Comparison of the Two and Six- Minute Walk Tests in Evaluating Oxygen Desaturation in Patients With Severe COPD
Primary Purpose
Chronic Obstructive Lung Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
walk tests
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Obstructive Lung Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
2 minute walk test
6 minute walk test
Arm Description
Outcomes
Primary Outcome Measures
oxygen desaturation
Secondary Outcome Measures
heart rate
perceived exertion for dyspnea and leg fatigue
measured by a modified Borg scale from 0 to 10
Full Information
NCT ID
NCT02462343
First Posted
June 2, 2015
Last Updated
June 3, 2015
Sponsor
Schön Klinik Berchtesgadener Land
1. Study Identification
Unique Protocol Identification Number
NCT02462343
Brief Title
Comparison of the Two and Six- Minute Walk Tests in Evaluating Oxygen Desaturation in Patients With Severe COPD
Official Title
Comparison of the Two and Six- Minute Walk Tests in Evaluating Oxygen Desaturation in Patients With Severe COPD
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Lung Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2 minute walk test
Arm Type
Other
Arm Title
6 minute walk test
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
walk tests
Primary Outcome Measure Information:
Title
oxygen desaturation
Time Frame
up to 6 minute walk test
Secondary Outcome Measure Information:
Title
heart rate
Time Frame
during 2 minute walk test and 6 minute walk test
Title
perceived exertion for dyspnea and leg fatigue
Description
measured by a modified Borg scale from 0 to 10
Time Frame
during 2 minute walk test and 6 minute walk test
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, MD
Organizational Affiliation
Schoen Klinik Berchtesgadener Land
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Two and Six- Minute Walk Tests in Evaluating Oxygen Desaturation in Patients With Severe COPD
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