Study of Individualized Physiotherapy for Airway Clearance in Cystic Fibrosis.
|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).|
- 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.
- 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.
- 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.
|Study Start Date:||August 2010|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: Physiotherapy techniques
Cough Technique vs Forced Expiration Technique
Physiotherapy for Airway Clearance
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266473
|Principal Investigator:||Sandra Gursli, PT, MSc||Oslo University Hospital, National Centre for cystic fibrosis|