Cystic Fibrosis
Conditions
Keywords
Cystic Fibrosis, Exercise Testing, Muscular strength, Pediatrics, Quality of life
Brief summary
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.
Interventions
BEHAVIORALSit-to-stand test
CF young patients will perform 2 STS tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored.
BEHAVIORAL6-Minute Walk Test
CF young patients will perform 2 6MWT tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored.
Sponsors
Groupe Hospitalier du Havre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between number of repetitions (STS Test) and 6-Minute Walking Distance | This outcome will be measured after both tests realization up to 15 minutes. | Comparison between the results of these two submaximal exercise tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between number of repetitions (STS test) and Maximal Expiratory Pressure (MEP) | MEP will be measured after inclusion in the hour before field tests realization. | MEP will be assessed using a MicroRPM Puma manometer. |
| Correlation between number of repetitions (STS Test) and health-related quality of life | HRQoL testing will be carried out after inclusion in the hour before field tests realization. | HRQoL will be measured by the Cystic Fibrosis Questionnaire |
| Correlation between number of repetitions (STS Test) and quadriceps strength. | Quadriceps strength will be assessed after inclusion in the hour before field tests realization. | Quadriceps strength will be assessed by handheld dynamometry using a MicroFet II dynamometer. |
| Correlation between number of repetitions (STS Test) and forced vital capacity (FVC) | Spirometric test will be carried out before field tests realization. | FVC will be assessed with non invasive spirometry. |
| Correlation between number of repetitions (STS Test) and forced expiratory volume in 1 second (FEV1) | Spirometric test will be carried out in the last 3 months before field tests realization. | FEV1 will be assessed with non invasive spirometry. |
| Correlation between number of repetitions (STS test) and Maximal Inspiratory Pressure (MIP) | MIP will be measured after inclusion in the hour before field tests realization. | MIP will be assessed using a microRPM Puma manometer. |
| Differences in dyspnea and muscular fatigue. | 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. | These outcomes will be assessed using Modified Borg Scale (0-10 points) |
| Differences in Heart Rate. | 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. | These outcomes will be assessed using pulse oximetry. |
| Differences in Respiratory Rate. | 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 | These outcomes will be assessed using pulse oximetry. |
| Differences in Oxygen Saturation. | 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. | These outcomes will be assessed using pulse oximetry. |
| 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. | — |
Countries
France
Outcome results
None listed