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Respiratory Muscle Training in CF Patients (MUCOMUREE)

Primary Purpose

Cystic Fibrosis, Respiratory Muscles

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endurance respiratory muscle training
Resistance inspiratory muscle training
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring training, exercise, quality of life

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endurance respiratory muscle training

Resistance inspiratory muscle training

Arm Description

The intervention consists in performing isocapnic hyperpnea at 70-80% of maximal voluntary ventilation for 20 min, 5 times a week, for 8 weeks

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

Outcomes

Primary Outcome Measures

Respiratory muscle endurance
Total breathing duration (in min) measured during an incremental hyperpnea test

Secondary Outcome Measures

Respiratory muscle strength
Peak pressure (in mmHg) during maximal inspiratory and expiratory maneuvers
Maximal cycling performance
Peak maximal power output (in W) during an incremental cycling test
Quality of life of patients after the intervention
Score obtained during the questionnaire CQF14+

Full Information

First Posted
June 12, 2017
Last Updated
March 19, 2020
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT03190031
Brief Title
Respiratory Muscle Training in CF Patients
Acronym
MUCOMUREE
Official Title
Respiratory Muscle Training in Patients With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Respiratory Muscles
Keywords
training, exercise, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients will be randomized in 2 different groups, one being involved in an endurance respiratory muscle training program, the other being involved in resistance inspiratory muscle training.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endurance respiratory muscle training
Arm Type
Experimental
Arm Description
The intervention consists in performing isocapnic hyperpnea at 70-80% of maximal voluntary ventilation for 20 min, 5 times a week, for 8 weeks
Arm Title
Resistance inspiratory muscle training
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Endurance respiratory muscle training
Intervention Description
Training program of the respiratory muscles in endurance by using sustained isocapnic hyperpnea
Intervention Type
Other
Intervention Name(s)
Resistance inspiratory muscle training
Intervention Description
Training program of the inspiratory muscles in resistance by using repeated inspiratory maneuvers against a resistance
Primary Outcome Measure Information:
Title
Respiratory muscle endurance
Description
Total breathing duration (in min) measured during an incremental hyperpnea test
Time Frame
Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)
Secondary Outcome Measure Information:
Title
Respiratory muscle strength
Description
Peak pressure (in mmHg) during maximal inspiratory and expiratory maneuvers
Time Frame
Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)
Title
Maximal cycling performance
Description
Peak maximal power output (in W) during an incremental cycling test
Time Frame
Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)
Title
Quality of life of patients after the intervention
Description
Score obtained during the questionnaire CQF14+
Time Frame
Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital
City
Grenoble
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33331663
Citation
Stanford G, Ryan H, Solis-Moya A. Respiratory muscle training for cystic fibrosis. Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD006112. doi: 10.1002/14651858.CD006112.pub5.
Results Reference
derived

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Respiratory Muscle Training in CF Patients

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