Home
Clinical Trials
NCT01298661

Reliability, Sensitivity and Validity of the 6 Minute Step Test in Chronic Obstructive Pulmonary Disease (COPD) Patients

Last Updated: 2013-11-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Chronic Obstructive Pulmonary Disease (COPD) leads to a reduction in exercise capacity that affects the quality of life and increases mortality of these patients. So, exercise tests are considered as an essential component of the clinical evaluation of the patients with COPD. The objective of this study is to evaluate the reproducibility sensitivity and validity of the Six Minute Step Test (6MST) in patients with COPD and in health volunteers, and verify its relation with the "Body-Mass Index, Airways Obstruction, Dyspnea and Exercise Capacity" Index (BODE). This Observational, Transversal, Prospective study will be conducted in the "Special Unit of Respiratory Physiotherapy", of the "Federal University of São Carlos". To participate in this study, 120 subjects, both gender, will be invited and will be allocated in five groups: Group I (30 healthy young subjects of 17 to 27 years old), Group II (30 healthy elderly individuals of 60 to 75 years old), and patients COPD, 60 to 80 years old, with mild, moderate, severe and very severe obstruction determined by the forced expiratory volume in one second (FEV1) by forced vital capacity (FVC) relation "FEV1/FVC" \<70% and FEV1 in predict percentage \< 80% composing the Group III (20 COPD patients in GOLD stage I), Group IV (20 COPD patients in GOLD stage II) and Group V (20 patients COPD stages III and IV). All subjects will be submitted to body composition and anthropometric assessment, pulmonary function test, three 6-minutes walk test (6MWT) and three 6MST. Furthermore, the patients of the groups III, IV and V will answer the Modified Medical Research Council (mMRC) scale, and BODE index will be calculated to each of them.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Exercise Test Reproducibility of Results Mortality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy Young Subjects

Subjects apparently healthy, with age of 18 to 27 years old.

Group Type OTHER

Six-minute Step Test

Intervention Type OTHER

The patients underwent a test where they need to step up and down a 20cm test during six minutes.

Healthy Elderly subjects

Subjects apparently healthy, with age of 60 to 75 years old.

Group Type OTHER

Six-minute Step Test

Intervention Type OTHER

The patients underwent a test where they need to step up and down a 20cm test during six minutes.

COPD Patients

Patients with clinical and spirometric diagnosis of COPD

Group Type OTHER

Six-minute Step Test

Intervention Type OTHER

The patients underwent a test where they need to step up and down a 20cm test during six minutes.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Six-minute Step Test

The patients underwent a test where they need to step up and down a 20cm test during six minutes.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Exercise Test

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Young and elderly healthy subjects presented pulmonary function within the normal range, confirmed by spirometry
* Patients with clinical and spirometric diagnosis of COPD

Exclusion Criteria

* Lung disease exacerbated
* Decompensated heart disease
* Rheumatic, neurological or orthopedic disease, preventing them from doing the tests by limiting the exercise
* Peripheral oxygen saturation \< 80% without physical effort
* Subjects who does not complete the first day of evaluation

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Valeria Amorim Pires Di Lorenzo

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Valéria Amorim Pires Di Lorenzo, PhD

Role: STUDY_DIRECTOR

Universidade Federal de Sao Carlos

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Unidade Especial de Fisioterapia Respiratória

São Carlos, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

Reference Type BACKGROUND

PMID: 12091180 (View on PubMed)

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. doi: 10.1183/09031936.97.10122807.

Reference Type BACKGROUND

PMID: 9493665 (View on PubMed)

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

Reference Type BACKGROUND

PMID: 7154893 (View on PubMed)

Cahalin LP, Mathier MA, Semigran MJ, Dec GW, DiSalvo TG. The six-minute walk test predicts peak oxygen uptake and survival in patients with advanced heart failure. Chest. 1996 Aug;110(2):325-32. doi: 10.1378/chest.110.2.325.

Reference Type BACKGROUND

PMID: 8697828 (View on PubMed)

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. doi: 10.1590/s1806-37132007000200005. English, Portuguese.

Reference Type BACKGROUND

PMID: 17724530 (View on PubMed)

Casanova C, Cote C, Marin JM, Pinto-Plata V, de Torres JP, Aguirre-Jaime 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):746-752. doi: 10.1378/chest.08-0520. Epub 2008 Jul 14.

Reference Type BACKGROUND

PMID: 18625667 (View on PubMed)

Casas A, Vilaro J, Rabinovich R, Mayer A, Barbera 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. doi: 10.1378/chest.128.1.55.

Reference Type BACKGROUND

PMID: 16002916 (View on PubMed)

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):1005-12. doi: 10.1056/NEJMoa021322.

Reference Type BACKGROUND

PMID: 14999112 (View on PubMed)

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. doi: 10.1183/09031936.00094006. Epub 2006 Oct 18.

Reference Type BACKGROUND

PMID: 17050559 (View on PubMed)

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. doi: 10.1590/s1806-37132006000200012. English, Portuguese.

Reference Type BACKGROUND

PMID: 17273586 (View on PubMed)

Dourado VZ, Antunes LC, Tanni SE, de Paiva SA, Padovani CR, Godoy I. Relationship of upper-limb and thoracic muscle strength to 6-min walk distance in COPD patients. Chest. 2006 Mar;129(3):551-7. doi: 10.1378/chest.129.3.551.

Reference Type BACKGROUND

PMID: 16537851 (View on PubMed)

Enright PL, McBurnie MA, Bittner V, Tracy RP, McNamara R, Arnold A, Newman AB; Cardiovascular Health Study. The 6-min walk test: a quick measure of functional status in elderly adults. Chest. 2003 Feb;123(2):387-98. doi: 10.1378/chest.123.2.387.

Reference Type BACKGROUND

PMID: 12576356 (View on PubMed)

Fromer L, Cooper CB. A review of the GOLD guidelines for the diagnosis and treatment of patients with COPD. Int J Clin Pract. 2008 Aug;62(8):1219-36. doi: 10.1111/j.1742-1241.2008.01807.x. Epub 2008 Jun 28.

Reference Type BACKGROUND

PMID: 18547365 (View on PubMed)

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 chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.

Reference Type BACKGROUND

PMID: 17507545 (View on PubMed)

Soler-Cataluna JJ, Sanchez-Sanchez L, Martinez-Garcia MA, Sanchez PR, Salcedo E, Navarro M. Mid-arm muscle area is a better predictor of mortality than body mass index in COPD. Chest. 2005 Oct;128(4):2108-15. doi: 10.1378/chest.128.4.2108.

Reference Type BACKGROUND

PMID: 16236862 (View on PubMed)

Pitta F, Troosters T, Spruit MA, Probst VS, Decramer M, Gosselink R. Characteristics of physical activities in daily life in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 May 1;171(9):972-7. doi: 10.1164/rccm.200407-855OC. Epub 2005 Jan 21.

Reference Type BACKGROUND

PMID: 15665324 (View on PubMed)

Pinto-Plata VM, Cote C, Cabral H, Taylor J, Celli BR. The 6-min walk distance: change over time and value as a predictor of survival in severe COPD. Eur Respir J. 2004 Jan;23(1):28-33. doi: 10.1183/09031936.03.00034603.

Reference Type BACKGROUND

PMID: 14738227 (View on PubMed)

Mahler DA, Wells CK. Evaluation of clinical methods for rating dyspnea. Chest. 1988 Mar;93(3):580-6. doi: 10.1378/chest.93.3.580.

Reference Type BACKGROUND

PMID: 3342669 (View on PubMed)

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. doi: 10.1378/chest.130.1.119.

Reference Type BACKGROUND

PMID: 16840391 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11451821 (View on PubMed)

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 disease. J Bras Pneumol. 2008 Dec;34(12):1008-18. doi: 10.1590/s1806-37132008001200005. English, Portuguese.

Reference Type BACKGROUND

PMID: 19180335 (View on PubMed)

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. doi: 10.1164/arrd.1983.127.6.725.

Reference Type BACKGROUND

PMID: 6859656 (View on PubMed)

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. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.

Reference Type BACKGROUND

PMID: 16055882 (View on PubMed)

Pessoa BV, Arcuri JF, Labadessa IG, Costa JN, Sentanin AC, Di Lorenzo VA. Validity of the six-minute step test of free cadence in patients with chronic obstructive pulmonary disease. Braz J Phys Ther. 2014 May-Jun;18(3):228-36. doi: 10.1590/bjpt-rbf.2014.0041.

Reference Type DERIVED

PMID: 25003275 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TD6reprod

Identifier Type: -

Identifier Source: org_study_id

Reliability, Sensitivity and Validity of the 6 Minute Step Test in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Healthy Young Subjects

Six-minute Step Test

Healthy Elderly subjects

Six-minute Step Test

COPD Patients

Six-minute Step Test

Interventions

Six-minute Step Test

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Universidade Federal de Sao Carlos

Responsible Party

Valeria Amorim Pires Di Lorenzo

Principal Investigators

Valéria Amorim Pires Di Lorenzo, PhD

Locations

Unidade Especial de Fisioterapia Respiratória

Countries

References

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. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

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. doi: 10.1183/09031936.97.10122807.

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

Cahalin LP, Mathier MA, Semigran MJ, Dec GW, DiSalvo TG. The six-minute walk test predicts peak oxygen uptake and survival in patients with advanced heart failure. Chest. 1996 Aug;110(2):325-32. doi: 10.1378/chest.110.2.325.

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. doi: 10.1590/s1806-37132007000200005. English, Portuguese.

Casanova C, Cote C, Marin JM, Pinto-Plata V, de Torres JP, Aguirre-Jaime 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):746-752. doi: 10.1378/chest.08-0520. Epub 2008 Jul 14.

Casas A, Vilaro J, Rabinovich R, Mayer A, Barbera 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. doi: 10.1378/chest.128.1.55.

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):1005-12. doi: 10.1056/NEJMoa021322.

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. doi: 10.1183/09031936.00094006. Epub 2006 Oct 18.

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. doi: 10.1590/s1806-37132006000200012. English, Portuguese.

Dourado VZ, Antunes LC, Tanni SE, de Paiva SA, Padovani CR, Godoy I. Relationship of upper-limb and thoracic muscle strength to 6-min walk distance in COPD patients. Chest. 2006 Mar;129(3):551-7. doi: 10.1378/chest.129.3.551.

Enright PL, McBurnie MA, Bittner V, Tracy RP, McNamara R, Arnold A, Newman AB; Cardiovascular Health Study. The 6-min walk test: a quick measure of functional status in elderly adults. Chest. 2003 Feb;123(2):387-98. doi: 10.1378/chest.123.2.387.

Fromer L, Cooper CB. A review of the GOLD guidelines for the diagnosis and treatment of patients with COPD. Int J Clin Pract. 2008 Aug;62(8):1219-36. doi: 10.1111/j.1742-1241.2008.01807.x. Epub 2008 Jun 28.

Soler-Cataluna JJ, Sanchez-Sanchez L, Martinez-Garcia MA, Sanchez PR, Salcedo E, Navarro M. Mid-arm muscle area is a better predictor of mortality than body mass index in COPD. Chest. 2005 Oct;128(4):2108-15. doi: 10.1378/chest.128.4.2108.

Pitta F, Troosters T, Spruit MA, Probst VS, Decramer M, Gosselink R. Characteristics of physical activities in daily life in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 May 1;171(9):972-7. doi: 10.1164/rccm.200407-855OC. Epub 2005 Jan 21.

Pinto-Plata VM, Cote C, Cabral H, Taylor J, Celli BR. The 6-min walk distance: change over time and value as a predictor of survival in severe COPD. Eur Respir J. 2004 Jan;23(1):28-33. doi: 10.1183/09031936.03.00034603.

Mahler DA, Wells CK. Evaluation of clinical methods for rating dyspnea. Chest. 1988 Mar;93(3):580-6. doi: 10.1378/chest.93.3.580.

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. doi: 10.1378/chest.130.1.119.

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.

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. doi: 10.1164/arrd.1983.127.6.725.

Pessoa BV, Arcuri JF, Labadessa IG, Costa JN, Sentanin AC, Di Lorenzo VA. Validity of the six-minute step test of free cadence in patients with chronic obstructive pulmonary disease. Braz J Phys Ther. 2014 May-Jun;18(3):228-36. doi: 10.1590/bjpt-rbf.2014.0041.

Other Identifiers

TD6reprod