Respiratory Muscle Training in CF Patients

Cystic Fibrosis Clinical Trial

— MUCOMUREE  

Official title:

Respiratory Muscle Training in Patients With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03190031
• Other study ID #: 2016-A01652-49
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Respiratory Muscles

Intervention

Other:
• Endurance respiratory muscle training
Training program of the respiratory muscles in endurance by using sustained isocapnic hyperpnea
• Resistance inspiratory muscle training
Training program of the inspiratory muscles in resistance by using repeated inspiratory maneuvers against a resistance

Locations

Country	Name	City	State
France	University Hospital	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)