Exercise and Oscillatory Positive Expiratory Pressure Therapy in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Acute Effects of Combined Exercise and Oscillatory Positive Expiratory Pressure Therapy on Sputum Properties and Lung Diffusion Capacity in Cystic Fibrosis: a Randomized Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02750722
• Other study ID #: 2015-00153
• Status: Completed
• Phase: N/A
• First received: April 12, 2016
• Last updated: January 24, 2017
• Start date: May 2016
• Est. completion date: January 19, 2017

Study information

• Verified date: January 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 19, 2017
• Est. primary completion date: January 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• Flutter®
Acute exercise with Flutter® breathing therapy.
• No Flutter®
Acute exercise without Flutter® breathing therapy.

Locations

Country	Name	City	State
Switzerland	ETH Zurich	Zurich
Switzerland	University Hospital Zurich	Zurich
Switzerland	University of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sputum viscoelasticity (G*) over a broad frequency range (1-100 rad.s-1)	Sputum viscoelasticity measured by stress/strain controlled rheometer (Anton Paar, MCR 301/MCR 501).	Baseline - immediately post exercise - 45min post exercise
Secondary	Change in shear viscosity (?)	Shear viscosity measured by stress/strain controlled rheometer (Anton Paar, MCR 301/MCR 501).	Baseline - immediately post exercise - 45min post exercise
Secondary	Change in sputum spinnability (mm)	Measured with a Capillary Breakup Extensional Rheometer (CaBER).	Baseline - immediately post exercise - 45min post exercise
Secondary	Change in sputum solids content (%)	Sputum weight of a 50 µL aliquot before and after lyophilization to dryness using a freeze dryer.	Baseline - immediately post exercise - 45min post exercise
Secondary	Change in lung diffusion capacity for nitric oxide (DLNO)	Single-breath measurements with MasterScreenTM PFT system	Baseline - immediately post exercise - 45min post exercise
Secondary	Change in lung diffusion capacity for carbon monoxide (DLCO)	Single-breath measurements with MasterScreenTM PFT system	Baseline - immediately post exercise - 45min post exercise
Secondary	Change in DLNO/DLCO ratio	Single-breath measurements with MasterScreenTM PFT system	Baseline - immediately post exercise - 45min post exercise
Secondary	Change in alveolar volume	Single-breath measurements with MasterScreenTM PFT system	Baseline - immediately post exercise - 45min post exercise
Secondary	Change in pulmonary capillary blood volume	Single-breath measurements with MasterScreenTM PFT system	Baseline - immediately post exercise - 45min post exercise
Secondary	Change in pulmonary membrane diffusion capacity	Single-breath measurements with MasterScreenTM PFT system	Baseline - immediately post exercise - 45min post exercise
Secondary	Change in ease of sputum expectoration (cm)	Assessed by a visual analogue scale (0-10)	Baseline - immediately post exercise - 45min post exercise
Secondary	Change in oxygen saturation (%)	Measured by pulse oximetry.	Baseline - immediately post exercise - 45min post exercise