Back to resultsStudy of Individualized Physiotherapy for Airway Clearance in Cystic Fibrosis.
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Adults
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Physiotherapy techniques
Arm Description
Cough Technique vs Forced Expiration Technique
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Patient's experience, i.e. perceived utility value and preference of technique.
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.
Full Information
NCT ID
NCT01266473
First Posted
September 6, 2010
Last Updated
January 10, 2013
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01266473
Brief Title
Study of Individualized Physiotherapy for Airway Clearance in Cystic Fibrosis.
Official Title
Efficacy Study of Physiotherapy for Airway Clearance in Cystic Fibrosis. Randomized Controlled Trials in Single Subjects (N of 1 RCT's).
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy techniques
Arm Type
Experimental
Arm Description
Cough Technique vs Forced Expiration Technique
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
Physiotherapy for Airway Clearance
Primary Outcome Measure Information:
Title
Expectorated sputum (gram)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Patient's experience, i.e. perceived utility value and preference of technique.
Description
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.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Physiological measurements
Description
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.
Time Frame
8 weeks
Title
Health related quality of life (HRQOL)
Description
HRQOL measured by the Cystic Fibrosis Questionnaire Revised (CFQR-R), i.e. respiratory symptoms, in the beginning and at completion of the study.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Gursli, PT, MSc
Organizational Affiliation
Oslo University Hospital, National Centre for cystic fibrosis
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
36256673
Citation
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.
Results Reference
derived
Learn more about this trial
Study of Individualized Physiotherapy for Airway Clearance in Cystic Fibrosis.
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