search
Back to results

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
Schön Klinik Berchtesgadener Land
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Obstructive Lung Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 2, 2015
    Last Updated
    June 3, 2015
    Sponsor
    Schön Klinik Berchtesgadener Land
    search

    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

    We'll reach out to this number within 24 hrs