Study of Individualized Physiotherapy for Airway Clearance in Cystic Fibrosis.

Cystic Fibrosis Clinical Trial

Official title:

Efficacy Study of Physiotherapy for Airway Clearance in Cystic Fibrosis. Randomized Controlled Trials in Single Subjects (N of 1 RCT`s).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01266473
• Other study ID #: 2010/802
• Status: Completed
• Phase: N/A
• First received: September 6, 2010
• Last updated: January 10, 2013
• Start date: August 2010
• Est. completion date: April 2011

Study information

• Verified date: January 2013
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Physiotherapy
Physiotherapy for Airway Clearance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physiological measurements	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.	8 weeks	Yes
Other	Health related quality of life (HRQOL)	HRQOL measured by the Cystic Fibrosis Questionnaire Revised (CFQR-R), i.e. respiratory symptoms, in the beginning and at completion of the study.	8 weeks	No
Primary	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	No
Secondary	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.	8 weeks	No