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Reproducibility of 6 Minute Walk Tests for Oxygen Desaturation (6MWT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00740220
First Posted: August 22, 2008
Last Update Posted: May 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
arjun Bijoy chatterjee, Wake Forest School of Medicine
  Purpose
This trial will test the hypothesis that the 6 minute walk test (6MWT) is not reproducible as a measure for oxygen desaturation.

Condition
Hypoxemia Anoxia Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reproducibility of 6 Minute Walk Tests for Oxygen Desaturation

Resource links provided by NLM:


Further study details as provided by arjun Bijoy chatterjee, Wake Forest School of Medicine:

Primary Outcome Measures:
  • Kappa Statistic for Correlation of the Oxygen Saturation Across 3 Serial 6 Minute Walk Tests (6MWT) [ Time Frame: All three 6MWTs should take place within 30 days ]
    The kappa statistic is a measure of the quality of a test. It is a ratio.


Enrollment: 97
Study Start Date: September 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested.

Detailed Description:

Over 16 million adults in the United States are afflicted with chronic obstructive pulmonary disease (COPD) and is the fourth leading cause of death.(McCrory et al. 1190-209). COPD accounts for direct health-care costs of $18 billion.(McCrory et al. 1190-209). Oxygen therapy has been shown to decrease mortality in COPD patients with severe hypoxemia at rest. Oxygen therapy now accounts for the number one expenditure for durable medical equipment. Current requirements for oxygen therapy for COPD patients include a resting or exercise paO2 or spO2 of 55 mmHg or 88% respectively. We have shown that a resting spO2 of < 95% is predictive of those at risk of exercise induced hypoxemia in COPD patients(Knower et al. 732-36) based on continuous spO2 monitoring during a 6 minute walk. Although, the reproducibility of a 6 minute walk has been addressed in terms of a hospital test, simulated home test and actual home test (Guyatt), its inter-variability is not well studied.

We propose to investigate the reliability and inter-variability of the 6 minute walk for oxygen prescription. Currently, two programs are providing pulmonary rehabilitation for COPD patients in the community. Patients perform 6 minute walks under supervision and are monitored by pulse oximetry on a routine basis as part of these programs. We plan to capture the oximetry data in order to determine the reliability of oxygen prescriptions using the 6 minute walk. Patients who are performing a 6 minute walk will be eligible for enrollment. Protocols for the 6 minute walk are already in place and approved by their respective authority in both of the Pulmonary Rehabilitation Programs. These patients will have repeat 6 minute walks on separate in close proximity to determine the reliability of spO2 on any given day. Statistical analysis will be done by the kappa statistic for inter-test agreement in a 3 dimensional matrix.

We ask to waive consent for this study as there is no change to the daily routine of the 6 minute walks already being done as part of Pulmonary Rehabilitation. We plan only to capture the data from these walks.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will be carried out in a population of subjects who are taking part in Pulmonary Rehabilitation.
Criteria

Inclusion Criteria:

  • Taking part in Pulmonary Rehabilitation

Exclusion Criteria:

  • Inability to perform 6MWT
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740220


Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Arjun B Chatterjee, MD, MS Wake Forest University Health Sciences
  More Information

Publications:

Responsible Party: arjun Bijoy chatterjee, Associate Professor of Medicine, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT00740220     History of Changes
Other Study ID Numbers: BG02-489
First Submitted: August 20, 2008
First Posted: August 22, 2008
Results First Submitted: February 13, 2009
Results First Posted: April 20, 2009
Last Update Posted: May 30, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data could only be shared if requestor had IRB approval and funding to re-contact all participants for permission.

Keywords provided by arjun Bijoy chatterjee, Wake Forest School of Medicine:
hypoxemia
anoxia
oxygen
dyspnea
pulmonary disease
chronic obstructive

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Anoxia
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms