Standardization of 6 Minute Walk Test

NCT01399983 | Completed

• 1 other identifier: 23-069 ex 10/11
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

six minute walk

Outcome Measures

Primary Outcomes (1)

• change of six minute walk distance between baseline measurement and measurement with more effort or less effort

  distance at six minute walk performed by different efforts

  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.

Study Arms (1)

pulmonary hypertension

patients with pulmonary hypertension and with exercise-induced pulmonary hypertension take part

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Horst Olschewski, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: July 22, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

AU (1)