Respiratory Muscle Training in CF Patients

NCT ID: NCT03190031

Last Updated: 2020-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2019-12-30

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.

Detailed Description

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Conditions

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Cystic Fibrosis Respiratory Muscles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Endurance respiratory muscle training

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Resistance inspiratory muscle training

Intervention Type OTHER

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

Interventions

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Endurance respiratory muscle training

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

Intervention Type OTHER

Resistance inspiratory muscle training

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital

Grenoble, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 33331663 (View on PubMed)

Other Identifiers

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2016-A01652-49

Identifier Type: -

Identifier Source: org_study_id

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