Skip to main content
OpenTrials
Completed

NCT Number: NCT02750722

Exercise and Oscillatory Positive Expiratory Pressure Therapy in Cystic Fibrosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ETH Zurich, Zurich, Canton of Zurich, Switzerland

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flutter®

Device

Acute exercise with Flutter® breathing therapy.

No Flutter®

Device

Acute exercise without Flutter® breathing therapy.

Primary outcomes

  1. Change in sputum viscoelasticity (G*) over a broad frequency range (1-100 rad.s-1)

    Time frame: Baseline - immediately post exercise - 45min post exercise

    Sputum viscoelasticity measured by stress/strain controlled rheometer (Anton Paar, MCR 301/MCR 501).

Secondary outcomes

  1. Change in shear viscosity (η)

    Time frame: Baseline - immediately post exercise - 45min post exercise

    Shear viscosity measured by stress/strain controlled rheometer (Anton Paar, MCR 301/MCR 501).

  2. Change in sputum spinnability (mm)

    Time frame: Baseline - immediately post exercise - 45min post exercise

    Measured with a Capillary Breakup Extensional Rheometer (CaBER).

  3. Change in sputum solids content (%)

    Time frame: Baseline - immediately post exercise - 45min post exercise

    Sputum weight of a 50 μL aliquot before and after lyophilization to dryness using a freeze dryer.

  4. Change in lung diffusion capacity for nitric oxide (DLNO)

    Time frame: Baseline - immediately post exercise - 45min post exercise

    Single-breath measurements with MasterScreenTM PFT system

  5. Change in lung diffusion capacity for carbon monoxide (DLCO)

    Time frame: Baseline - immediately post exercise - 45min post exercise

    Single-breath measurements with MasterScreenTM PFT system

  6. Change in DLNO/DLCO ratio

    Time frame: Baseline - immediately post exercise - 45min post exercise

    Single-breath measurements with MasterScreenTM PFT system

  7. Change in alveolar volume

    Time frame: Baseline - immediately post exercise - 45min post exercise

    Single-breath measurements with MasterScreenTM PFT system

  8. Change in pulmonary capillary blood volume

    Time frame: Baseline - immediately post exercise - 45min post exercise

    Single-breath measurements with MasterScreenTM PFT system

  9. Change in pulmonary membrane diffusion capacity

    Time frame: Baseline - immediately post exercise - 45min post exercise

    Single-breath measurements with MasterScreenTM PFT system

  10. Change in ease of sputum expectoration (cm)

    Time frame: Baseline - immediately post exercise - 45min post exercise

    Assessed by a visual analogue scale (0-10)

  11. Change in oxygen saturation (%)

    Time frame: Baseline - immediately post exercise - 45min post exercise

    Measured by pulse oximetry.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2016
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.