Respiratory Muscle Training in CF Patients

Study Overview
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Brief Summary
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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.

Official Title
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Respiratory Muscle Training in Patients With Cystic Fibrosis

Conditions
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Cystic Fibrosis, Respiratory Muscles

Intervention / Treatment
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* Other: Endurance respiratory muscle training
* Other: Resistance inspiratory muscle training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endurance respiratory muscle training<br>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<br>* Training program of the respiratory muscles in endurance by using sustained isocapnic hyperpnea<br>|
| Active Comparator: Resistance inspiratory muscle training<br>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<br>* Training program of the inspiratory muscles in resistance by using repeated inspiratory maneuvers against a resistance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory muscle endurance | 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 | 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 | 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 | Score obtained during the questionnaire CQF14+ | Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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training, exercise, quality of life