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

NCT06184763 | Unknown

• 2 other identifiers: 23-5232Easydore
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Other: 6-minute walk test

Interventions

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.

ELEXACAFTOR/TEZACAFTOR/ IVACAFTOR treated patients

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort: cystic fibrosis patients followed in the respiratory diseases department of the Renee Sabran Hospital (approximately 100 patients)

You may qualify if:

• 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
• minute walked test performed in the year preceding initiation of ELEXACAFTOR / TEZACAFTOR/ IVACAFTOR
• minute walked test performed after treatment initiation (between the 3rd month and the 14th month)
• No opposition to participation

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Giens, 83406, France

Location

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 28, 2023
• Study Start: August 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2024
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)