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Sponsored by: |
Wake Forest University |
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Information provided by: | Wake Forest University |
ClinicalTrials.gov Identifier: | NCT00740220 |
This trial will test the hypothesis that the 6 minute walk test (6MWT) is not reproducible as a measure for oxygen desaturation.
Condition |
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Hypoxemia Anoxia Pulmonary Disease Chronic Obstructive |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Reproducibility of 6 Minute Walk Tests for Oxygen Desaturation |
Estimated Enrollment: | 200 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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A
Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested.
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Over 16million 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
This study will be carried out in a population of subjects who are taking part in Pulmonary Rehabilitation.
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Wake Forest University Health Sciences | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | Arjun B Chatterjee, MD, MS | Wake Forest University |
Responsible Party: | Wake Forest University Health Sciences ( Arjun Chatterjee ) |
Study ID Numbers: | BG02-489 |
Study First Received: | August 20, 2008 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00740220 |
Health Authority: | United States: Institutional Review Board |
hypoxemia anoxia oxygen |
dyspnea pulmonary disease chronic obstructive |
Signs and Symptoms Respiratory Tract Diseases Lung Diseases Respiration Disorders |
Signs and Symptoms, Respiratory Dyspnea Anoxia |