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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- First "Six Minute Step Test" Performance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young and elderly healthy subjects presented pulmonary function within the normal range, confirmed by spirometry
- •Patients with clinical and spirometric diagnosis of COPD
排除标准
- •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
结局指标
主要结局
First "Six Minute Step Test" Performance
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Third "Six Minute Walk Test" Distance(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 Walk Test" Exertion Perception(First day or second day of the protocol (random))
- Third "Six Minute Walk Test" Heart Rate(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.)
- Second "Six Minute Walk Test" Distance(On the first or second day of evaluation (random), 30 minutes after the first 6MWT.)
- First "Six Minute Walk Test" Distance(First day or second day of the protocol (random))
- "Body-Mass Index, Airflow Obstruction, Dyspnea, Exercise Capacity" Index (BODE Index)(Second day)
- Second "Six Minute Walk Test" Exertion Perception(First day or second day of the protocol (random), 30 minutes after the first 6MWT)
- Third "Six Minute Walk Test" Exertion Perception(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(First day or second day of the protocol (random))
- Second "Six Minute Step Test" Exertion Perception(First day or second day of the protocol (random), 30 minutes after the first 6MST)
- First "Six Minute Walk Test" Peripheral Oxygen Saturation(First day or second day of the protocol (random))
- Second "Six Minute Walk Test" Peripheral Oxygen Saturation(,First day or second day of the protocol (random) 30 minutes after the first 6MWT)
- Third "Six Minute Walk Test" Peripheral Oxygen Saturation(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(First day or second day of the protocol (random))
- Second "Six Minute Step Test" Peripheral Oxygen Saturation(First day or second day of the protocol (random) ,30 minutes after the first 6MST)
- Third "Six Minute Step Test" Peripheral Oxygen Saturation(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(First day or second day of the protocol (random))
- Second "Six Minute Walk Test" Heart Rate(First day or second day of the protocol (random), 30 minutes after the first 6MWT)
- First "Six Minute Step Test" Heart Rate(First day or second day of the protocol (random))
- Second "Six Minute Step Test" Heart Rate(First day or second day of the protocol (random), 30 minutes after the first 6MST)
- Third "Six Minute Step Test" Exertion Perception(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.)
- Third "Six Minute Step Test" Heart Rate(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.)
研究者
Valeria Amorim Pires Di Lorenzo
PhD
Universidade Federal de Sao Carlos