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6MWT: Reproducibility of 6 Minute Walk Tests for Oxygen Desaturation

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT00740220
Collaborator
(none)
97
Enrollment
1
Location
28
Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    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 :
    Sep 1, 2006
    Actual Primary Completion Date :
    Jan 1, 2009
    Actual Study Completion Date :
    Jan 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    A

    Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Taking part in Pulmonary Rehabilitation
    Exclusion Criteria:
    • Inability to perform 6MWT

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University Health Sciences

    Investigators

    • Principal Investigator: Arjun B Chatterjee, MD, MS, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT00740220
    Other Study ID Numbers:
    • BG02-489
    First Posted:
    Aug 22, 2008
    Last Update Posted:
    Dec 15, 2017
    Last Verified:
    Apr 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Wake Forest University Health Sciences
    hypoxemia
    anoxia
    oxygen
    dyspnea
    pulmonary disease
    chronic obstructive
    Additional relevant MeSH terms:
    Lung Diseases
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive
    Hypoxia

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Single Arm Prospective Observational Study
    Arm/Group Description Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
    Period Title: Overall Study
    STARTED 97
    COMPLETED 88
    NOT COMPLETED 9

    Baseline Characteristics

    Arm/Group Title Single Arm Prospective Observational Study
    Arm/Group Description Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
    Overall Participants 97
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    45
    46.4%
    >=65 years
    52
    53.6%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    70
    (11)
    Sex: Female, Male (Count of Participants)
    Female
    60
    61.9%
    Male
    37
    38.1%
    Region of Enrollment (participants) [Number]
    United States
    97
    100%

    Outcome Measures

    1. Primary Outcome
    Title Kappa Statistic for Correlation of the Oxygen Saturation Across 3 Serial 6 Minute Walk Tests (6MWT)
    Description The kappa statistic is a measure of the quality of a test. It is a ratio.
    Time Frame All three 6MWTs should take place within 30 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Single Arm Prospective Observational Study
    Arm/Group Description Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
    Measure Participants 88
    Number [Ratio]
    0.62

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Single Arm Prospective Observational Study
    Arm/Group Description Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
    All Cause Mortality
    Single Arm Prospective Observational Study
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Single Arm Prospective Observational Study
    Affected / at Risk (%) # Events
    Total 0/88 (0%)
    Other (Not Including Serious) Adverse Events
    Single Arm Prospective Observational Study
    Affected / at Risk (%) # Events
    Total 0/88 (0%)

    Limitations/Caveats

    Study was conducted in a Pulmonary Rehabilitation Population and may not be generalizable.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Arjun Chatterjee, MD, MS, FCCP
    Organization Wake Forest University
    Phone 336.716.4649
    Email achatter@wfubmc.edu
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT00740220
    Other Study ID Numbers:
    • BG02-489
    First Posted:
    Aug 22, 2008
    Last Update Posted:
    Dec 15, 2017
    Last Verified:
    Apr 1, 2016