Sit-to-stand Test in Cystic Fibrosis Children and Adolescents

Study Overview
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Brief Summary
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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.

Official Title
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Sit-to-stand Test Use in Children and Adolescents With Cystic Fibrosis : Correlations With 6-Minute Walking Test, Quadriceps and Respiratory Muscle Strength and Health Related Quality of Life

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Behavioral: Sit-to-stand test
* Behavioral: 6-Minute Walk Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cystic Fibrosis Exacerbation-free last month before inclusion Exclusion Criteria: Cardiovascular, neurological or musculoskeletal contra-indications to exercise testing Other respiratory disease (kyphoscoliosis, asthma ...) Exacerbation Unability to carry out field tests

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sit-to-stand test<br>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. | Behavioral: Sit-to-stand test<br>* CF young patients will perform 2 STS tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored.<br>|
| Active Comparator: 6-Minute Walk Test<br>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. | Behavioral: 6-Minute Walk Test<br>* CF young patients will perform 2 6MWT tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis, Exercise Testing, Muscular strength, Pediatrics, Quality of life