Cystic FibrosisNCT02750722
Exercise and Oscillatory Positive Expiratory Pressure Therapy in Cystic Fibrosis
A study testing Flutter® and No Flutter® in people with Cystic Fibrosis, run by University of Zurich at 3 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Flutter® and No Flutter®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesSwitzerland
- Study dates
- May 2016to 19 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
University of Zurich
Zurich, Canton of Zurich, 8001
University Hospital Zurich
Zurich, Canton of Zurich, 8091
ETH Zurich
Zurich, Canton of Zurich, 8092
About this study
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
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Flutter®, No Flutter®
- Keywords
- Exercise, Lung diffusion capacity, Sputum viscoelasticity, Lung disease
- Medical subject headings
- Cystic Fibrosis, Motor Activity, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flutter®Device
Acute exercise with Flutter® breathing therapy.
No Flutter®Device
Acute exercise without Flutter® breathing therapy.
| Study group | Role | What they receive |
|---|---|---|
| Cycling in combination with Flutter® therapy | Experimental | 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®. Receives: Device: Flutter® |
| Cycling without Flutter® therapy | Active comparator | Participants perform 30 minutes of continuous moderately intense cycling exercise at 75% of their maximal heart rate without additional Flutter® breathing maneuvers. Receives: Device: No Flutter® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline - immediately post exercise - 45min post exercise
Secondary outcomes (11)
Change in shear viscosity (η)
Shear viscosity measured by stress/strain controlled rheometer (Anton Paar, MCR 301/MCR 501).
Measured: Baseline - immediately post exercise - 45min post exercise
Change in sputum spinnability (mm)
Measured with a Capillary Breakup Extensional Rheometer (CaBER).
Measured: Baseline - immediately post exercise - 45min post exercise
Change in sputum solids content (%)
Sputum weight of a 50 μL aliquot before and after lyophilization to dryness using a freeze dryer.
Measured: Baseline - immediately post exercise - 45min post exercise
Change in lung diffusion capacity for nitric oxide (DLNO)
Single-breath measurements with MasterScreenTM PFT system
Measured: Baseline - immediately post exercise - 45min post exercise
Change in lung diffusion capacity for carbon monoxide (DLCO)
Single-breath measurements with MasterScreenTM PFT system
Measured: Baseline - immediately post exercise - 45min post exercise
Change in DLNO/DLCO ratio
Single-breath measurements with MasterScreenTM PFT system
Measured: Baseline - immediately post exercise - 45min post exercise
Change in alveolar volume
Single-breath measurements with MasterScreenTM PFT system
Measured: Baseline - immediately post exercise - 45min post exercise
Change in pulmonary capillary blood volume
Single-breath measurements with MasterScreenTM PFT system
Measured: Baseline - immediately post exercise - 45min post exercise
Change in pulmonary membrane diffusion capacity
Single-breath measurements with MasterScreenTM PFT system
Measured: Baseline - immediately post exercise - 45min post exercise
Change in ease of sputum expectoration (cm)
Assessed by a visual analogue scale (0-10)
Measured: Baseline - immediately post exercise - 45min post exercise
Change in oxygen saturation (%)
Measured by pulse oximetry.
Measured: Baseline - immediately post exercise - 45min post exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startMay 2016
- Primary completion19 Jan 2017
- Study completion19 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Radtke, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750722
- Sponsor's protocol ID
- 2015-00153
- Other IDs
- 2015
- Status last verified
- Jan 2017
- First submitted
- 12 Apr 2016
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29898704
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02750722
- Acronym / sponsor ID
- 2015-00153
- Conditions
- Cystic Fibrosis
- Keywords
- Exercise, Lung diffusion capacity, Sputum viscoelasticity, Lung disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 19 Jan 2017 (actual)
- Study completion
- 19 Jan 2017 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycling in combination with Flutter® therapy | Experimental | Device: 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®. |
| Cycling without Flutter® therapy | Active comparator | Device: No Flutter®Participants perform 30 minutes of continuous moderately intense cycling exercise at 75% of their maximal heart rate without additional Flutter® breathing maneuvers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flutter®Acute exercise with Flutter® breathing therapy. | Device | Cycling in combination with Flutter® therapy |
| No Flutter®Acute exercise without Flutter® breathing therapy. | Device | Cycling without Flutter® therapy |
Primary outcome
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).
11 secondary outcomes
Change in shear viscosity (η)
Time frame: Baseline - immediately post exercise - 45min post exercise
Change in sputum spinnability (mm)
Time frame: Baseline - immediately post exercise - 45min post exercise
Change in sputum solids content (%)
Time frame: Baseline - immediately post exercise - 45min post exercise
Change in lung diffusion capacity for nitric oxide (DLNO)
Time frame: Baseline - immediately post exercise - 45min post exercise
Change in lung diffusion capacity for carbon monoxide (DLCO)
Time frame: Baseline - immediately post exercise - 45min post exercise
Change in DLNO/DLCO ratio
Time frame: Baseline - immediately post exercise - 45min post exercise
Change in alveolar volume
Time frame: Baseline - immediately post exercise - 45min post exercise
Change in pulmonary capillary blood volume
Time frame: Baseline - immediately post exercise - 45min post exercise
Change in pulmonary membrane diffusion capacity
Time frame: Baseline - immediately post exercise - 45min post exercise
Change in ease of sputum expectoration (cm)
Time frame: Baseline - immediately post exercise - 45min post exercise
Change in oxygen saturation (%)
Time frame: Baseline - immediately post exercise - 45min post exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Derived from this study: PubMed 29898704Radtke 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Radtke, PhD principal investigator
University of Zurich
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flutter® and No Flutter® in people with Cystic Fibrosis, run by University of Zurich at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sputum viscoelasticity (G*) over a broad frequency range (1-100 rad.s-1) (time frame: Baseline - immediately post exercise - 45min post exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02750722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017.