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Study of Individualized Physiotherapy for Airway Clearance in Cystic Fibrosis.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01266473
First received: September 6, 2010
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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:

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

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Expectorated sputum (gram) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266473

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

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01266473     History of Changes
Other Study ID Numbers: 2010/802
Study First Received: September 6, 2010
Last Updated: January 10, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Adults

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

ClinicalTrials.gov processed this record on May 16, 2013