Comparison of the Two and Six- Minute Walk Tests in Evaluating Oxygen Desaturation in Patients With Severe COPD

June 3, 2015 updated by: Klaus Kenn, Schön Klinik Berchtesgadener Land

All measurements are performed on two consecutive days at the beginning of a pulmonary rehabilitation program in a randomized cross-over study design. On the first day, each patient is randomly assigned to perform either the 2 minute walk test or the 6 Minute walk test. On the second day each patient performs the test that was not performed on the first day. All walk tests are performed by the same investigator on the same track and time of day, following the 2002 guidelines of the American Thoracic Society.

Patients wear a mobile pulse oximeter that continuously records heart rate and oxygen saturation during testing. Baseline values of oxygen saturation, heart rate and ratings of perceived exertion on the modified Borg scale (0 to 10) for dyspnea and leg fatigue are recorded at rest after 10 minutes of sitting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • confirmed diagnosis of chronic obstructive lung disease stage III or IV according to the Global Initiative for chronic Obstructive Lung Diseases definition
  • ability to read and understand the German language and study procedures.
  • written informed consent

Exclusion Criteria:

  • severe acute exacerbation of chronic obstructive lung disease
  • severe respiratory failure (partial Oxygen pressure at rest lower than 55 millimeter mercury)
  • non compliance to the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 2 minute walk test
Other: walk tests
Other: 6 minute walk test
Other: walk tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
oxygen desaturation
Time Frame: up to 6 minute walk test
up to 6 minute walk test

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate
Time Frame: during 2 minute walk test and 6 minute walk test
during 2 minute walk test and 6 minute walk test
perceived exertion for dyspnea and leg fatigue
Time Frame: during 2 minute walk test and 6 minute walk test
measured by a modified Borg scale from 0 to 10
during 2 minute walk test and 6 minute walk test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schön Klinik Berchtesgadener Land

Investigators

  • Principal Investigator: Klaus Kenn, MD, Schoen Klinik Berchtesgadener Land

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

June 2, 2015

First Submitted That Met QC Criteria

June 3, 2015

First Posted (Estimate)

June 4, 2015

Study Record Updates

Last Update Posted (Estimate)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • walk test trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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