NCT00740220

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
4 months until next milestone

Results Posted

Study results publicly available

April 20, 2009

Completed
Last Updated

December 15, 2017

Status Verified

April 1, 2016

Enrollment Period

2.3 years

First QC Date

August 20, 2008

Results QC Date

February 13, 2009

Last Update Submit

November 6, 2017

Conditions

Keywords

hypoxemiaanoxiaoxygendyspneapulmonary diseasechronic obstructive

Outcome Measures

Primary Outcomes (1)

  • Kappa Statistic for Correlation of the Oxygen Saturation Across 3 Serial 6 Minute Walk Tests (6MWT)

    The kappa statistic is a measure of the quality of a test. It is a ratio.

    All three 6MWTs should take place within 30 days

Study Arms (1)

A

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will be carried out in a population of subjects who are taking part in Pulmonary Rehabilitation.

You may qualify if:

  • Taking part in Pulmonary Rehabilitation

You may not qualify if:

  • Inability to perform 6MWT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (34)

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    PMID: 6776858BACKGROUND
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    PMID: 16235359BACKGROUND
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    PMID: 18625667BACKGROUND
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    PMID: 14999112BACKGROUND
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    PMID: 16614349BACKGROUND
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    PMID: 18641094BACKGROUND
  • Dunne PJ. The demographics and economics of long-term oxygen therapy. Respir Care. 2000 Feb;45(2):223-8; discussion 228-30.

    PMID: 10771794BACKGROUND
  • Eaton T, Young P, Milne D, Wells AU. Six-minute walk, maximal exercise tests: reproducibility in fibrotic interstitial pneumonia. Am J Respir Crit Care Med. 2005 May 15;171(10):1150-7. doi: 10.1164/rccm.200405-578OC. Epub 2005 Jan 7.

    PMID: 15640367BACKGROUND
  • Eiser N, Willsher D, Dore CJ. Reliability, repeatability and sensitivity to change of externally and self-paced walking tests in COPD patients. Respir Med. 2003 Apr;97(4):407-14. doi: 10.1053/rmed.2002.1462.

    PMID: 12693802BACKGROUND
  • Emtner M, Porszasz J, Burns M, Somfay A, Casaburi R. Benefits of supplemental oxygen in exercise training in nonhypoxemic chronic obstructive pulmonary disease patients. Am J Respir Crit Care Med. 2003 Nov 1;168(9):1034-42. doi: 10.1164/rccm.200212-1525OC. Epub 2003 Jul 17.

    PMID: 12869359BACKGROUND
  • Enright PL, Sherrill DL. Reference equations for the six-minute walk in healthy adults. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1384-7. doi: 10.1164/ajrccm.158.5.9710086.

    PMID: 9817683BACKGROUND
  • Escourrou PJ, Delaperche MF, Visseaux A. Reliability of pulse oximetry during exercise in pulmonary patients. Chest. 1990 Mar;97(3):635-8. doi: 10.1378/chest.97.3.635.

    PMID: 2106411BACKGROUND
  • Garcia-Talavera I, Garcia CH, Macario CC, de Torres JP, Celli BR, Aguirre-Jaime A. Time to desaturation in the 6-min walking distance test predicts 24-hour oximetry in COPD patients with a PO2 between 60 and 70mmHg. Respir Med. 2008 Jul;102(7):1026-32. doi: 10.1016/j.rmed.2008.02.004. Epub 2008 Mar 17.

    PMID: 18343649BACKGROUND
  • Guyatt GH, Nonoyama M, Lacchetti C, Goeree R, McKim D, Heels-Ansdell D, Goldstein R. A randomized trial of strategies for assessing eligibility for long-term domiciliary oxygen therapy. Am J Respir Crit Care Med. 2005 Sep 1;172(5):573-80. doi: 10.1164/rccm.200412-1692OC. Epub 2005 May 18.

    PMID: 15901604BACKGROUND
  • Guyatt GH, McKim DA, Austin P, Bryan R, Norgren J, Weaver B, Goldstein RS. Appropriateness of domiciliary oxygen delivery. Chest. 2000 Nov;118(5):1303-8. doi: 10.1378/chest.118.5.1303.

    PMID: 11083678BACKGROUND
  • Hadeli KO, Siegel EM, Sherrill DL, Beck KC, Enright PL. Predictors of oxygen desaturation during submaximal exercise in 8,000 patients. Chest. 2001 Jul;120(1):88-92. doi: 10.1378/chest.120.1.88.

    PMID: 11451821BACKGROUND
  • Lewis CA, Eaton TE, Fergusson W, Whyte KF, Garrett JE, Kolbe J. Home overnight pulse oximetry in patients with COPD: more than one recording may be needed. Chest. 2003 Apr;123(4):1127-33. doi: 10.1378/chest.123.4.1127.

    PMID: 12684303BACKGROUND
  • MacIntyre NR. Oxygen therapy and exercise response in lung disease. Respir Care. 2000 Feb;45(2):194-200; discussion 201-3.

    PMID: 10771791BACKGROUND
  • Mak VH, Bugler JR, Roberts CM, Spiro SG. Effect of arterial oxygen desaturation on six minute walk distance, perceived effort, and perceived breathlessness in patients with airflow limitation. Thorax. 1993 Jan;48(1):33-8. doi: 10.1136/thx.48.1.33.

    PMID: 8434350BACKGROUND
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    PMID: 8625659BACKGROUND
  • O'Donohue WJ Jr, Plummer AL. Magnitude of usage and cost of home oxygen therapy in the United States. Chest. 1995 Feb;107(2):301-2. doi: 10.1378/chest.107.2.301. No abstract available.

    PMID: 7842750BACKGROUND
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    PMID: 12740254BACKGROUND
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    PMID: 16636528BACKGROUND
  • Rooyackers JM, Dekhuijzen PN, Van Herwaarden CL, Folgering HT. Training with supplemental oxygen in patients with COPD and hypoxaemia at peak exercise. Eur Respir J. 1997 Jun;10(6):1278-84. doi: 10.1183/09031936.97.10061278.

    PMID: 9192929BACKGROUND
  • Sciurba F, Criner GJ, Lee SM, Mohsenifar Z, Shade D, Slivka W, Wise RA; National Emphysema Treatment Trial Research Group. Six-minute walk distance in chronic obstructive pulmonary disease: reproducibility and effect of walking course layout and length. Am J Respir Crit Care Med. 2003 Jun 1;167(11):1522-7. doi: 10.1164/rccm.200203-166OC. Epub 2003 Feb 20.

    PMID: 12615634BACKGROUND
  • Timms RM, Kvale PA, Anthonisen NR, Boylen CT, Cugell DW, Petty TL, Williams GW. Selection of patients with chronic obstructive pulmonary disease for long-term oxygen therapy. JAMA. 1981 Jun 26;245(24):2514-5.

    PMID: 7014957BACKGROUND
  • Ram FS, Wedzicha JA. Ambulatory oxygen for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2002;(2):CD000238. doi: 10.1002/14651858.CD000238.

    PMID: 12076387BACKGROUND
  • Zielinski J, Tobiasz M, Hawrylkiewicz I, Sliwinski P, Palasiewicz G. Effects of long-term oxygen therapy on pulmonary hemodynamics in COPD patients: a 6-year prospective study. Chest. 1998 Jan;113(1):65-70. doi: 10.1378/chest.113.1.65.

    PMID: 9440570BACKGROUND
  • Budweiser S, Heidtkamp F, Jorres RA, Heinemann F, Arzt M, Schroll S, Schmidbauer K, Hitzl AP, Pfeifer M. Predictive significance of the six-minute walk distance for long-term survival in chronic hypercapnic respiratory failure. Respiration. 2008;75(4):418-26. doi: 10.1159/000109662. Epub 2007 Oct 9.

    PMID: 17934248BACKGROUND

MeSH Terms

Conditions

HypoxiaPulmonary Disease, Chronic ObstructiveDyspneaLung Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesRespiration Disorders

Limitations and Caveats

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

Results Point of Contact

Title
Arjun Chatterjee, MD, MS, FCCP
Organization
Wake Forest University

Study Officials

  • Arjun B Chatterjee, MD, MS

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 22, 2008

Study Start

September 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

December 15, 2017

Results First Posted

April 20, 2009

Record last verified: 2016-04

Locations