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Standardization of 6 Minute Walk Test

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01399983
First received: July 12, 2011
Last updated: March 8, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition
Pulmonary Hypertension

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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


Enrollment: 29
Study Start Date: July 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
pulmonary hypertension
patients with pulmonary hypertension and with exercise-induced pulmonary hypertension take part

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with pulmonary hypertension or exercise-induced pulmonary hypertension assessed by right heart catheterisation

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399983

Locations
Austria
Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Horst Olschewski, MD Medical University of Graz
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01399983     History of Changes
Other Study ID Numbers: 23-069 ex 10/11
Study First Received: July 12, 2011
Last Updated: March 8, 2012
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Graz:
six minute walk

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013