Respiratory Muscle Strength in Bronchiectasis: Repeatability and Reliability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00487149
Recruitment Status : Completed
First Posted : June 15, 2007
Last Update Posted : January 14, 2009
Information provided by:
University of Ulster

Brief Summary:
Respiratory muscle strength is used as an outcome measure in intervention studies. There are reference values for respiratory muscle strength in 'healthy' people but not in those with bronchiectasis disease. The aim of this study is to investigate the reliability of respiratory muscle strength measurements and identify reference values for those with stable moderate to severe bronchiectasis disease.

Condition or disease
Healthy Bronchiectasis

Detailed Description:

Twenty 'healthy' participants and 20 participants with moderate to severe bronchiectasis in a stable state were recruited. Three readings for pulmonary function (FEV1); and respiratory muscle strength (PImax;PEmax) were taken on two occasions 10-14 days apart according to a standardised protocol.

A standard protocol and instructions for all measurements of respiratory strength were used. Measurements were made at the same time of day and with no change in medication. Before the subject undertook the respiratory muscle strength tests the assessor provided verbal explanations and demonstration of the procedure. The subject then had a practice run before values were recorded. Values were reported as positive numbers.

Measurements were obtained by one of three assessors. Pretraining ensured that all assessors followed standardised methodology.

Pulmonary function measures were conducted according to the ATS standards (ATS, 2002). The FEV1 percentage predicted value was reported as the ECCS scale. FEV1 had to remain within 10% to eliminate the possibility of a pulmonary exacerbation.

Respiratory muscle strength measurements were conducted using a handheld mouth pressure meter, a one way inspiratory or expiratory valve, a single use bacterial filter, nose clips and a standard flanged mouthpiece (Micro Medical Ltd UK). The pressure gauge was calibrated with a small air leak (greater than 1mm in diameter) to reduce use of the buccal muscles. A hand held mouth pressure machine computed average pressures in cmH2O sustained over two seconds and a microprocessor displayed a digital result.PImax was measured near residual volume after maximal expiration. PEmax was measured near total lung capacity after a maximal inspiration. There was a minute's rest between each manoeuvre. Verbal encouragement was given to each participant to obtain maximal effort. Three technically acceptable readings for inspiratory and expiratory pressure measured were recorded.

All participants gave written informed consent.

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : October 2005
Actual Study Completion Date : July 2008

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • All participants:over 40 years of age,non smokers,able to perform lung function tests and available for a repeat measure 10-14 days later.
  • Specific inclusion criteria for healthy participants:no known respiratory or cardiac condition and no prescription antibiotics for a chest complaint.
  • Specific inclusion criteria for bronchiectasis group:

    • Diagnosis of bronchiectasis by CT scan;
    • Moderate to severe disease (FEV1 < 60% predicted);
    • In a stable state i.e. no administration of oral or intravenous antibiotics in preceding 3 weeks;
    • No change in medication such as bronchodilators, oxygen, long term prophylactic antibiotics or steroids in the 3 weeks preceding the study.

Exclusion Criteria:

  • Any co-morbid condition that could influence muscle strength or if participants live greater than 50 miles from the hospital.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00487149

United Kingdom
Belfast City Hospital
Belfast, Northern Ireland, United Kingdom, BT9 7AB
Sponsors and Collaborators
University of Ulster
Principal Investigator: Fidelma Moran, BSc(Hons) University of Ulster

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00487149     History of Changes
Other Study ID Numbers: 1233R0203
First Posted: June 15, 2007    Key Record Dates
Last Update Posted: January 14, 2009
Last Verified: January 2009

Keywords provided by University of Ulster:
Respiratory Muscle Strength

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases