Evolution of the 6-minute Walk Test in Patients Treated With ELEXACAFTOR / TEZACAFTOR / IVACAFTOR
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- distance walked in the 6-minute walk test (metres)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- Age < 12 years
- •Pregnancy
- •Discontinuation or reduction in dosage of ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR
- •Patients objecting to the use of their data for research purposes
结局指标
主要结局
distance walked in the 6-minute walk test (metres)
时间窗: between the 3rd month and the 14th month post treatment initiation
Distance walked in the 6-minute walk test, compared before and after the introduction of ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR.
次要结局
未报告次要终点