Respiratory Muscle Training in CF Patients (MUCOMUREE)

March 19, 2020 updated by: University Hospital, Grenoble

Respiratory Muscle Training in Patients With Cystic Fibrosis

The present study aims at evaluating the effect of respiratory muscle training in adult patients with cystic fibrosis on lung function, exercise performance and quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

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
      • Grenoble, France, 38000
        • University Hospital

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 to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a clinical diagnosis of cystic fibrosis
  • Patients in steady state

Exclusion Criteria:

  • Patients during exacerbation
  • Patients treated by oral corticotherapy (>0.5 mg/kg/j during >7 days) during the past 2 months
  • Pregnant patients

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endurance respiratory muscle training
The intervention consists in performing isocapnic hyperpnea at 70-80% of maximal voluntary ventilation for 20 min, 5 times a week, for 8 weeks
Other: Endurance respiratory muscle training
Training program of the respiratory muscles in endurance by using sustained isocapnic hyperpnea
Active Comparator: Resistance inspiratory muscle training
The intervention consists in performing inspiratory resistive breathing at 70-80% of maximal inspiratory pressure for 20 min, 5 times a week, for 8 weeks
Other: Resistance inspiratory muscle training
Training program of the inspiratory muscles in resistance by using repeated inspiratory maneuvers against a resistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory muscle endurance
Time Frame: Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)
Total breathing duration (in min) measured during an incremental hyperpnea test
Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory muscle strength
Time Frame: Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)
Peak pressure (in mmHg) during maximal inspiratory and expiratory maneuvers
Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)
Maximal cycling performance
Time Frame: Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)
Peak maximal power output (in W) during an incremental cycling test
Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)
Quality of life of patients after the intervention
Time Frame: Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)
Score obtained during the questionnaire CQF14+
Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

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)

February 1, 2017

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

June 15, 2017

First Posted (Actual)

June 16, 2017

Study Record Updates

Last Update Posted (Actual)

March 23, 2020

Last Update Submitted That Met QC Criteria

March 19, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A01652-49

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

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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