Exercise and Oscillatory Positive Expiratory Pressure Therapy in Cystic Fibrosis

NCT02750722 | Completed

• 1 other identifier: 2015-00153
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

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.

Conditions

Cystic Fibrosis

Keywords

Exercise; Lung diffusion capacity; Sputum viscoelasticity; Lung disease

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline - immediately post exercise - 45min post exercise

Secondary Outcomes (11)

• 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

Study Arms (2)

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®.

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.

Device: No Flutter®

Interventions

Flutter® DEVICE

Acute exercise with Flutter® breathing therapy.

Cycling in combination with Flutter® therapy

No Flutter® DEVICE

Acute exercise without Flutter® breathing therapy.

Cycling without Flutter® therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (3)

University of Zurich

Zurich, Canton of Zurich, 8001, Switzerland

Location

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

ETH Zurich

Zurich, Canton of Zurich, 8092, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 29898704 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity; Lung Diseases

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Study Officials

• Thomas Radtke, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 25, 2016
• Study Start: May 1, 2016
• Primary Completion: January 19, 2017
• Study Completion: January 19, 2017
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

CH (3)