Self Drainage in Pediatric Cystic Fibrosis Patients

NCT ID: NCT01509235

Last Updated: 2012-05-08

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-03-31

Brief Summary

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In the current study, we designed a cross-over, open label, randomized controlled clinical trial that aim to investigate the superiority of physical exercise coupled with self drainage to a chest physiotherapy in stable cystic fibrosis children. We hypothesized that CF children undergoing physical exercise coupled to self drainage will increase the amount of expectorate secretions compared to conventional CP course, while being more satisfied and without worsening their pulmonary function status.

Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1. Exercise testing and self drainage session

Group Type EXPERIMENTAL

Chest physiotherapy

Intervention Type PROCEDURE

The whole exercise session consisted of three short period of exercise of 5 minutes each entirely done under the physiotherapists' supervision (FA).

2. Chest physiotherapy (CP) session

Group Type ACTIVE_COMPARATOR

Chest physiotherapy

Intervention Type PROCEDURE

The whole exercise session consisted of three short period of exercise of 5 minutes each entirely done under the physiotherapists' supervision (FA).

Interventions

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Chest physiotherapy

The whole exercise session consisted of three short period of exercise of 5 minutes each entirely done under the physiotherapists' supervision (FA).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Cystic fibrosis diagnosis confirmed by 2 positive sudoriparous diagnostic tests
* Age : 7 to 17 years
* Capacity to expectorate
* Clinically stable
* Ability to pedal on a bike and to respect orders for physical session

Exclusion Criteria

* Haemoptysis \> 50ml
* Permanent non-invasive ventilation
* Respiration or digestive evolutive clinical abnormality
* Exacerbation
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabriel Bellon, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

References

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Reix P, Aubert F, Werck-Gallois MC, Toutain A, Mazzocchi C, Moreux N, Bellon G, Rabilloud M, Kassai B. Exercise with incorporated expiratory manoeuvres was as effective as breathing techniques for airway clearance in children with cystic fibrosis: a randomised crossover trial. J Physiother. 2012;58(4):241-7. doi: 10.1016/S1836-9553(12)70125-X.

Reference Type DERIVED
PMID: 23177226 (View on PubMed)

Other Identifiers

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2005.403

Identifier Type: -

Identifier Source: org_study_id

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