Reproducibility of 6 Minute Walk Tests for Oxygen Desaturation (6MWT)
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| ClinicalTrials.gov Identifier: NCT00740220 |
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Recruitment Status :
Completed
First Posted : August 22, 2008
Results First Posted : April 20, 2009
Last Update Posted : December 15, 2017
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| Condition or disease |
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| Hypoxemia Anoxia Chronic Obstructive Pulmonary Disease |
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 Type : | Observational |
| Actual Enrollment : | 97 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Reproducibility of 6 Minute Walk Tests for Oxygen Desaturation |
| Study Start Date : | September 2006 |
| Actual Primary Completion Date : | January 2009 |
| Actual Study Completion Date : | January 2009 |
| Group/Cohort |
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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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- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Taking part in Pulmonary Rehabilitation
Exclusion Criteria:
- Inability to perform 6MWT
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
| 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 Health Sciences |
Publications:
| Responsible Party: | Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT00740220 History of Changes |
| Other Study ID Numbers: |
BG02-489 |
| First Posted: | August 22, 2008 Key Record Dates |
| Results First Posted: | April 20, 2009 |
| Last Update Posted: | December 15, 2017 |
| 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 Wake Forest University Health Sciences:
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hypoxemia anoxia oxygen |
dyspnea pulmonary disease chronic obstructive |
Additional relevant MeSH terms:
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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Hypoxia |
Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |