6 Minute Walk Test in Cystic Fibrosis

NCT02538575 | Completed

• 1 other identifier: 2015-A00387-42
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Adults; 6-minute walk test

Outcome Measures

Primary Outcomes (1)

• Survival without lung transplant

  3 years

Secondary Outcomes (7)

• 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

Study Arms (1)

6-minute walk test

EXPERIMENTAL

Other: 6-minute walk test

Interventions

6-minute walk test OTHER

a walk of 6 minutes repeated twice in an interval of 30 minutes

6-minute walk test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Data analysis : EFFI-STAT (statistic expert): collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator
• Funding : Association Vaincre La Mucoviscidose: collaborator

Study Sites (1)

Hôpital Cochin, service de pneumologie

Paris, Paris, 75014, France

Location

Related Publications (3)

• 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.

  PMID: 24157200 BACKGROUND

• 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.

  PMID: 25359355 BACKGROUND

• 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.

  PMID: 25359356 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

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

Study Officials

• Pierre-Regis BURGEL, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 2, 2015
• Study Start: May 12, 2016
• Primary Completion: December 6, 2018
• Study Completion: September 18, 2020
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)