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

Chronic Obstructive Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462343
• Other study ID #: walk test trial
• Status: Completed
• Phase: N/A
• First received: June 2, 2015
• Last updated: June 3, 2015
• Start date: March 2007
• Est. completion date: August 2007

Study information

• Verified date: June 2015
• Source: Klinikum Berchtesgadener Land der Schön-Kliniken
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Obstructive Lung Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• walk tests

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Berchtesgadener Land der Schön-Kliniken

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygen desaturation		up to 6 minute walk test	Yes
Secondary	heart rate		during 2 minute walk test and 6 minute walk test	No
Secondary	perceived exertion for dyspnea and leg fatigue	measured by a modified Borg scale from 0 to 10	during 2 minute walk test and 6 minute walk test	No