Reproducibility of 6 Minute Walk Tests for Oxygen Desaturation

Completed

• Conditions: Hypoxemia; Anoxia; Chronic Obstructive Pulmonary Disease

• Registration Number: NCT00740220
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2008-08-20
• Study First Submitted QC: 2008-08-20
• Study First Posted: 2008-08-22
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Results First Submitted: 2009-02-13
• Results First Submitted QC: 2009-03-13
• Results First Posted: 2009-04-20
• Status Verified: 2016-04
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• Taking part in Pulmonary Rehabilitation

Exclusion Criteria

• Inability to perform 6MWT

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Kappa Statistic for Correlation of the Oxygen Saturation Across 3 Serial 6 Minute Walk Tests (6MWT)	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.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States