NCT06184763

Evolution of the 6-minute Walk Test in Patients Treated With ELEXACAFTOR / TEZACAFTOR / IVACAFTOR

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 73 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
OTHER	6-minute walk test	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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2023-11-01
• Completion: 2024-11-01
• First posted: 2023-12-28
• Last updated: 2023-12-28

Locations

1 site across 1 country: France