Clinical trial NCT02750722: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Exercise
Lung diffusion capacity
Sputum viscoelasticity
Lung disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in sputum viscoelasticity (G*) over a broad frequency range (1-100 rad.s-1)
timeFrame: Baseline - immediately post exercise - 45min post exercise
Secondary outcomes:
measure: Change in shear viscosity (η)
timeFrame: Baseline - immediately post exercise - 45min post exercise
measure: Change in sputum spinnability (mm)
timeFrame: Baseline - immediately post exercise - 45min post exercise
measure: Change in sputum solids content (%)
timeFrame: Baseline - immediately post exercise - 45min post exercise
measure: Change in lung diffusion capacity for nitric oxide (DLNO)
timeFrame: Baseline - immediately post exercise - 45min post exercise
measure: Change in lung diffusion capacity for carbon monoxide (DLCO)
timeFrame: Baseline - immediately post exercise - 45min post exercise
measure: Change in DLNO/DLCO ratio
timeFrame: Baseline - immediately post exercise - 45min post exercise
measure: Change in alveolar volume
timeFrame: Baseline - immediately post exercise - 45min post exercise
measure: Change in pulmonary capillary blood volume
timeFrame: Baseline - immediately post exercise - 45min post exercise
measure: Change in pulmonary membrane diffusion capacity
timeFrame: Baseline - immediately post exercise - 45min post exercise
measure: Change in ease of sputum expectoration (cm)
timeFrame: Baseline - immediately post exercise - 45min post exercise
measure: Change in oxygen saturation (%)
timeFrame: Baseline - immediately post exercise - 45min post exercise
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich
city: Zurich
country: Switzerland
facility: University Hospital Zurich
city: Zurich
country: Switzerland
facility: ETH Zurich
Study officials:
affiliation: University of Zurich
name: Thomas Radtke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.