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

31. Oktober 2013 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

91

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: 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.
Andere Namen:
  • Exercise Test
Sonstiges: 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.
Andere Namen:
  • Exercise Test
Sonstiges: 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.
Andere Namen:
  • Exercise Test

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
First "Six Minute Step Test" Performance
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
First "Six Minute Walk Test" Distance
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: ,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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Studienleiter: Valéria Amorim Pires Di Lorenzo, PhD, Universidade Federal de São Carlos

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Februar 2011

Primärer Abschluss (Tatsächlich)

1. Dezember 2012

Studienabschluss (Tatsächlich)

1. Dezember 2012

Studienanmeldedaten

Zuerst eingereicht

17. Februar 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Februar 2011

Zuerst gepostet (Schätzen)

18. Februar 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

26. November 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. Oktober 2013

Zuletzt verifiziert

1. September 2013

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

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