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).

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01266473

Enrollment

Registered

2010-12-24

Start date

2010-08-31

Completion date

2011-04-30

Last updated

2013-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Adults

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.

Interventions

OTHERPhysiotherapy

Physiotherapy for Airway Clearance

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Expectorated sputum (gram)	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.

Secondary

Measure	Time frame	Description
Patient's experience, i.e. perceived utility value and preference of technique.	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.

Other

Measure	Time frame	Description
Physiological measurements	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)	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026