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Exercise and Oscillatory Positive Expiratory Pressure Therapy in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT02750722
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Device: Flutter® Device: No Flutter® Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : May 2016
Actual Primary Completion Date : January 19, 2017
Actual Study Completion Date : January 19, 2017


Arm Intervention/treatment
Experimental: Cycling in combination with Flutter® therapy
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®.
Device: Flutter®
Acute exercise with Flutter® breathing therapy.

Active Comparator: Cycling without Flutter® therapy
Participants perform 30 minutes of continuous moderately intense cycling exercise at 75% of their maximal heart rate without additional Flutter® breathing maneuvers.
Device: No Flutter®
Acute exercise without Flutter® breathing therapy.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750722


Locations
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Switzerland
University of Zurich
Zurich, Switzerland, 8001
University Hospital Zurich
Zurich, Switzerland, 8091
ETH Zurich
Zurich, Switzerland, 8092
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Thomas Radtke, PhD University of Zurich

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02750722     History of Changes
Other Study ID Numbers: 2015-00153
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Zurich:
Exercise
Lung diffusion capacity
Sputum viscoelasticity
Lung disease

Additional relevant MeSH terms:
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Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases