Effects of AD on VI in Patients With CF

Not Applicable

Recruiting

• Conditions: Cystic Fibrosis
• Interventions: Other: Autogenic drainage; Drug: Aerosoltherapy

• Registration Number: NCT03655249
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Asl + CPT	Autogenic drainage	Aerosotherapy + Autogenic drainage
Asl	Aerosoltherapy	Aerosoltherapy alone
Asl + CPT	Aerosoltherapy	Aerosotherapy + Autogenic drainage

Primary Outcome Measures

Name	Time	Method
Change in Lung Clearance Index	Up to 2 weeks	LCI will be measured before, immediately after and 2h after the experimental or control conditions as well as before and after an hospitalization.

Secondary Outcome Measures

Name	Time	Method
Impedance variation	Up to 1 hour	Impedance change in different lung zones

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium