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| ID | Type | Description | Link |
|---|---|---|---|
| Easydore | Other Identifier | 69HCL23_1322 |
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The aim of the study is to identify a link between the new CFTR modulators and physical activity in cystic fibrosis patients.
The triple combination of CFTR modulators (ELEXACAFTOR / TEZACAFTOR/ IVACAFTOR) has recently changed the management of cystic fibrosis.
This treatment has been shown to rapidly improve patients' respiratory function, with a gain in FEV1 at 1 month ranging from 10.4% to 13.6%. It also reduces the number of respiratory exacerbations and improves the nutritional status and quality of life of treated patients.
To date, there is limited data on the impact of these new therapies on physical activity. Few studies have investigated changes in exercise or physical activity parameters under ELEXACAFTOR / TEZACAFTOR/ IVACAFTOR.
The 6-minute walk test is a validated field test used routinely to assess the exercise capacity of patients with chronic respiratory diseases, including cystic fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ELEXACAFTOR/TEZACAFTOR/ IVACAFTOR treated patients | Patients ≥ 12 years old with cystic fibrosis followed at the Renee Sabran Hospital, heterozygous for the F508del mutation of the CFTR gene, treated with ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR. Intervention: 6-minute walk test before and after starting treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6-minute walk test | Other | 6-minute walk test in a 40-metre corridor. Included patients are used to performing this test, which is part of the standard care performed during patient follow-up, at least once a year. Parameters collected during the test: distance walked, minimum SpO2, average SpO2, maximum heart rate, average heart rate, average heart rate over the last 2 minutes, dyspnea scale. |
| Measure | Description | Time Frame |
|---|---|---|
| distance walked in the 6-minute walk test (metres) | Distance walked in the 6-minute walk test, compared before and after the introduction of ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR. | between the 3rd month and the 14th month post treatment initiation |
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Inclusion Criteria:
Exclusion Criteria:
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Cohort: cystic fibrosis patients followed in the respiratory diseases department of the Renee Sabran Hospital (approximately 100 patients)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory diseases department, Renee Sabran Hospital (Hospices civils de Lyon) | Giens | 83406 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40414317 | Derived | Perrone J, Rabilloud M, Mely L. Change in the 6-min walk test among 71 patients with cystic fibrosis treated with elexacaftor/tezacaftor/ivacaftor. Respir Med. 2025 Aug;244:108178. doi: 10.1016/j.rmed.2025.108178. Epub 2025 May 23. |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D001519 | Behavior |