Standardization of 6 Minute Walk Test
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Assessment of Exercise Capacity and Standardization of Six Minute Walk Test in Patients With Pulmonary Hypertension|
- change of six minute walk distance between baseline measurement and measurement with more effort or less effort [ Time Frame: the six minute walk test with a different effort is performed 1 hour after the baseline test. The second baseline test and the missing test with a different effort takes place within three months. ] [ Designated as safety issue: No ]distance at six minute walk performed by different efforts
|Study Start Date:||July 2011|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
patients with pulmonary hypertension and with exercise-induced pulmonary hypertension take part
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399983
|Medical University of Graz|
|Graz, Austria, 8036|
|Principal Investigator:||Horst Olschewski, MD||Medical University of Graz|