Chronic Obstructive Pulmonary DiseaseNCT01298661

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

A study testing Six-minute Step Test in people with Chronic Obstructive Pulmonary Disease, run by Universidade Federal de Sao Carlos at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Six-minute Step Test
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 1 siteBrazil
Study dates: Feb 2011to Dec 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Unidade Especial de Fisioterapia Respiratória
São Carlos, São Paulo, 13561-206

Other trials in Brazil

About this study

Official title: Evaluation of Reliability, Sensitivity and Validity of the Six Minute Step Test in Patients With Chronic Obstructive Pulmonary Disease and Its Relation With Predictors Markers of Risk of Death

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.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Six-minute Step Test
Keywords: Exercise Test, Reproducibility of Results, Mortality
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Six-minute Step TestOther
Also called Exercise Test
The patients underwent a test where they need to step up and down a 20cm test during six minutes.

Study groups in NCT01298661
Study group	Role	What they receive
Healthy Young Subjects	Other	Subjects apparently healthy, with age of 18 to 27 years old. Receives: Other: Six-minute Step Test
Healthy Elderly subjects	Other	Subjects apparently healthy, with age of 60 to 75 years old. Receives: Other: Six-minute Step Test
COPD Patients	Other	Patients with clinical and spirometric diagnosis of COPD Receives: Other: Six-minute Step Test

What is being measured

The primary outcome is the main question the study is designed to answer.

First "Six Minute Step Test" Performance
This test will be conducted by the "Rater 1", the patient will step up and down a 20cm step during six minute. The performance will be evaluated by the number of the steps.
Measured: First day or second day of the protocol (random)
Second "Six Minute Step Test" Performance
This test will be conducted by the "Rater 1", the patient will step up and down a 20cm step during six minutes. The performance will be evaluated by the number of the climbs.
Measured: On the first or second day of evaluation (random), 30 minutes after the first 6MST.
Third "Six Minute Step Test" Performance
This test will be conducted by the "Rater 2", the patient will step up and down a 20cm step during six minutes. The performance will be evaluated by the number of the climbs.
Measured: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.

Secondary outcomes (22)

First "Six Minute Walk Test" Distance
This test will be conducted by the "Rater 1", the subject will walk as far as it can in a 30m corridor during 6 minutes. The performance will be the distance (meters)that it walk.
Measured: First day or second day of the protocol (random)
Second "Six Minute Walk Test" Distance
This test will be conducted by the "Rater 1", the subject will walk as far as it can in a 30m corridor during 6 minutes. The performance will be the distance (meters)that it walk.
Measured: On the first or second day of evaluation (random), 30 minutes after the first 6MWT.
Third "Six Minute Walk Test" Distance
This test will be conducted by the "Rater 2", the subject will walk as far as it can in a 30m corridor during 6 minutes. The performance will be the distance (meters)that it walk.
Measured: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.
"Body-Mass Index, Airflow Obstruction, Dyspnea, Exercise Capacity" Index (BODE Index)
It was evaluated only in the COPD patients. BODE index is a prognostic index used in COPD patients, it is a 0-10 scale, where lower values means better prognostic. It is composed by other commonly used evaluations tools in COPD, Forced Expiratory Volume in the First second (from spirometry); classification in the scale ranging from 0-3, Body-mass index, classification in the scale ranging from 0-1; Six-minute walk test distance, classification in the scale ranging from 0-3 and referred dyspnea, classification in the scale ranging from 0-3.
It was only used the total score (0-10)
Measured: Second day
First "Six Minute Walk Test" Exertion Perception
This test was conducted by the "Rater 1", the subject walked as far as it could in a 30m corridor during 6 minutes. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort.
Measured: First day or second day of the protocol (random)
Second "Six Minute Walk Test" Exertion Perception
This test will be conducted by the "Rater 1", the subject will walk as far as it can in a 30m corridor during 6 minutes. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort.
Measured: First day or second day of the protocol (random), 30 minutes after the first 6MWT
Third "Six Minute Walk Test" Exertion Perception
This test will be conducted by the "Rater 2", the subject will walk as far as it can in a 30m corridor during 6 minutes. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort.
Measured: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.
First "Six Minute Step Test" Exertion Perception
This test will be conducted by the "Rater 1", the patient will step up and down one 20cm step during six minute. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort.
Measured: First day or second day of the protocol (random)
Second "Six Minute Step Test" Exertion Perception
This test will be conducted by the "Rater 1", the patient will step up and down one 20cm step during six minute.The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort.
Measured: First day or second day of the protocol (random), 30 minutes after the first 6MST
Third "Six Minute Step Test" Exertion Perception
This test will be conducted by the "Rater 2", the patient will step up down one 20cm step during six minute. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort.
Measured: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.
First "Six Minute Walk Test" Peripheral Oxygen Saturation
This test will be conducted by the "Rater 1", the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter.
Measured: First day or second day of the protocol (random)
Second "Six Minute Walk Test" Peripheral Oxygen Saturation
This test will be conducted by the "Rater 1", the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter.
Measured: ,First day or second day of the protocol (random) 30 minutes after the first 6MWT
Third "Six Minute Walk Test" Peripheral Oxygen Saturation
This test will be conducted by the "Rater 2", the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter.
Measured: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.
First "Six Minute Step Test" Peripheral Oxygen Saturation
This test will be conducted by the "Rater 1", the patient will step up and down one 20cm step during six minute. It will be evaluated by a pulse oxymeter.
Measured: First day or second day of the protocol (random)
Second "Six Minute Step Test" Peripheral Oxygen Saturation
This test will be conducted by the "Rater 1", the patient will step up and down one 20cm step during six minute. It will be evaluated by a pulse oxymeter .
Measured: First day or second day of the protocol (random) ,30 minutes after the first 6MST
Third "Six Minute Step Test" Peripheral Oxygen Saturation
This test will be conducted by the "Rater 2", the patient will step up and down one 20cm step during six minute. It will be evaluated by a pulse oxymeter.
Measured: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.
First "Six Minute Walk Test" Heart Rate
This test will be conducted by the "Rater 1", the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a cardio monitor.
Measured: First day or second day of the protocol (random)
Second "Six Minute Walk Test" Heart Rate
This test will be conducted by the "Rater 1", the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a cardio monitor at rest and every two minutes of the test.
Measured: First day or second day of the protocol (random), 30 minutes after the first 6MWT
Third "Six Minute Walk Test" Heart Rate
This test will be conducted by the "Rater 2", the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a cardio monitor.
Measured: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.
First "Six Minute Step Test" Heart Rate
This test will be conducted by the "Rater 1", the patient will step up and down a 20cm step during six minute. It will be evaluated by a cardio monitor.
Measured: First day or second day of the protocol (random)
Second "Six Minute Step Test" Heart Rate
This test will be conducted by the "Rater 1", the patient will step up and down a 20cm step during six minute. It will be evaluated by a cardio monitor.
Measured: First day or second day of the protocol (random), 30 minutes after the first 6MST
Third "Six Minute Step Test" Heart Rate
This test will be conducted by the "Rater 2", the patient will step up and down a 20cm step during six minute. It will be evaluated by a cardio monitor.
Measured: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Dec 2012

First posted18 Feb 2011 (estimated)
Study startFeb 2011
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01298661
Sponsor's protocol ID: TD6reprod
Status last verified: Sep 2013
First submitted: 17 Feb 2011
Last updated: 26 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 12091180
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.
PubMed 9493665
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893
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.
PubMed 8697828
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.
PubMed 17724530
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.
PubMed 18625667
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.
PubMed 16002916
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.
PubMed 14999112
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.
PubMed 17050559
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.
PubMed 17273586
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.
PubMed 16537851
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.
PubMed 12576356
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.
PubMed 18547365
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.
PubMed 17507545
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.
PubMed 16236862

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Reliability, Sensitivity and Validity of the Six Minute Step Test in Patients With Chronic Obstructive Pulmonary Disease and Its Relation With Predictors Markers of Risk of Death
ClinicalTrials.gov ID: NCT01298661
Acronym / sponsor ID: TD6reprod
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Exercise Test, Reproducibility of Results, Mortality
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Universidade Federal de Sao CarlosUniversity, hospital or other
Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico
Study start: Feb 2011
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 18 Feb 2011 (estimated)
Results: Posted 13 Sep 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Healthy Young Subjects	Other	Other: Six-minute Step TestSubjects apparently healthy, with age of 18 to 27 years old.
Healthy Elderly subjects	Other	Other: Six-minute Step TestSubjects apparently healthy, with age of 60 to 75 years old.
COPD Patients	Other	Other: Six-minute Step TestPatients with clinical and spirometric diagnosis of COPD

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Six-minute Step TestAlso: Exercise TestThe patients underwent a test where they need to step up and down a 20cm test during six minutes.	Other	COPD Patients, Healthy Elderly subjects, Healthy Young Subjects

Primary outcome

First "Six Minute Step Test" Performance
Time frame: First day or second day of the protocol (random)
This test will be conducted by the "Rater 1", the patient will step up and down a 20cm step during six minute. The performance will be evaluated by the number of the steps.
Second "Six Minute Step Test" Performance
Time frame: On the first or second day of evaluation (random), 30 minutes after the first 6MST.
This test will be conducted by the "Rater 1", the patient will step up and down a 20cm step during six minutes. The performance will be evaluated by the number of the climbs.
Third "Six Minute Step Test" Performance
Time frame: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.
This test will be conducted by the "Rater 2", the patient will step up and down a 20cm step during six minutes. The performance will be evaluated by the number of the climbs.

22 secondary outcomes

First "Six Minute Walk Test" Distance
Time frame: First day or second day of the protocol (random)
Second "Six Minute Walk Test" Distance
Time frame: On the first or second day of evaluation (random), 30 minutes after the first 6MWT.
Third "Six Minute Walk Test" Distance
Time frame: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.
"Body-Mass Index, Airflow Obstruction, Dyspnea, Exercise Capacity" Index (BODE Index)
Time frame: Second day
First "Six Minute Walk Test" Exertion Perception
Time frame: First day or second day of the protocol (random)
Second "Six Minute Walk Test" Exertion Perception
Time frame: First day or second day of the protocol (random), 30 minutes after the first 6MWT
Third "Six Minute Walk Test" Exertion Perception
Time frame: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.
First "Six Minute Step Test" Exertion Perception
Time frame: First day or second day of the protocol (random)
Second "Six Minute Step Test" Exertion Perception
Time frame: First day or second day of the protocol (random), 30 minutes after the first 6MST
Third "Six Minute Step Test" Exertion Perception
Time frame: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.
First "Six Minute Walk Test" Peripheral Oxygen Saturation
Time frame: First day or second day of the protocol (random)
Second "Six Minute Walk Test" Peripheral Oxygen Saturation
Time frame: ,First day or second day of the protocol (random) 30 minutes after the first 6MWT
Third "Six Minute Walk Test" Peripheral Oxygen Saturation
Time frame: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.
First "Six Minute Step Test" Peripheral Oxygen Saturation
Time frame: First day or second day of the protocol (random)
Second "Six Minute Step Test" Peripheral Oxygen Saturation
Time frame: First day or second day of the protocol (random) ,30 minutes after the first 6MST
Third "Six Minute Step Test" Peripheral Oxygen Saturation
Time frame: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.
First "Six Minute Walk Test" Heart Rate
Time frame: First day or second day of the protocol (random)
Second "Six Minute Walk Test" Heart Rate
Time frame: First day or second day of the protocol (random), 30 minutes after the first 6MWT
Third "Six Minute Walk Test" Heart Rate
Time frame: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.
First "Six Minute Step Test" Heart Rate
Time frame: First day or second day of the protocol (random)
Second "Six Minute Step Test" Heart Rate
Time frame: First day or second day of the protocol (random), 30 minutes after the first 6MST
Third "Six Minute Step Test" Heart Rate
Time frame: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.

Results and safety

Results posted to the registry on 13 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Young Subjects	33	31
Healthy Elderly Subjects	24	24
COPD Patients	34	32

Primary outcome: First "Six Minute Step Test" Performance

Time frame: First day or second day of the protocol (random). Mean (Standard Deviation). Unit: steps

Measure	Healthy Young Subjects n = 31	Healthy Elderly Subjects n = 24	COPD Patients n = 32
Value	166.4 (36.4)	114.0 (29.2)	76.6 (19.6)

Population analysed: 2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.

Primary outcome: Second "Six Minute Step Test" Performance

Time frame: On the first or second day of evaluation (random), 30 minutes after the first 6MST.. Mean (Standard Deviation). Unit: steps

Measure	Healthy Young Subjects n = 31	Healthy Elderly Subjects n = 24	COPD Patients n = 32
Value	170.7 (40.6)	114.5 (33.5)	82.4 (20.7)

Population analysed: 2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.

Primary outcome: Third "Six Minute Step Test" Performance

Time frame: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.. Mean (Standard Deviation). Unit: steps

Measure	Healthy Young Subjects n = 31	Healthy Elderly Subjects n = 19	COPD Patients n = 29
Value	172.3 (36.3)	111.3 (32.9)	86.4 (22.0)

Population analysed: 2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.

22 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Young Subjects	0 of 0	0 of 0	Not reported
Healthy Elderly Subjects	0 of 0	0 of 0	Not reported
COPD Patients	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): The enrolled patient's and subject's numbers were smaller than the estimated for healthy elders and different COPD groups, because of the low acceptance of a three days evaluation protocol. So COPD patients were analyzed in a single group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12091180ATS 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.
Background: PubMed 9493665Baarends 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.
Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
Background: PubMed 8697828Cahalin 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.
Background: PubMed 17724530Cataneo 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.
Background: PubMed 18625667Casanova 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.
Background: PubMed 16002916Casas 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.
Background: PubMed 14999112Celli 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.
Background: PubMed 17050559Dal 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.
Background: PubMed 17273586Dourado 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.
Background: PubMed 16537851Dourado 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.
Background: PubMed 12576356Enright 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Valéria Amorim Pires Di Lorenzo, PhD study director

Universidade Federal de Sao Carlos

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Six-minute Step Test in people with Chronic Obstructive Pulmonary Disease, run by Universidade Federal de Sao Carlos at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First "Six Minute Step Test" Performance (time frame: First day or second day of the protocol (random)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01298661, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2013.