Cystic FibrosisMUCO-TM6NCT02538575
6 Minute Walk Test in Cystic Fibrosis
A study testing 6-minute walk test in people with Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- 6-minute walk test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2016to 18 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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))
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- 6-minute walk test
- Keywords
- Cystic Fibrosis, Adults, 6-minute walk test
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-minute walk testOther
a walk of 6 minutes repeated twice in an interval of 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 6-minute walk test | Experimental | Not described Receives: Other: 6-minute walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival without lung transplant
Measured: 3 years
Secondary outcomes (7)
distance traveled during the 6MWT
Measured: one day
Oxygen desaturation (SpO2<90%) measured by a plethysmography exam during the 6MWT
Measured: one day
Number of days of intravenous antibiotic therapy
Measured: 3 years
Dyspnea questionnaire (mMRC scale)
Measured: once a year during 3 years
Measure of the Quality of life (Cystic Fibrosis Questionnaire 14+, SF12)
Measured: once a year during 3 years
Measure of Anxiety and Depression (Hospital Anxiety Depression HAD scale)
Measured: once a year during 3 years
Measure of the Physical activity (Baecke questionnaire)
Measured: once a year during 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study start12 May 2016
- Primary completion6 Dec 2018
- Study completion18 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Data analysis : EFFI-STAT (statistic expert), URC-CIC Paris Descartes Necker Cochin, Funding : Association Vaincre La Mucoviscidose
- Responsible party
- Sponsor
- Investigators
- Pierre-Regis BURGEL, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538575
- Sponsor's protocol ID
- 2015-A00387-42
- Acronym
- MUCO-TM6
- Status last verified
- Oct 2025
- First submitted
- 31 Aug 2015
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24157200Holland 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.
PubMed 25359355Singh 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.
PubMed 25359356
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis Contribution of the 6 Minute Walk Test in Cystic Fibrosis : Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT02538575
- Acronym / sponsor ID
- MUCO-TM6 / 2015-A00387-42
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Adults, 6-minute walk test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Data analysis : EFFI-STAT (statistic expert), URC-CIC Paris Descartes Necker Cochin, Funding : Association Vaincre La Mucoviscidose
- Study start
- 12 May 2016 (actual)
- Primary completion
- 6 Dec 2018 (actual)
- Study completion
- 18 Sep 2020 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 6-minute walk test | Experimental | Other: 6-minute walk test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-minute walk testa walk of 6 minutes repeated twice in an interval of 30 minutes | Other | 6-minute walk test |
Primary outcome
Survival without lung transplant
Time frame: 3 years
7 secondary outcomes
distance traveled during the 6MWT
Time frame: one day
Oxygen desaturation (SpO2<90%) measured by a plethysmography exam during the 6MWT
Time frame: one day
Number of days of intravenous antibiotic therapy
Time frame: 3 years
Dyspnea questionnaire (mMRC scale)
Time frame: 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
Measure of Anxiety and Depression (Hospital Anxiety Depression HAD scale)
Time frame: once a year during 3 years
Measure of the Physical activity (Baecke questionnaire)
Time frame: once a year during 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 24157200Martin 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.
- Background: PubMed 25359355Holland 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.
- Background: PubMed 25359356Singh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Regis BURGEL, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6-minute walk test in people with Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival without lung transplant (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02538575, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.