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

NCT ID: NCT06184763

Last Updated: 2023-12-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 73 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-11-01

Brief 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

Keywords

cystic fibrosis; CFTR modulators; 6-minutes walk test; physical activity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

6-minute walk test

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients aged ≥ 12 years with cystic fibrosis, heterozygous for the F508del mutation of the CFTR gene, treated with ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR.
• Patients followed in the respiratory diseases department of the Renee Sabran Hospital
• 6-minute walked test performed in the year preceding initiation of ELEXACAFTOR / TEZACAFTOR/ IVACAFTOR
• 6-minute walked test performed after treatment initiation (between the 3rd month and the 14th month)
• No opposition to participation

Exclusion Criteria

• - Age < 12 years
• Pregnancy
• Discontinuation or reduction in dosage of ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR
• Patients objecting to the use of their data for research purposes

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Respiratory diseases department, Renee Sabran Hospital (Hospices civils de Lyon)

Giens, , France

Countries

France

Other Identifiers

Easydore

Identifier Type: OTHER

Identifier Source: secondary_id

23-5232

Identifier Type: -

Identifier Source: org_study_id