6 Minute Walk Test in Cystic Fibrosis (MUCO-TM6)

November 17, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Prognosis Contribution of the 6 Minute Walk Test in Cystic Fibrosis : Prospective Multicenter Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

291

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Paris
      • Paris, Paris, France, 75014
        • Hôpital Cochin, service de pneumologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 6-minute walk test
Other: 6-minute walk test
a walk of 6 minutes repeated twice in an interval of 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival without lung transplant
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
distance traveled during the 6MWT
Time Frame: one day
one day
Oxygen desaturation (SpO2<90%) measured by a plethysmography exam during the 6MWT
Time Frame: one day
one day
Number of days of intravenous antibiotic therapy
Time Frame: 3 years
3 years
Dyspnea questionnaire (mMRC scale)
Time Frame: once a year during 3 years
once a year during 3 years
Measure of the Quality of life (Cystic Fibrosis Questionnaire 14+, SF12)
Time Frame: once a year during 3 years
once a year during 3 years
Measure of Anxiety and Depression (Hospital Anxiety Depression HAD scale)
Time Frame: once a year during 3 years
once a year during 3 years
Measure of the Physical activity (Baecke questionnaire)
Time Frame: once a year during 3 years
once a year during 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Data analysis : EFFI-STAT (statistic expert)
URC-CIC Paris Descartes Necker Cochin
Funding : Association Vaincre La Mucoviscidose

Investigators

  • Principal Investigator: Pierre-Regis BURGEL, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2016

Primary Completion (Actual)

December 6, 2018

Study Completion (Actual)

September 18, 2020

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

August 31, 2015

First Posted (Estimated)

September 2, 2015

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A00387-42

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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