Study of Individualized Physiotherapy for Airway Clearance in Cystic Fibrosis.
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|ClinicalTrials.gov Identifier: NCT01266473|
Recruitment Status : Completed
First Posted : December 24, 2010
Last Update Posted : January 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Other: Physiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Experimental: Physiotherapy techniques
Cough Technique vs Forced Expiration Technique
Physiotherapy for Airway Clearance
- 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.
- 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.
- 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.
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
|Principal Investigator:||Sandra Gursli, PT, MSc||Oslo University Hospital, National Centre for cystic fibrosis|