Reliability, Sensitivity and Validity of the 6 Minute Step Test in Chronic Obstructive Pulmonary Disease (COPD) Patients
2013年10月31日 更新者：Valeria Amorim Pires Di Lorenzo、Universidade Federal de Sao Carlos
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.
調査の概要
研究の種類
介入
入学 (実際)
91
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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São Paulo
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São Carlos、São Paulo、ブラジル、13561-206
- Unidade Especial de Fisioterapia Respiratória
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～75年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：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.
他の名前：
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他の：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.
他の名前：
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他の：COPD Patients
Patients with clinical and spirometric diagnosis of COPD
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The patients underwent a test where they need to step up and down a 20cm test during six minutes.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
First "Six Minute Step Test" Performance
時間枠：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
時間枠：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
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
First "Six Minute Walk Test" Distance
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
|
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First "Six Minute Walk Test" Exertion Perception
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：,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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Valéria Amorim Pires Di Lorenzo, PhD、Universidade Federal de Sao Carlos
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- 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.
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- 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.
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- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年2月1日
一次修了 (実際)
2012年12月1日
研究の完了 (実際)
2012年12月1日
試験登録日
最初に提出
2011年2月17日
QC基準を満たした最初の提出物
2011年2月17日
最初の投稿 (見積もり)
2011年2月18日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年11月26日
QC基準を満たした最後の更新が送信されました
2013年10月31日
最終確認日
2013年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Six-minute Step Testの臨床試験
-
National Taiwan University Hospital完了