search
Back to results

Exercise and Oscillatory Positive Expiratory Pressure Therapy in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Flutter®
No Flutter®
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Exercise, Lung diffusion capacity, Sputum viscoelasticity, Lung disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Zurich
  • University Hospital Zurich
  • ETH Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cycling in combination with Flutter® therapy

Cycling without Flutter® therapy

Arm Description

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®.

Participants perform 30 minutes of continuous moderately intense cycling exercise at 75% of their maximal heart rate without additional Flutter® breathing maneuvers.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in shear viscosity (η)
Shear viscosity measured by stress/strain controlled rheometer (Anton Paar, MCR 301/MCR 501).
Change in sputum spinnability (mm)
Measured with a Capillary Breakup Extensional Rheometer (CaBER).
Change in sputum solids content (%)
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)
Single-breath measurements with MasterScreenTM PFT system
Change in lung diffusion capacity for carbon monoxide (DLCO)
Single-breath measurements with MasterScreenTM PFT system
Change in DLNO/DLCO ratio
Single-breath measurements with MasterScreenTM PFT system
Change in alveolar volume
Single-breath measurements with MasterScreenTM PFT system
Change in pulmonary capillary blood volume
Single-breath measurements with MasterScreenTM PFT system
Change in pulmonary membrane diffusion capacity
Single-breath measurements with MasterScreenTM PFT system
Change in ease of sputum expectoration (cm)
Assessed by a visual analogue scale (0-10)
Change in oxygen saturation (%)
Measured by pulse oximetry.

Full Information

First Posted
April 12, 2016
Last Updated
January 24, 2017
Sponsor
University of Zurich
search

1. Study Identification

Unique Protocol Identification Number
NCT02750722
Brief Title
Exercise and Oscillatory Positive Expiratory Pressure Therapy in Cystic Fibrosis
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
January 19, 2017 (Actual)
Study Completion Date
January 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Exercise, Lung diffusion capacity, Sputum viscoelasticity, Lung disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cycling in combination with Flutter® therapy
Arm Type
Experimental
Arm Description
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®.
Arm Title
Cycling without Flutter® therapy
Arm Type
Active Comparator
Arm Description
Participants perform 30 minutes of continuous moderately intense cycling exercise at 75% of their maximal heart rate without additional Flutter® breathing maneuvers.
Intervention Type
Device
Intervention Name(s)
Flutter®
Intervention Description
Acute exercise with Flutter® breathing therapy.
Intervention Type
Device
Intervention Name(s)
No Flutter®
Intervention Description
Acute exercise without Flutter® breathing therapy.
Primary Outcome Measure Information:
Title
Change in sputum viscoelasticity (G*) over a broad frequency range (1-100 rad.s-1)
Description
Sputum viscoelasticity measured by stress/strain controlled rheometer (Anton Paar, MCR 301/MCR 501).
Time Frame
Baseline - immediately post exercise - 45min post exercise
Secondary Outcome Measure Information:
Title
Change in shear viscosity (η)
Description
Shear viscosity measured by stress/strain controlled rheometer (Anton Paar, MCR 301/MCR 501).
Time Frame
Baseline - immediately post exercise - 45min post exercise
Title
Change in sputum spinnability (mm)
Description
Measured with a Capillary Breakup Extensional Rheometer (CaBER).
Time Frame
Baseline - immediately post exercise - 45min post exercise
Title
Change in sputum solids content (%)
Description
Sputum weight of a 50 μL aliquot before and after lyophilization to dryness using a freeze dryer.
Time Frame
Baseline - immediately post exercise - 45min post exercise
Title
Change in lung diffusion capacity for nitric oxide (DLNO)
Description
Single-breath measurements with MasterScreenTM PFT system
Time Frame
Baseline - immediately post exercise - 45min post exercise
Title
Change in lung diffusion capacity for carbon monoxide (DLCO)
Description
Single-breath measurements with MasterScreenTM PFT system
Time Frame
Baseline - immediately post exercise - 45min post exercise
Title
Change in DLNO/DLCO ratio
Description
Single-breath measurements with MasterScreenTM PFT system
Time Frame
Baseline - immediately post exercise - 45min post exercise
Title
Change in alveolar volume
Description
Single-breath measurements with MasterScreenTM PFT system
Time Frame
Baseline - immediately post exercise - 45min post exercise
Title
Change in pulmonary capillary blood volume
Description
Single-breath measurements with MasterScreenTM PFT system
Time Frame
Baseline - immediately post exercise - 45min post exercise
Title
Change in pulmonary membrane diffusion capacity
Description
Single-breath measurements with MasterScreenTM PFT system
Time Frame
Baseline - immediately post exercise - 45min post exercise
Title
Change in ease of sputum expectoration (cm)
Description
Assessed by a visual analogue scale (0-10)
Time Frame
Baseline - immediately post exercise - 45min post exercise
Title
Change in oxygen saturation (%)
Description
Measured by pulse oximetry.
Time Frame
Baseline - immediately post exercise - 45min post exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Radtke, PhD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Zurich
City
Zurich
ZIP/Postal Code
8001
Country
Switzerland
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
ETH Zurich
City
Zurich
ZIP/Postal Code
8092
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29898704
Citation
Radtke T, Boni L, Bohnacker P, Maggi-Beba M, Fischer P, Kriemler S, Benden C, Dressel H. Acute effects of combined exercise and oscillatory positive expiratory pressure therapy on sputum properties and lung diffusing capacity in cystic fibrosis: a randomized, controlled, crossover trial. BMC Pulm Med. 2018 Jun 14;18(1):99. doi: 10.1186/s12890-018-0661-1.
Results Reference
derived

Learn more about this trial

Exercise and Oscillatory Positive Expiratory Pressure Therapy in Cystic Fibrosis

We'll reach out to this number within 24 hrs