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Standardization of 6 Minute Walk Test

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: NCT01399983
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : March 9, 2012
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Tracking Information
First Submitted Date July 12, 2011
First Posted Date July 22, 2011
Last Update Posted Date March 9, 2012
Study Start Date July 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 20, 2011)
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. ]
distance at six minute walk performed by different efforts
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Standardization of 6 Minute Walk Test
Official Title Assessment of Exercise Capacity and Standardization of Six Minute Walk Test in Patients With Pulmonary Hypertension
Brief 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with pulmonary hypertension or exercise-induced pulmonary hypertension assessed by right heart catheterisation
Condition Pulmonary Hypertension
Intervention Not Provided
Study Groups/Cohorts pulmonary hypertension
patients with pulmonary hypertension and with exercise-induced pulmonary hypertension take part
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 8, 2012)
29
Original Estimated Enrollment
 (submitted: July 20, 2011)
20
Actual Study Completion Date October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • diagnosis of pulmonary hypertension or exercise-induced pulmonary hypertension by right heart catheterisation
  • informed consent

Exclusion Criteria:

  • Myocardiac Infarct within the last 12 months
  • Uncontrolled ventricular arrhythmia
  • Uncontrolled bradycardic or tachycardic supraventricular arrhythmia
  • relevant operations within the last 12 weeks
  • change of the hemodynamic therapy within the last 6 weeks
  • joint diseases or diseases of peripheral vessels and nerves which may make the results of the six minute walk test unreliable
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT01399983
Other Study ID Numbers 23-069 ex 10/11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medical University of Graz
Study Sponsor Medical University of Graz
Collaborators Not Provided
Investigators
Principal Investigator: Horst Olschewski, MD Medical University of Graz
PRS Account Medical University of Graz
Verification Date March 2012