Prognosis Contribution of the 6 Minute Walk Test in Cystic Fibrosis : Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 2
- 主要终点
- Survival without lung transplant
研究概览
简要总结
The purpose of this study is to determine whether the 6-minute walk test (6MWT) could be a prognostic factor for cystic fibrosis patients.
详细描述
The 6-minute walk test is a simple exercise test, reproducing a daily physical activity. The utility of this test is described in several chronic lung diseases (chronic obstructive pulmonary disease, idiopathic pulmonary arterial hypertension). The distance performed during the 6MWT and / or desaturation during the 6MWT is a prognostic factor that contributes to the assessment of patients for lung transplantation indication.
The 6MWT is practiced routinely in cystic fibrosis centers but its usefulness in this disease has not been shown. Also the results of this test are not part of the decision-making criteria for lung transplantation.
A single-center study performed in adults CRCM at Cochin Hospital suggests the prognostic value of the 6MWT in patients with adult's cystic fibrosis.
The principal objective of this study is to assess the prognostic of 6MWT as part of the cystic fibrosis. The primary endpoint will be to assess the survival without lung transplant during the follow up period of 3 years. In this context, this prognostic tool could be used to help to determine the best time to consider a lung transplant in cystic fibrosis patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Cystic Fibrosis (bronchiectasis with presence of two mutations in the CFTR gene and / or positive sweat test.
- •Patients aged 18 year or older.
- •Pre-bronchodilator FEV1 FEV1 ≤ 60% from theoretical value: this FEV1 limits is proposed following the results from our published study (Martin et al. 2013) showing that desaturation during 6MWT and a distance ≤ 475m performed, are almost exclusively found in patients with FEV1 ≤ 60% .
- •Stable health status ( >15 days after the start of treatment of a respiratory exacerbation
- •No indications against the walking test:
- •Left uncontrolled heart failure Severe aortic stenosis acute endocarditis syncope Symptomatic severe arrhythmia stable angina Myocardial infarction <5 days Acute respiratory distress Resting SpO2≤85% pulmonary edema Uncontrolled asthma Arterial or venous thrombosis of the lower limbs, Severe acute condition that may interfere with the exercise performance (infections, renal failure, hyperthyroidism, unable to cooperate, severe pulmonary arterial hypertension, severe systemic blood pressure (Systolic blood pressure >200 mm Hg and / or diastolic blood pressure >120 mm Hg))
排除标准
- •History of lung transplant
- •Oxygen Dependence (inability to achieve a 6-minute walk test in ambient air)
- •Any indication against walk test
- •Pregnant women, persons deprived of liberty, person under guardianship, person in emergency situation
- •Person not affiliated to social security system
- •Refusal to participate in the study
结局指标
主要结局
Survival without lung transplant
时间窗: 3 years
次要结局
- distance traveled during the 6MWT(one day)
- Oxygen desaturation (SpO2<90%) measured by a plethysmography exam during the 6MWT(one day)
- Number of days of intravenous antibiotic therapy(3 years)
- Dyspnea questionnaire (mMRC scale)(once a year during 3 years)
- Measure of the Quality of life (Cystic Fibrosis Questionnaire 14+, SF12)(once a year during 3 years)
- Measure of Anxiety and Depression (Hospital Anxiety Depression HAD scale)(once a year during 3 years)
- Measure of the Physical activity (Baecke questionnaire)(once a year during 3 years)