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Completed

NCT Number: NCT01266473

Study of Individualized Physiotherapy for Airway Clearance in Cystic Fibrosis.

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapy

Other

Physiotherapy for Airway Clearance

Primary outcomes

  1. Expectorated sputum (gram)

    Time frame: 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 outcomes

  1. Patient's experience, i.e. perceived utility value and preference of technique.

    Time frame: 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 outcomes

  1. Physiological measurements

    Time frame: 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.

  2. Health related quality of life (HRQOL)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 24, 2010
Registry last updated
Jan 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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