Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

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

31 октября 2013 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

91

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 75 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Диагностика
  • Распределение: Нерандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Другой: 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.
Другие имена:
  • Exercise Test
Другой: 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.
Другие имена:
  • Exercise Test
Другой: 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.
Другие имена:
  • Exercise Test

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
First "Six Minute Step Test" Performance
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
First "Six Minute Walk Test" Distance
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: ,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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Следователи

  • Директор по исследованиям: Valéria Amorim Pires Di Lorenzo, PhD, Universidade Federal de São Carlos

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 февраля 2011 г.

Первичное завершение (Действительный)

1 декабря 2012 г.

Завершение исследования (Действительный)

1 декабря 2012 г.

Даты регистрации исследования

Первый отправленный

17 февраля 2011 г.

Впервые представлено, что соответствует критериям контроля качества

17 февраля 2011 г.

Первый опубликованный (Оценивать)

18 февраля 2011 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

26 ноября 2013 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

31 октября 2013 г.

Последняя проверка

1 сентября 2013 г.

Дополнительная информация

Термины, связанные с этим исследованием

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Подписаться