Exercise and Oscillatory Positive Expiratory Pressure Therapy in Cystic Fibrosis

NCT ID: NCT02750722

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-01-19

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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®.

Group Type: EXPERIMENTAL

Flutter®

Intervention Type: DEVICE

Acute exercise with Flutter® breathing therapy.

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.

Group Type: ACTIVE_COMPARATOR

No Flutter®

Intervention Type: DEVICE

Acute exercise without Flutter® breathing therapy.

Interventions

Flutter®

Acute exercise with Flutter® breathing therapy.

Intervention Type: DEVICE

No Flutter®

Acute exercise without Flutter® breathing therapy.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Radtke, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

University of Zurich

Zurich, Canton of Zurich, Switzerland

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

ETH Zurich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 29898704 (View on PubMed)

Other Identifiers

2015-00153

Identifier Type: -

Identifier Source: org_study_id