experimental | Children and adolescents will perform 2 STS tests. First one is used to eliminate learning effect. Number of repetitions will be noted at the end of the second test. |
|
| 6-Minute Walk Test | Active Comparator | Children and adolescents will perform 2 6MWT tests. First one is used to eliminate learning effect. Number of repetitions will be noted at the end of the second test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sit-to-stand test | Behavioral | CF young patients will perform 2 STS tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between number of repetitions (STS Test) and 6-Minute Walking Distance | Comparison between the results of these two submaximal exercise tests | This outcome will be measured after both tests realization up to 15 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between number of repetitions (STS test) and Maximal Inspiratory Pressure (MIP) | MIP will be assessed using a microRPM Puma manometer. | MIP will be measured after inclusion in the hour before field tests realization. |
| Correlation between number of repetitions (STS test) and Maximal Expiratory Pressure (MEP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pascal Le Roux, MD | Groupe Hospitalier du Havre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Côte de Nacre | Caen | France | ||||
| Le Havre Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26363563 | Background | Radtke T, Puhan MA, Hebestreit H, Kriemler S. The 1-min sit-to-stand test--A simple functional capacity test in cystic fibrosis? J Cyst Fibros. 2016 Mar;15(2):223-6. doi: 10.1016/j.jcf.2015.08.006. Epub 2015 Sep 9. | |
| 16806873 | Background | Ozalevli S, Ozden A, Itil O, Akkoclu A. Comparison of the Sit-to-Stand Test with 6 min walk test in patients with chronic obstructive pulmonary disease. Respir Med. 2007 Feb;101(2):286-93. doi: 10.1016/j.rmed.2006.05.007. Epub 2006 Jun 27. |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| 6-Minute Walk Test | Behavioral | CF young patients will perform 2 6MWT tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored. |
|
MEP will be assessed using a MicroRPM Puma manometer. |
| MEP will be measured after inclusion in the hour before field tests realization. |
| Correlation between number of repetitions (STS Test) and health-related quality of life | HRQoL will be measured by the Cystic Fibrosis Questionnaire | HRQoL testing will be carried out after inclusion in the hour before field tests realization. |
| Correlation between number of repetitions (STS Test) and quadriceps strength. | Quadriceps strength will be assessed by handheld dynamometry using a MicroFet II dynamometer. | Quadriceps strength will be assessed after inclusion in the hour before field tests realization. |
| Correlation between number of repetitions (STS Test) and forced vital capacity (FVC) | FVC will be assessed with non invasive spirometry. | Spirometric test will be carried out before field tests realization. |
| Correlation between number of repetitions (STS Test) and forced expiratory volume in 1 second (FEV1) | FEV1 will be assessed with non invasive spirometry. | Spirometric test will be carried out in the last 3 months before field tests realization. |
| Correlation between number of repetitions (STS Test) and number of exacerbations / year. | Number of exacerbations / year will assess the number of exacerbations in the last year before inclusion and will be assessed during the initial survey in the hour before field test realization. |
| Differences in dyspnea and muscular fatigue. | These outcomes will be assessed using Modified Borg Scale (0-10 points) | These outcomes will be assessed during both field tests. These tests will be separate by a 30 minutes rest period. Date will be collected at the end of each test up to 15 minutes. |
| Differences in Heart Rate. | These outcomes will be assessed using pulse oximetry. | These outcomes will be assessed during both field tests. These tests will be separate by a 30 minutes rest period. Date will be collected at the end of each test up to 15 minutes. |
| Differences in Respiratory Rate. | These outcomes will be assessed using pulse oximetry. | These outcomes will be assessed during both field tests. These tests will be separate by a 30 minutes rest period. Date will be collected at the end of each test up to 15 minutes |
| Differences in Oxygen Saturation. | These outcomes will be assessed using pulse oximetry. | These outcomes will be assessed during both field tests. These tests will be separate by a 30 minutes rest period. Date will be collected at the end of each test up to 15 minutes. |
| Le Havre |
| 76290 |
| France |
| CHU de Rouen | Rouen | 76000 | France |
| 15463817 | Background | Hussey J, Gormley J, Leen G, Greally P. Peripheral muscle strength in young males with cystic fibrosis. J Cyst Fibros. 2002 Sep;1(3):116-21. doi: 10.1016/s1569-1993(02)00074-7. |
| 33577586 | Derived | Combret Y, Boujibar F, Gennari C, Medrinal C, Sicinski S, Bonnevie T, Gravier FE, Laurans M, Marguet C, Le Roux P, Lamia B, Prieur G, Reychler G. Measurement properties of the one-minute sit-to-stand test in children and adolescents with cystic fibrosis: A multicenter randomized cross-over trial. PLoS One. 2021 Feb 12;16(2):e0246781. doi: 10.1371/journal.pone.0246781. eCollection 2021. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |