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Study of Individualized Physiotherapy for Airway Clearance in Cystic Fibrosis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01266473
Recruitment Status : Completed
First Posted : December 24, 2010
Last Update Posted : January 11, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to investigate individual efficacy in Physiotherapy for Airway Clearance, and to investigate user experience, i.e.utility value and preference.

Condition or disease Intervention/treatment
Cystic Fibrosis Other: Physiotherapy

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy Study of Physiotherapy for Airway Clearance in Cystic Fibrosis. Randomized Controlled Trials in Single Subjects (N of 1 RCT`s).
Study Start Date : August 2010
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Physiotherapy techniques
Cough Technique vs Forced Expiration Technique
Other: Physiotherapy
Physiotherapy for Airway Clearance

Outcome Measures

Primary Outcome Measures :
  1. Expectorated sputum (gram) [ Time Frame: 8 weeks ]

    Total amount of expectorated sputum (g) will be collected and weighed wet after each intervention for eight weeks, using a Mettler TOLEDO Weighing Balance (EL 202, accuracy: 0.01 g).

    N of 1 trial design. Each trial consist of eight pairs (8 weeks) of treatment periods with two interventions each week (one with Cough Technique and one with Forced Expiration technique), 16 treatments for each participant. Outcome measure after each treatment.

Secondary Outcome Measures :
  1. Patient's experience, i.e. perceived utility value and preference of technique. [ Time Frame: 8 weeks ]

    Utility value: Measured by self-reported questionnaire after completion of each intervention in week 8.

    Preference: Measured by three self-reported questions after both interventions in week 8.

Other Outcome Measures:
  1. Physiological measurements [ Time Frame: 8 weeks ]

    Oxygen saturation and heart rate measurements in the beginning and at the end of each intervention.

    Pulmonary function tests (week 2): measurements before and after each intervention with spirometry.

  2. Health related quality of life (HRQOL) [ Time Frame: 8 weeks ]
    HRQOL measured by the Cystic Fibrosis Questionnaire Revised (CFQR-R), i.e. respiratory symptoms, in the beginning and at completion of the study.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis: CF
  • Age >18 years
  • Amount of sputum >5 ml/60 min
  • Wet inhalation of saline/DNase/both
  • Informed consent

Exclusion Criteria:

  • Respiratory failure
  • Hemoptysis
  • Bacteriology (burkholderia cephacia, multi-resistent pseudomonas aeruginosa, atypical mycobacteria, MRSA).
  • Ongoing intravenous medication
  • Pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266473

Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Sandra Gursli, PT, MSc Oslo University Hospital, National Centre for cystic fibrosis
More Information

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01266473     History of Changes
Other Study ID Numbers: 2010/802
First Posted: December 24, 2010    Key Record Dates
Last Update Posted: January 11, 2013
Last Verified: January 2013

Keywords provided by Oslo University Hospital:

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases