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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00660738
Other study ID # 074/2007
Secondary ID
Status Completed
Phase N/A
First received April 10, 2008
Last updated January 22, 2012
Start date January 2007
Est. completion date February 2008

Study information

Verified date January 2012
Source Universidade Federal de Sao Carlos
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial Summary

Objectives: to evaluate and compare the responses to the various functional tests, and the concordance between the six-minute walk test in hallway (6MWT) and the of oval track (6MWToT), of treadmill (6MWTT), and of treadmill with inclination (6MWTTI), the six-minute step test (6MST) and the sit-to-stand test (STST), in patients with Chronic Obstructive Pulmonary Disease (COPD), and to correlate the responses with functional state and quality of life. Methods: Ten patients with COPD (71±8years, FEV1<80%predicted) were assessed using the functional tests. A dyspnea was assessed using the London Chest Activity of Daily Living and the Medical Research Council scales; and the quality of life was assessed using the St George's Respiratory Questionnaire (SGRQ).


Description:

Results: In the interests analysis, there was lower walking distance in the 6MWTT and 6MWTTI was observed, to compare in the 6MWT and 6MWToT; the ΔSp,O2 (delta of arterial oxygen saturation measured by pulse oximeter) in the 6MWTTI was significantly greater that in the 6MWT, but not between to change in dyspnea and fatigue/pain in the lower-limbs between rest and exercise of peak (Δ). Concordance and correlation was observed between the lower Sp,O2 of the 6MWT with the 6MWToT, 6MWTT, 6MWTTI, 6MST and STST. Strong correlations was observed between the performances on the 6MST and 6MWT, 6MWToT and 6MWTT; and between the physical activity domain of the SGRQ with the performances in the 6MWT, 6MWToT, 6MWTT,6MST and STST. Conclusion: The functional tests produced similar subjective responses; however, the 6MWTTI caused greater desaturation that 6MWT. The concordance between the 6MWT and the tests performed, suggests acceptable use of any these tests in the physiotherapeutic clinical routine of the individuals COPD. The tests in performed, except the 6MWTTI, shown to be indicators of the quality of life (physical activity domain).


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date February 2008
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender Male
Age group 55 Years to 81 Years
Eligibility Inclusion Criteria:

- Tiffeneau index<70% e 30%<FEV1<80% predict;

- no presenting exacerbation during the study period;

- clinical stability for the four weeks preceding the study outset;

- no-smokers or ex-smokers.

Exclusion Criteria:

- being incapable of understanding the scales and questionary;

- being unable to perform the tests.

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Brazil Special Unit of Respiratory Physiotherapy of Federal University of Sao Carlos (UFSCar) São Carlos São Paulo

Sponsors (2)

Lead Sponsor Collaborator
Universidade Federal de Sao Carlos Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

References & Publications (25)

ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. — View Citation

Baarends EM, Schols AM, Mostert R, Wouters EF. Peak exercise response in relation to tissue depletion in patients with chronic obstructive pulmonary disease. Eur Respir J. 1997 Dec;10(12):2807-13. — View Citation

Borel B, Fabre C, Saison S, Bart F, Grosbois JM. An original field evaluation test for chronic obstructive pulmonary disease population: the six-minute stepper test. Clin Rehabil. 2010 Jan;24(1):82-93. doi: 10.1177/0269215509343848. — View Citation

Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81. — View Citation

Brown SE, Casciari RJ, Light RW. Arterial oxygen saturation during meals in patients with severe chronic obstructive pulmonary disease. South Med J. 1983 Feb;76(2):194-8. — View Citation

Casanova C, Cote C, Marin JM, Pinto-Plata V, de Torres JP, Aguirre-Jaíme A, Vassaux C, Celli BR. Distance and oxygen desaturation during the 6-min walk test as predictors of long-term mortality in patients with COPD. Chest. 2008 Oct;134(4):746-52. doi: 10 — View Citation

Casas A, Vilaro J, Rabinovich R, Mayer A, Barberà JA, Rodriguez-Roisin R, Roca J. Encouraged 6-min walking test indicates maximum sustainable exercise in COPD patients. Chest. 2005 Jul;128(1):55-61. — View Citation

Cataneo DC, Cataneo AJ. Accuracy of the stair climbing test using maximal oxygen uptake as the gold standard. J Bras Pneumol. 2007 Mar-Apr;33(2):128-33. English, Portuguese. — View Citation

Cataneo DC, Kobayasi S, Carvalho LR, Paccanaro RC, Cataneo AJ. Accuracy of six minute walk test, stair test and spirometry using maximal oxygen uptake as gold standard. Acta Cir Bras. 2010 Apr;25(2):194-200. — View Citation

Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-1 — View Citation

Dal Corso S, Duarte SR, Neder JA, Malaguti C, de Fuccio MB, de Castro Pereira CA, Nery LE. A step test to assess exercise-related oxygen desaturation in interstitial lung disease. Eur Respir J. 2007 Feb;29(2):330-6. Epub 2006 Oct 18. — View Citation

Dourado VZ, Tanni SE, Vale SA, Faganello MM, Sanchez FF, Godoy I. Systemic manifestations in chronic obstructive pulmonary disease. J Bras Pneumol. 2006 Mar-Apr;32(2):161-71. Review. English, Portuguese. — View Citation

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. — View Citation

Knudson RJ, Lebowitz MD, Holberg CJ, Burrows B. Changes in the normal maximal expiratory flow-volume curve with growth and aging. Am Rev Respir Dis. 1983 Jun;127(6):725-34. — View Citation

Kovelis D, Segretti NO, Probst VS, Lareau SC, Brunetto AF, Pitta F. Validation of the Modified Pulmonary Functional Status and Dyspnea Questionnaire and the Medical Research Council scale for use in Brazilian patients with chronic obstructive pulmonary di — View Citation

Leung AS, Chan KK, Sykes K, Chan KS. Reliability, validity, and responsiveness of a 2-min walk test to assess exercise capacity of COPD patients. Chest. 2006 Jul;130(1):119-25. — View Citation

Mahler DA, Wells CK. Evaluation of clinical methods for rating dyspnea. Chest. 1988 Mar;93(3):580-6. — View Citation

Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisat — View Citation

Montes de Oca M, Ortega Balza M, Lezama J, López JM. [Chronic obstructive pulmonary disease: evaluation of exercise tolerance using three different exercise tests]. Arch Bronconeumol. 2001 Feb;37(2):69-74. Spanish. — View Citation

Oga T, Nishimura K, Tsukino M, Hajiro T, Ikeda A, Mishima M. Relationship between different indices of exercise capacity and clinical measures in patients with chronic obstructive pulmonary disease. Heart Lung. 2002 Sep-Oct;31(5):374-81. — View Citation

Ozalevli S, Ozden A, Itil O, Akkoclu A. Comparison of the Sit-to-Stand Test with 6 min walk test in patients with chronic obstructive pulmonary disease. Respir Med. 2007 Feb;101(2):286-93. Epub 2006 Jun 27. — View Citation

Poulain M, Durand F, Palomba B, Ceugniet F, Desplan J, Varray A, Préfaut C. 6-minute walk testing is more sensitive than maximal incremental cycle testing for detecting oxygen desaturation in patients with COPD. Chest. 2003 May;123(5):1401-7. — View Citation

Puente-Maestu L, García de Pedro J, Martínez-Abad Y, Ruíz de Oña JM, Llorente D, Cubillo JM. Dyspnea, ventilatory pattern, and changes in dynamic hyperinflation related to the intensity of constant work rate exercise in COPD. Chest. 2005 Aug;128(2):651-6. — View Citation

Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chron — View Citation

Takigawa N, Tada A, Soda R, Date H, Yamashita M, Endo S, Takahashi S, Kawata N, Shibayama T, Hamada N, Sakaguchi M, Hirano A, Kimura G, Okada C, Takahashi K. Distance and oxygen desaturation in 6-min walk test predict prognosis in COPD patients. Respir Me — View Citation

* Note: There are 25 references in allClick here to view all references

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