Clinical trial NCT02538575: 6 Minute Walk Test in Cystic Fibrosis
Official title: Prognosis Contribution of the 6 Minute Walk Test in Cystic Fibrosis : Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Adults
6-minute walk test
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Data analysis : EFFI-STAT (statistic expert)
name: URC-CIC Paris Descartes Necker Cochin
name: Funding : Association Vaincre La Mucoviscidose
First posted: 2015-09-02
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether the 6-minute walk test (6MWT) could be a prognostic factor for cystic fibrosis patients.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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))

Exclusion Criteria:

* 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

Primary outcomes:
measure: Survival without lung transplant
timeFrame: 3 years
Secondary outcomes:
measure: distance traveled during the 6MWT
timeFrame: one day
measure: Oxygen desaturation (SpO2<90%) measured by a plethysmography exam during the 6MWT
timeFrame: one day
measure: Number of days of intravenous antibiotic therapy
timeFrame: 3 years
measure: Dyspnea questionnaire (mMRC scale)
timeFrame: once a year during 3 years
measure: Measure of the Quality of life (Cystic Fibrosis Questionnaire 14+, SF12)
timeFrame: once a year during 3 years
measure: Measure of Anxiety and Depression (Hospital Anxiety Depression HAD scale)
timeFrame: once a year during 3 years
measure: Measure of the Physical activity (Baecke questionnaire)
timeFrame: once a year during 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin, service de pneumologie
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pierre-Regis BURGEL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin C, Chapron J, Hubert D, Kanaan R, Honore I, Paillasseur JL, Aubourg F, Dinh-Xuan AT, Dusser D, Fajac I, Burgel PR. Prognostic value of six minute walk test in cystic fibrosis adults. Respir Med. 2013 Dec;107(12):1881-7. doi: 10.1016/j.rmed.2013.10.001. Epub 2013 Oct 11.
citation: Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
citation: Singh SJ, Puhan MA, Andrianopoulos V, Hernandes NA, Mitchell KE, Hill CJ, Lee AL, Camillo CA, Troosters T, Spruit MA, Carlin BW, Wanger J, Pepin V, Saey D, Pitta F, Kaminsky DA, McCormack MC, MacIntyre N, Culver BH, Sciurba FC, Revill SM, Delafosse V, Holland AE. An official systematic review of the European Respiratory Society/American Thoracic Society: measurement properties of field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1447-78. doi: 10.1183/09031936.00150414. Epub 2014 Oct 30.