Effects of AD on VI in Patients With CF

NCT ID: NCT03655249

Last Updated: 2024-07-01

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

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2025-12-31

Brief Summary

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This study will investigate the effects of a chest physiotherapy manual technique (autogenic drainage) on ventilation inhomogeneity in patients with cystic fibrosis. Lung clearance index (LCI) is the primary outcome

Detailed Description

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This is a cross-over intervention assessing the effect of autogenic drainage on ventilation inhomogeneity in patients with cystic fibrosis.

Electrical impedance tomography and multiple breath nitrogen washout will be performed before, immediatly after and 2h post intervention. Each participant will receive either aerosoltherapy alone or in combination with chest physiotherapy on 2 consecutive days.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants receive one of two interventions during the first day, and receive the alternative intervention the following day.

Interventions are : aerosoltherapy + autogenic drainage or aerosoltherapy alone
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Asl + CPT

Aerosotherapy + Autogenic drainage

Group Type EXPERIMENTAL

Autogenic drainage

Intervention Type OTHER

Autogenic drainage is an airway clearance technique that attempts to obtain the optimal airflow to evacuate the secretions. This technique uses modulation of inspiratory and expiratory airflow at different breathing level within the vital capacity.

Aerosoltherapy

Intervention Type DRUG

Aerosolized drugs are individualized for each participants, in line with current standardized practice in our hospital. Those drugs will not be modified for the purpose of this study.

Asl

Aerosoltherapy alone

Group Type ACTIVE_COMPARATOR

Aerosoltherapy

Intervention Type DRUG

Aerosolized drugs are individualized for each participants, in line with current standardized practice in our hospital. Those drugs will not be modified for the purpose of this study.

Interventions

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Autogenic drainage

Autogenic drainage is an airway clearance technique that attempts to obtain the optimal airflow to evacuate the secretions. This technique uses modulation of inspiratory and expiratory airflow at different breathing level within the vital capacity.

Intervention Type OTHER

Aerosoltherapy

Aerosolized drugs are individualized for each participants, in line with current standardized practice in our hospital. Those drugs will not be modified for the purpose of this study.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Cystic fibrosis diagnosis
* FEV1 \> 40%
* Able to sustain 30min of chest physiotherapy

Exclusion Criteria

* Presence of Burkoldheria cepacia or non tuberculous mycobacteria
* Orthopedic, neuromuscular or cardiac disorder likely to impact respiratory system
* Need for supplemental oxygen
* Cardiac pacemaker or internal cardiac defibrillator
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory Reychler, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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William Poncin, PT, PhD

Role: CONTACT

+3227642316

Gregory Reychler, PT, PhD

Role: CONTACT

+3227642316

Facility Contacts

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William Poncin

Role: primary

Other Identifiers

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2018/22FEV/079

Identifier Type: -

Identifier Source: org_study_id

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