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

Universidade Federal de Sao Carlos

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: Six-minute Step Test

Study type: Interventional

Funder types: Other

Identifiers

NCT01298661

TD6reprod

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 3 patient groups

Healthy Young Subjects

Other group

Description:

Subjects apparently healthy, with age of 18 to 27 years old.

Treatment:

Other: Six-minute Step Test

Healthy Elderly subjects

Other group

Description:

Subjects apparently healthy, with age of 60 to 75 years old.

Treatment:

Other: Six-minute Step Test

COPD Patients

Other group

Description:

Patients with clinical and spirometric diagnosis of COPD

Treatment:

Other: Six-minute Step Test