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

This study has been completed.
Sponsor:
Information provided by:
Wake Forest University
ClinicalTrials.gov Identifier:
NCT00740220
First received: August 20, 2008
Last updated: January 13, 2010
Last verified: April 2009

August 20, 2008
January 13, 2010
September 2006
January 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Kappa statistic for correlation of the oxygen saturation across 3 serial 6MWTs [ Time Frame: All 3 6MWTs should occur within 30 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00740220 on ClinicalTrials.gov Archive Site
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Reproducibility of 6 Minute Walk Tests for Oxygen Desaturation
Reproducibility of 6 Minute Walk Tests for Oxygen Desaturation

This trial will test the hypothesis that the 6 minute walk test (6MWT) is not reproducible as a measure for oxygen desaturation.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

This study will be carried out in a population of subjects who are taking part in Pulmonary Rehabilitation.

  • Hypoxemia
  • Anoxia
  • Chronic Obstructive Pulmonary Disease
Not Provided
A
Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Taking part in Pulmonary Rehabilitation

Exclusion Criteria:

  • Inability to perform 6MWT
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00740220
BG02-489
No
Arjun Chatterjee, Wake Forest University Health Sciences
Wake Forest University
Not Provided
Principal Investigator: Arjun B Chatterjee, MD, MS Wake Forest University
Wake Forest University
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP