Skip to main content
OpenTrials
Completed

NCT Number: NCT01399983

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz

Graz, 8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 22, 2011
Registry last updated
Mar 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.