Clinical Trials Directory

Trials / Completed

CompletedNCT01399983

Standardization of 6 Minute Walk Test

Assessment of Exercise Capacity and Standardization of Six Minute Walk Test in Patients With Pulmonary Hypertension

Status
Completed
Phase
Study type
Observational
Enrollment
29 (actual)
Sponsor
Medical University of Graz · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

Summary

The 6 minute walk (6MW) gives information about the exercise capacity and it is an important tool for clinical decisions and for the prognostic evaluation of PH patients. The test is technically simple to perform, inexpensive and reproducible. During the 6MW O2 saturation, heart rate, walking distance (in this study after every minute) and the level of dyspnea (BORG-dyspnea scale) may be recorded; however, at present, mainly the walking distance is evaluated. The test is sometimes criticized, because of the dependence on the patient's motivation. The purpose of the present study is to standardize the test by the incorporation of objective factors. The investigators are correlating the change of heart rate and dyspnea (BORG scale) with the achieved walking distance during subsequent examinations performed with different effort.

Detailed description

On two different days the patients have to absolve four 6MW on different levels of effort - on both days a traditional test will be performed and additionally a test with more effort or with less effort. The order of the tests will be randomized. These two days of the examinations should be within a maximum of three months, provided that there is no sign of relevant clinical changes. After every minute the walking distance is determined. Heart rate and the O2 saturation are measured by pulsoxymetry during the whole test. Every two minutes the patients are asked about their dyspnea (Borg scale). The purpose of the present study is to standardize the test by the incorporation of objective factors and to detect the correlation between the walking distance and the level of effort during exercise. The investigators expect that the reliability and objectivity of 6MW may increase by the standardization. The additionally performed cardiopulmonary exercise testing helps to evaluate and stratify patients.

Conditions

Timeline

Start date
2011-07-01
Primary completion
2011-10-01
Completion
2011-10-01
First posted
2011-07-22
Last updated
2012-03-09

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT01399983. Inclusion in this directory is not an endorsement.