Study of Individualized Physiotherapy for Airway Clearance in Cystic Fibrosis.
Efficacy Study of Physiotherapy for Airway Clearance in Cystic Fibrosis. Randomized Controlled Trials in Single Subjects (N of 1 RCT's).
1 other identifier
interventional
6
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2010
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 6, 2010
CompletedFirst Posted
Study publicly available on registry
December 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedJanuary 11, 2013
January 1, 2013
8 months
September 6, 2010
January 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Expectorated sputum (gram)
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.
8 weeks
Secondary Outcomes (1)
Patient's experience, i.e. perceived utility value and preference of technique.
8 weeks
Other Outcomes (2)
Physiological measurements
8 weeks
Health related quality of life (HRQOL)
8 weeks
Study Arms (1)
Physiotherapy techniques
EXPERIMENTALCough Technique vs Forced Expiration Technique
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis: CF
- Age \>18 years
- Amount of sputum \>5 ml/60 min
- Wet inhalation of saline/DNase/both
- Informed consent
You may not qualify if:
- Respiratory failure
- Hemoptysis
- Bacteriology (burkholderia cephacia, multi-resistent pseudomonas aeruginosa, atypical mycobacteria, MRSA).
- Ongoing intravenous medication
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Gursli S, Quittner A, Jahnsen RB, Skrede B, Stuge B, Bakkeheim E. Airway clearance physiotherapy and health-related quality of life in cystic fibrosis. PLoS One. 2022 Oct 18;17(10):e0276310. doi: 10.1371/journal.pone.0276310. eCollection 2022.
PMID: 36256673DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra Gursli, PT, MSc
Oslo University Hospital, National Centre for cystic fibrosis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2010
First Posted
December 24, 2010
Study Start
August 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
January 11, 2013
Record last verified: 2013-01