N/A
Completed N=91
Reliability, Sensitivity and Validity of the 6 Minute Step Test in Chronic Obstructive Pulmonary Disease (COPD) Patients
Source: ClinicalTrials.gov NCT01298661 ↗Enrolled (actual)
91
Serious AEs
—
Results posted
Sep 2013
Primary outcomePrimary: First "Six Minute Step Test" Performance — 166.4; 114.0; 76.6 steps
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY First "Six Minute Step Test" Performance |
166.4; 114.0; 76.6 | — |
| PRIMARY Second "Six Minute Step Test" Performance |
170.7; 114.5; 82.4 | — |
| PRIMARY Third "Six Minute Step Test" Performance |
172.3; 111.3; 86.4 | — |
| SECONDARY First "Six Minute Walk Test" Distance |
643.5; 504.5; 380.4 | — |
| SECONDARY Second "Six Minute Walk Test" Distance |
648.2; 513.6; 391.0 | — |
| SECONDARY Third "Six Minute Walk Test" Distance |
648.3; 502; 392.4 | — |
| SECONDARY "Body-Mass Index, Airflow Obstruction, Dyspnea, Exercise Capacity" Index (BODE Index) |
3 | — |
| SECONDARY First "Six Minute Walk Test" Exertion Perception |
1; 0.5; 1 | — |
| SECONDARY Second "Six Minute Walk Test" Exertion Perception |
0.5; 0.5; 1 | — |
| SECONDARY Third "Six Minute Walk Test" Exertion Perception |
1; 1; 2 | — |
| SECONDARY First "Six Minute Step Test" Exertion Perception |
2; 2.5; 2 | — |
| SECONDARY Second "Six Minute Step Test" Exertion Perception |
2; 1.5; 2.5 | — |
| SECONDARY Third "Six Minute Step Test" Exertion Perception |
1; 2; 2.5 | — |
| SECONDARY First "Six Minute Walk Test" Peripheral Oxygen Saturation |
96.7; 94.5; 90.4 | — |
| SECONDARY Second "Six Minute Walk Test" Peripheral Oxygen Saturation |
96.4; 95.1; 90.3 | — |
| SECONDARY Third "Six Minute Walk Test" Peripheral Oxygen Saturation |
96.1; 94.7; 89.7 | — |
| SECONDARY First "Six Minute Step Test" Peripheral Oxygen Saturation |
95.8; 95; 90.1 | — |
| SECONDARY Second "Six Minute Step Test" Peripheral Oxygen Saturation |
96; 94.9; 90.5 | — |
| SECONDARY Third "Six Minute Step Test" Peripheral Oxygen Saturation |
95.8; 94.9; 90.3 | — |
| SECONDARY First "Six Minute Walk Test" Heart Rate |
143; 115; 113 | — |
| SECONDARY Second "Six Minute Walk Test" Heart Rate |
144; 115; 112 | — |
| SECONDARY Third "Six Minute Walk Test" Heart Rate |
145; 112; 114 | — |
| SECONDARY First "Six Minute Step Test" Heart Rate |
154; 116; 117 | — |
| SECONDARY Second "Six Minute Step Test" Heart Rate |
159; 118; 117 | — |
| SECONDARY Third "Six Minute Step Test" Heart Rate |
156; 117; 116 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01298661). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.