Reliability, Sensitivity and Validity of the 6 Minute Step Test in Chronic Obstructive Pulmonary Disease (COPD) Patients
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
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
São Paulo
-
São Carlos、São Paulo、巴西、13561-206
- Unidade Especial de Fisioterapia Respiratória
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
其他:Healthy Young Subjects
Subjects apparently healthy, with age of 18 to 27 years old.
|
The patients underwent a test where they need to step up and down a 20cm test during six minutes.
其他名称:
|
其他:Healthy Elderly subjects
Subjects apparently healthy, with age of 60 to 75 years old.
|
The patients underwent a test where they need to step up and down a 20cm test during six minutes.
其他名称:
|
其他:COPD Patients
Patients with clinical and spirometric diagnosis of COPD
|
The patients underwent a test where they need to step up and down a 20cm test during six minutes.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
First "Six Minute Step Test" Performance
大体时间: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.
|
First day or second day of the protocol (random)
|
Second "Six Minute Step Test" Performance
大体时间: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.
|
On the first or second day of evaluation (random), 30 minutes after the first 6MST.
|
Third "Six Minute Step Test" Performance
大体时间: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.
|
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.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
First "Six Minute Walk Test" Distance
大体时间:First day or second day of the protocol (random)
|
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.
|
First day or second day of the protocol (random)
|
Second "Six Minute Walk Test" Distance
大体时间:On the first or second day of evaluation (random), 30 minutes after the first 6MWT.
|
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.
|
On the first or second day of evaluation (random), 30 minutes after the first 6MWT.
|
Third "Six Minute Walk Test" Distance
大体时间: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.
|
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.
|
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)
大体时间:Second day
|
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) |
Second day
|
First "Six Minute Walk Test" Exertion Perception
大体时间:First day or second day of the protocol (random)
|
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.
|
First day or second day of the protocol (random)
|
Second "Six Minute Walk Test" Exertion Perception
大体时间:First day or second day of the protocol (random), 30 minutes after the first 6MWT
|
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.
|
First day or second day of the protocol (random), 30 minutes after the first 6MWT
|
Third "Six Minute Walk Test" Exertion Perception
大体时间: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.
|
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.
|
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
大体时间: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 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.
|
First day or second day of the protocol (random)
|
Second "Six Minute Step Test" Exertion Perception
大体时间:First day or second day of the protocol (random), 30 minutes after the first 6MST
|
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.
|
First day or second day of the protocol (random), 30 minutes after the first 6MST
|
Third "Six Minute Step Test" Exertion Perception
大体时间: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 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.
|
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
大体时间:First day or second day of the protocol (random)
|
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.
|
First day or second day of the protocol (random)
|
Second "Six Minute Walk Test" Peripheral Oxygen Saturation
大体时间:,First day or second day of the protocol (random) 30 minutes after the first 6MWT
|
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.
|
,First day or second day of the protocol (random) 30 minutes after the first 6MWT
|
Third "Six Minute Walk Test" Peripheral Oxygen Saturation
大体时间: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.
|
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.
|
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
大体时间: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 one 20cm step during six minute.
It will be evaluated by a pulse oxymeter.
|
First day or second day of the protocol (random)
|
Second "Six Minute Step Test" Peripheral Oxygen Saturation
大体时间:First day or second day of the protocol (random) ,30 minutes after the first 6MST
|
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 .
|
First day or second day of the protocol (random) ,30 minutes after the first 6MST
|
Third "Six Minute Step Test" Peripheral Oxygen Saturation
大体时间: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 one 20cm step during six minute.
It will be evaluated by a pulse oxymeter.
|
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
大体时间:First day or second day of the protocol (random)
|
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.
|
First day or second day of the protocol (random)
|
Second "Six Minute Walk Test" Heart Rate
大体时间:First day or second day of the protocol (random), 30 minutes after the first 6MWT
|
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.
|
First day or second day of the protocol (random), 30 minutes after the first 6MWT
|
Third "Six Minute Walk Test" Heart Rate
大体时间: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.
|
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.
|
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
大体时间: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.
It will be evaluated by a cardio monitor.
|
First day or second day of the protocol (random)
|
Second "Six Minute Step Test" Heart Rate
大体时间:First day or second day of the protocol (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 minute.
It will be evaluated by a cardio monitor.
|
First day or second day of the protocol (random), 30 minutes after the first 6MST
|
Third "Six Minute Step Test" Heart Rate
大体时间: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 minute.
It will be evaluated by a cardio monitor.
|
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.
|
合作者和调查者
调查人员
- 研究主任:Valéria Amorim Pires Di Lorenzo, PhD、Universidade Federal de Sao Carlos
出版物和有用的链接
一般刊物
- Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- 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. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.