Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
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.
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