Exercise and Oscillatory Positive Expiratory Pressure Therapy in Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Device: No Flutter®; Device: Flutter®

• Registration Number: NCT02750722
• Lead Sponsor: University of Zurich

Brief Summary

The investigators aim to compare a single bout of moderately intense cycling exercise incorporating Flutter® breathing maneuvers with a single bout of moderately intense cycling exercise alone on sputum viscoelasticity (primary endpoint) and the diffusion capacity of the lungs in adult patients with cystic fibrosis.

The investigators further aim to analyze the short-term variability of resting diffusion capacity of carbon monoxide (DLCO) and nitric oxide (DLNO) in patients with cystic fibrosis.

Detailed Description

Regular airway clearance is an integral component of cystic fibrosis care and of critical importance to lung health. Exercise and standardized chest physiotherapy are accepted airway clearance techniques in cystic fibrosis. Different airway clearance techniques are available, but there is no evidence that one technique or a combination is superior. Oscillatory positive expiratory pressure with the Flutter® is a widely used airway clearance technique in the European countries and has been shown to favourably alter sputum viscoelasticity in cystic fibrosis.

This randomized crossover study is designed to assess the acute effects of combined cycling exercise and Flutter® therapy on sputum viscoelasticity (primary outcome measure) and gas diffusion in adults with cystic fibrosis.

Study Timeline

• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-20
• Study First Posted: 2016-04-25
• Study Start: 2016-05
• Status Verified: 2017-01
• Primary Completion: 2017-01-19
• Study Completion: 2017-01-19
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Confirmed diagnosis of CF based on either two CF-causing mutations and/or a sweat chloride concentration during two tests of > 60 mmol/l
• Patients that are able to provide sputum samples
• Adult age ≥ 18 years

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Exclusion Criteria

• Unstable condition affecting participation in the exercise experiments (i.e., major hemoptysis or pneumothorax within the last 3 months, acute exacerbation and iv-antibiotics during the last 4 weeks, unstable allergic bronchopulmonary aspergillosis, listed for lung transplantation, major musculoskeletal injuries such as fractures or sprains during the last 2 months, others according to the impression of the doctor)
• Cardiac arrhythmias with exercise
• Requiring additional oxygen with exercise
• Colonization with Burkholderia cenocepacia
• Status post lung transplantation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cycling without Flutter® therapy	No Flutter®	Participants perform 30 minutes of continuous moderately intense cycling exercise at 75% of their maximal heart rate without additional Flutter® breathing maneuvers.
Cycling in combination with Flutter® therapy	Flutter®	Participants perform 30 minutes of moderately intense cycling exercise in 4-min intervals at 75% of their maximal heart rate and interspersed with 2-min resting periods during which 6-8 breathing maneuvers are performed with the Flutter®.

Primary Outcome Measures

Name	Time	Method
Change in sputum viscoelasticity (G*) over a broad frequency range (1-100 rad.s-1)	Baseline - immediately post exercise - 45min post exercise	Sputum viscoelasticity measured by stress/strain controlled rheometer (Anton Paar, MCR 301/MCR 501).

Secondary Outcome Measures

Name	Time	Method
Change in shear viscosity (η)	Baseline - immediately post exercise - 45min post exercise	Shear viscosity measured by stress/strain controlled rheometer (Anton Paar, MCR 301/MCR 501).
Change in sputum spinnability (mm)	Baseline - immediately post exercise - 45min post exercise	Measured with a Capillary Breakup Extensional Rheometer (CaBER).
Change in sputum solids content (%)	Baseline - immediately post exercise - 45min post exercise	Sputum weight of a 50 μL aliquot before and after lyophilization to dryness using a freeze dryer.
Change in lung diffusion capacity for nitric oxide (DLNO)	Baseline - immediately post exercise - 45min post exercise	Single-breath measurements with MasterScreenTM PFT system
Change in lung diffusion capacity for carbon monoxide (DLCO)	Baseline - immediately post exercise - 45min post exercise	Single-breath measurements with MasterScreenTM PFT system
Change in DLNO/DLCO ratio	Baseline - immediately post exercise - 45min post exercise	Single-breath measurements with MasterScreenTM PFT system
Change in alveolar volume	Baseline - immediately post exercise - 45min post exercise	Single-breath measurements with MasterScreenTM PFT system
Change in pulmonary capillary blood volume	Baseline - immediately post exercise - 45min post exercise	Single-breath measurements with MasterScreenTM PFT system
Change in pulmonary membrane diffusion capacity	Baseline - immediately post exercise - 45min post exercise	Single-breath measurements with MasterScreenTM PFT system
Change in ease of sputum expectoration (cm)	Baseline - immediately post exercise - 45min post exercise	Assessed by a visual analogue scale (0-10)
Change in oxygen saturation (%)	Baseline - immediately post exercise - 45min post exercise	Measured by pulse oximetry.

Trial Locations

Locations (3)

University of Zurich; 🇨🇭 Zurich, Switzerland

ETH Zurich; 🇨🇭 Zurich, Switzerland

University Hospital Zurich; 🇨🇭 Zurich, Switzerland