Clinical Trials Directory

Trials / Completed

CompletedNCT00487149

Respiratory Muscle Strength in Bronchiectasis: Repeatability and Reliability

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
University of Ulster · Academic / Other
Sex
All
Age
40 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Timeline

Start date
2005-10-01
Completion
2008-07-01
First posted
2007-06-15
Last updated
2009-01-14

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT00487149. Inclusion in this directory is not an endorsement.