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

• Sponsor: Schön Klinik Berchtesgadener Land (Other)
• Overall Status: Completed
• CT.gov ID: NCT02462343
• Collaborator: (none)
• Enrollment: 26
• Arms: 2
• Duration (Months): 5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Lung Disease	Other: walk tests	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Comparison of the Two and Six- Minute Walk Tests in Evaluating Oxygen Desaturation in Patients With Severe COPD
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: May 1, 2007
• Actual Study Completion Date: Aug 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. oxygen desaturation [up to 6 minute walk test]

Secondary Outcome Measures

1. heart rate [during 2 minute walk test and 6 minute walk test]

2. perceived exertion for dyspnea and leg fatigue [during 2 minute walk test and 6 minute walk test]

   measured by a modified Borg scale from 0 to 10

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Schön Klinik Berchtesgadener Land

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Klaus Kenn, MD, Schön Klinik Berchtesgadener Land
• ClinicalTrials.gov Identifier: NCT02462343
• Other Study ID Numbers: walk test trial
• First Posted: Jun 4, 2015
• Last Update Posted: Jun 4, 2015
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Jun 4, 2015