Back to results

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

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

6-minute walk test

About this trial

This is an interventional other trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Adults, 6-minute walk test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Cochin, service de pneumologie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

6-minute walk test

Arm Description

Outcomes

Primary Outcome Measures

Survival without lung transplant

Secondary Outcome Measures

distance traveled during the 6MWT

Oxygen desaturation (SpO2<90%) measured by a plethysmography exam during the 6MWT

Number of days of intravenous antibiotic therapy

Dyspnea questionnaire (mMRC scale)

Measure of the Quality of life (Cystic Fibrosis Questionnaire 14+, SF12)

Measure of Anxiety and Depression (Hospital Anxiety Depression HAD scale)

Measure of the Physical activity (Baecke questionnaire)

Full Information

NCT ID

NCT02538575

First Posted

August 31, 2015

Last Updated

July 31, 2021

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02538575

Brief Title

6 Minute Walk Test in Cystic Fibrosis

Acronym

MUCO-TM6

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

May 12, 2016 (Actual)

Primary Completion Date

December 6, 2018 (Actual)

Study Completion Date

September 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

Cystic Fibrosis, Adults, 6-minute walk test

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

291 (Actual)

8. Arms, Groups, and Interventions

Arm Title

6-minute walk test

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

6-minute walk test

Intervention Description

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

Primary Outcome Measure Information:

Title

Survival without lung transplant

Time Frame

3 years

Secondary Outcome Measure Information:

Title

distance traveled during the 6MWT

Time Frame

one day

Title

Oxygen desaturation (SpO2<90%) measured by a plethysmography exam during the 6MWT

Time Frame

one day

Title

Number of days of intravenous antibiotic therapy

Time Frame

3 years

Title

Dyspnea questionnaire (mMRC scale)

Time Frame

once a year during 3 years

Title

Measure of the Quality of life (Cystic Fibrosis Questionnaire 14+, SF12)

Time Frame

once a year during 3 years

Title

Measure of Anxiety and Depression (Hospital Anxiety Depression HAD scale)

Time Frame

once a year during 3 years

Title

Measure of the Physical activity (Baecke questionnaire)

Time Frame

once a year during 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre-Regis BURGEL, MD, PhD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Cochin, service de pneumologie

City

Paris

ZIP/Postal Code

75014

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24157200

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.

Results Reference

background

PubMed Identifier

25359355

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.

Results Reference

background

PubMed Identifier

25359356

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.

Results Reference

background

Learn more about this trial

6 Minute Walk Test in Cystic Fibrosis

We'll reach out to this number within 24 hrs