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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Zurich
- Enrollment
- 16
- Locations
- 6
- Primary Endpoint
- Change in sputum viscoelasticity (G*) over a broad frequency range (1-100 rad.s-1)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Change in shear viscosity (η)(Baseline - immediately post exercise - 45min post exercise)
- Change in sputum spinnability (mm)(Baseline - immediately post exercise - 45min post exercise)
- Change in sputum solids content (%)(Baseline - immediately post exercise - 45min post exercise)
- Change in lung diffusion capacity for nitric oxide (DLNO)(Baseline - immediately post exercise - 45min post exercise)
- Change in lung diffusion capacity for carbon monoxide (DLCO)(Baseline - immediately post exercise - 45min post exercise)
- Change in DLNO/DLCO ratio(Baseline - immediately post exercise - 45min post exercise)
- Change in alveolar volume(Baseline - immediately post exercise - 45min post exercise)
- Change in pulmonary capillary blood volume(Baseline - immediately post exercise - 45min post exercise)
- Change in pulmonary membrane diffusion capacity(Baseline - immediately post exercise - 45min post exercise)
- Change in ease of sputum expectoration (cm)(Baseline - immediately post exercise - 45min post exercise)
- Change in oxygen saturation (%)(Baseline - immediately post exercise - 45min post exercise)