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.|
|ClinicalTrials.gov Identifier: NCT00487149|
Recruitment Status : Completed
First Posted : June 15, 2007
Last Update Posted : January 14, 2009
|First Submitted Date||June 13, 2007|
|First Posted Date||June 15, 2007|
|Last Update Posted Date||January 14, 2009|
|Study Start Date||October 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00487149 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Respiratory Muscle Strength in Bronchiectasis: Repeatability and Reliability|
|Official Title||Not Provided|
|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.|
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 Design||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
|Publications *||Moran F, Piper A, Elborn JS, Bradley JM. Respiratory muscle pressures in non-CF bronchiectasis: repeatability and reliability. Chron Respir Dis. 2010 Aug;7(3):165-71. doi: 10.1177/1479972310375595.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Actual Enrollment||Same as current|
|Actual Study Completion Date||July 2008|
|Primary Completion Date||Not Provided|
|Ages||40 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United Kingdom|
|Removed Location Countries|
|Other Study ID Numbers||1233R0203|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||University of Ulster|
|PRS Account||University of Ulster|
|Verification Date||January 2009|