Respiratory Muscle Training in CF Patients

NCT03190031 | Completed

• 1 other identifier: 2016-A01652-49
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; Respiratory Muscles

Keywords

training; exercise; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Respiratory muscle strength

  Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)

• Maximal cycling performance

  Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)

• Quality of life of patients after the intervention

  Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1)

Study Arms (2)

Endurance respiratory muscle training

EXPERIMENTAL

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

Resistance inspiratory muscle training

ACTIVE COMPARATOR

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

Interventions

Endurance respiratory muscle training OTHER

Training program of the respiratory muscles in endurance by using sustained isocapnic hyperpnea

Endurance respiratory muscle training

Resistance inspiratory muscle training OTHER

Training program of the inspiratory muscles in resistance by using repeated inspiratory maneuvers against a resistance

Resistance inspiratory muscle training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital

Grenoble, 38000, France

Location

Related Publications (1)

• 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.

  PMID: 33331663 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 16, 2017
• Study Start: February 1, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)