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Study of Individualized Physiotherapy for Airway Clearance in Cystic Fibrosis.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01266473
First Posted: December 24, 2010
Last Update Posted: January 11, 2013
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.
Information provided by (Responsible Party):
Oslo University Hospital
  Purpose
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 Intervention
Cystic Fibrosis Other: Physiotherapy

Study Type: Interventional
Study Design: 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).

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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:
  • 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:
  • 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.


  • 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.


Enrollment: 6
Study Start Date: August 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physiotherapy techniques
Cough Technique vs Forced Expiration Technique
Other: Physiotherapy
Physiotherapy for Airway Clearance

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Investigators
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 Submitted: September 6, 2010
First Posted: December 24, 2010
Last Update Posted: January 11, 2013
Last Verified: January 2013

Keywords provided by Oslo University Hospital:
Adults

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