Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Exercise Test, Reproducibility of Results, Mortality
Brief 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.
Interventions
OTHERSix-minute Step Test
The patients underwent a test where they need to step up and down a 20cm test during six minutes.
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Universidade Federal de Sao Carlos
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Six Minute Step Test Performance | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body-Mass Index, Airflow Obstruction, Dyspnea, Exercise Capacity Index (BODE Index) | 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) |
| First Six Minute Walk Test Exertion Perception | 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. |
| Second Six Minute Walk Test Exertion Perception | 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. |
| 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. | 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. |
| First Six Minute Step Test Exertion Perception | 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. |
| Second Six Minute Step Test Exertion Perception | 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. |
| 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. | 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. |
| First Six Minute Walk Test Peripheral Oxygen Saturation | 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. |
| Second Six Minute Walk Test Peripheral Oxygen Saturation | ,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 Six Minute Walk Test Distance | 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 Six Minute Step Test Peripheral Oxygen Saturation | 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. |
| Second Six Minute Step Test Peripheral Oxygen Saturation | 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 . |
| 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. | 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. |
| First Six Minute Walk Test Heart Rate | 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. |
| Second Six Minute Walk Test Heart Rate | 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. |
| 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. | 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. |
| First Six Minute Step Test Heart Rate | 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. |
| Second Six Minute Step Test Heart Rate | 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. |
| 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. | 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. |
| 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. | 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. |
| Second Six Minute Walk Test Distance | 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. |
| 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. | 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. |
Countries
Brazil
Participant flow
Recruitment details
The recruitment occurred from February 2011 until July 2012. The COPD patients were those referred to pulmonary rehabilitation on Unidade Especial de Fisioterapia Respiratória and the health individuals were recruited by invitation using posters on the University region.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Young Subjects Subjects apparently healthy, with age of 18 to 27 years old. | 31 |
| Healthy Elderly Subjects Subjects apparently healthy, with age of 60 to 75 years old. | 24 |
| COPD Patients Patients with clinical and spirometric diagnosis of COPD | 32 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 | 2 |
Baseline characteristics
| Characteristic | Healthy Elderly Subjects | COPD Patients | Healthy Young Subjects | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 23 Participants | 0 Participants | 41 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 9 Participants | 31 Participants | 46 Participants |
| Age Continuous | 68.9 years STANDARD_DEVIATION 6.75 | 68.6 years STANDARD_DEVIATION 10.3 | 22.7 years STANDARD_DEVIATION 2.52 | 52.3 years STANDARD_DEVIATION 23.3 |
| Region of Enrollment Brazil | 24 participants | 32 participants | 31 participants | 87 participants |
| Sex: Female, Male Female | 12 Participants | 8 Participants | 15 Participants | 35 Participants |
| Sex: Female, Male Male | 12 Participants | 24 Participants | 16 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
First Six Minute Step Test Performance
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.
Time frame: First day or second day of the protocol (random)
Population: 2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Young Subjects | First Six Minute Step Test Performance | 166.4 steps | Standard Deviation 36.4 |
| Healthy Elderly Subjects | First Six Minute Step Test Performance | 114.0 steps | Standard Deviation 29.2 |
| COPD Patients | First Six Minute Step Test Performance | 76.6 steps | Standard Deviation 19.6 |
Primary
Second Six Minute Step Test Performance
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.
Time frame: On the first or second day of evaluation (random), 30 minutes after the first 6MST.
Population: 2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Young Subjects | Second Six Minute Step Test Performance | 170.7 steps | Standard Deviation 40.6 |
| Healthy Elderly Subjects | Second Six Minute Step Test Performance | 114.5 steps | Standard Deviation 33.5 |
| COPD Patients | Second Six Minute Step Test Performance | 82.4 steps | Standard Deviation 20.7 |
Primary
Third Six Minute Step Test Performance
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.
Time frame: 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.
Population: 2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Young Subjects | Third Six Minute Step Test Performance | 172.3 steps | Standard Deviation 36.3 |
| Healthy Elderly Subjects | Third Six Minute Step Test Performance | 111.3 steps | Standard Deviation 32.9 |
| COPD Patients | Third Six Minute Step Test Performance | 86.4 steps | Standard Deviation 22 |
Secondary
Body-Mass Index, Airflow Obstruction, Dyspnea, Exercise Capacity Index (BODE Index)
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)
Time frame: Second day
Population: 2 COPD were excluded since they did not appeared in the second day of evaluation. The other two populations were not verified, since the measure is specific for COPD patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Young Subjects | Body-Mass Index, Airflow Obstruction, Dyspnea, Exercise Capacity Index (BODE Index) | 3 units on a scale |
Secondary
First Six Minute Step Test Exertion Perception
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.
Time frame: First day or second day of the protocol (random)
Population: 2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Young Subjects | First Six Minute Step Test Exertion Perception | 2 units on a scale |
| Healthy Elderly Subjects | First Six Minute Step Test Exertion Perception | 2.5 units on a scale |
| COPD Patients | First Six Minute Step Test Exertion Perception | 2 units on a scale |
Secondary
First Six Minute Step Test Heart Rate
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.
Time frame: First day or second day of the protocol (random)
Population: 2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Young Subjects | First Six Minute Step Test Heart Rate | 154 bpm | Standard Deviation 11 |
| Healthy Elderly Subjects | First Six Minute Step Test Heart Rate | 116 bpm | Standard Deviation 11 |
| COPD Patients | First Six Minute Step Test Heart Rate | 117 bpm | Standard Deviation 10 |
Secondary
First Six Minute Step Test Peripheral Oxygen Saturation
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.
Time frame: First day or second day of the protocol (random)
Population: 2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Young Subjects | First Six Minute Step Test Peripheral Oxygen Saturation | 95.8 % of hemoglobin | Standard Deviation 1.3 |
| Healthy Elderly Subjects | First Six Minute Step Test Peripheral Oxygen Saturation | 95 % of hemoglobin | Standard Deviation 1.9 |
| COPD Patients | First Six Minute Step Test Peripheral Oxygen Saturation | 90.1 % of hemoglobin | Standard Deviation 3.9 |
Secondary
First Six Minute Walk Test Distance
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.
Time frame: First day or second day of the protocol (random)
Population: 2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Young Subjects | First Six Minute Walk Test Distance | 643.5 meter | Standard Deviation 63.1 |
| Healthy Elderly Subjects | First Six Minute Walk Test Distance | 504.5 meter | Standard Deviation 119 |
| COPD Patients | First Six Minute Walk Test Distance | 380.4 meter | Standard Deviation 107.8 |
Secondary
First Six Minute Walk Test Exertion Perception
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.
Time frame: First day or second day of the protocol (random)
Population: 2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Young Subjects | First Six Minute Walk Test Exertion Perception | 1 units on a scale |
| Healthy Elderly Subjects | First Six Minute Walk Test Exertion Perception | 0.5 units on a scale |
| COPD Patients | First Six Minute Walk Test Exertion Perception | 1 units on a scale |
Secondary
First Six Minute Walk Test Heart Rate
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.
Time frame: First day or second day of the protocol (random)
Population: 2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Young Subjects | First Six Minute Walk Test Heart Rate | 143 bpm | Standard Deviation 15 |
| Healthy Elderly Subjects | First Six Minute Walk Test Heart Rate | 115 bpm | Standard Deviation 11 |
| COPD Patients | First Six Minute Walk Test Heart Rate | 113 bpm | Standard Deviation 11 |
Secondary
First Six Minute Walk Test Peripheral Oxygen Saturation
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.
Time frame: First day or second day of the protocol (random)
Population: 2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Young Subjects | First Six Minute Walk Test Peripheral Oxygen Saturation | 96.7 % of hemoglobin | Standard Deviation 1.3 |
| Healthy Elderly Subjects | First Six Minute Walk Test Peripheral Oxygen Saturation | 94.5 % of hemoglobin | Standard Deviation 1.7 |
| COPD Patients | First Six Minute Walk Test Peripheral Oxygen Saturation | 90.4 % of hemoglobin | Standard Deviation 3.15 |
Secondary
Second Six Minute Step Test Exertion Perception
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.
Time frame: First day or second day of the protocol (random), 30 minutes after the first 6MST
Population: 2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Young Subjects | Second Six Minute Step Test Exertion Perception | 2 units on a scale |
| Healthy Elderly Subjects | Second Six Minute Step Test Exertion Perception | 1.5 units on a scale |
| COPD Patients | Second Six Minute Step Test Exertion Perception | 2.5 units on a scale |
Secondary
Second Six Minute Step Test Heart Rate
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.
Time frame: First day or second day of the protocol (random), 30 minutes after the first 6MST
Population: 2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Young Subjects | Second Six Minute Step Test Heart Rate | 159 bpm | Standard Deviation 6.7 |
| Healthy Elderly Subjects | Second Six Minute Step Test Heart Rate | 118 bpm | Standard Deviation 8.7 |
| COPD Patients | Second Six Minute Step Test Heart Rate | 117 bpm | Standard Deviation 12 |
Secondary
Second Six Minute Step Test Peripheral Oxygen Saturation
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 .
Time frame: First day or second day of the protocol (random) ,30 minutes after the first 6MST
Population: 2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Young Subjects | Second Six Minute Step Test Peripheral Oxygen Saturation | 96 % of hemoglobin | Standard Deviation 1.6 |
| Healthy Elderly Subjects | Second Six Minute Step Test Peripheral Oxygen Saturation | 94.9 % of hemoglobin | Standard Deviation 1.8 |
| COPD Patients | Second Six Minute Step Test Peripheral Oxygen Saturation | 90.5 % of hemoglobin | Standard Deviation 2.8 |
Secondary
Second Six Minute Walk Test Distance
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.
Time frame: On the first or second day of evaluation (random), 30 minutes after the first 6MWT.
Population: 2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Young Subjects | Second Six Minute Walk Test Distance | 648.2 meter | Standard Deviation 81.9 |
| Healthy Elderly Subjects | Second Six Minute Walk Test Distance | 513.6 meter | Standard Deviation 84.3 |
| COPD Patients | Second Six Minute Walk Test Distance | 391.0 meter | Standard Deviation 94 |
Secondary
Second Six Minute Walk Test Exertion Perception
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.
Time frame: First day or second day of the protocol (random), 30 minutes after the first 6MWT
Population: 2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Young Subjects | Second Six Minute Walk Test Exertion Perception | 0.5 units on a scale |
| Healthy Elderly Subjects | Second Six Minute Walk Test Exertion Perception | 0.5 units on a scale |
| COPD Patients | Second Six Minute Walk Test Exertion Perception | 1 units on a scale |
Secondary
Second Six Minute Walk Test Heart Rate
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.
Time frame: First day or second day of the protocol (random), 30 minutes after the first 6MWT
Population: 2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Young Subjects | Second Six Minute Walk Test Heart Rate | 144 bpm | Standard Deviation 13 |
| Healthy Elderly Subjects | Second Six Minute Walk Test Heart Rate | 115 bpm | Standard Deviation 9 |
| COPD Patients | Second Six Minute Walk Test Heart Rate | 112 bpm | Standard Deviation 11 |
Secondary
Second Six Minute Walk Test Peripheral Oxygen Saturation
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.
Time frame: ,First day or second day of the protocol (random) 30 minutes after the first 6MWT
Population: 2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Young Subjects | Second Six Minute Walk Test Peripheral Oxygen Saturation | 96.4 % of hemoglobin | Standard Deviation 1.81 |
| Healthy Elderly Subjects | Second Six Minute Walk Test Peripheral Oxygen Saturation | 95.1 % of hemoglobin | Standard Deviation 1.48 |
| COPD Patients | Second Six Minute Walk Test Peripheral Oxygen Saturation | 90.3 % of hemoglobin | Standard Deviation 3.33 |
Secondary
Third Six Minute Step Test Exertion Perception
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.
Time frame: 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.
Population: 2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Young Subjects | Third Six Minute Step Test Exertion Perception | 1 units on a scale |
| Healthy Elderly Subjects | Third Six Minute Step Test Exertion Perception | 2 units on a scale |
| COPD Patients | Third Six Minute Step Test Exertion Perception | 2.5 units on a scale |
Secondary
Third Six Minute Step Test Heart Rate
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.
Time frame: 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.
Population: 2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Young Subjects | Third Six Minute Step Test Heart Rate | 156 bpm | Standard Deviation 11 |
| Healthy Elderly Subjects | Third Six Minute Step Test Heart Rate | 117 bpm | Standard Deviation 9.3 |
| COPD Patients | Third Six Minute Step Test Heart Rate | 116 bpm | Standard Deviation 15 |
Secondary
Third Six Minute Step Test Peripheral Oxygen Saturation
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.
Time frame: 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.
Population: 2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Young Subjects | Third Six Minute Step Test Peripheral Oxygen Saturation | 95.8 % of hemoglobin | Standard Deviation 1.3 |
| Healthy Elderly Subjects | Third Six Minute Step Test Peripheral Oxygen Saturation | 94.9 % of hemoglobin | Standard Deviation 1.8 |
| COPD Patients | Third Six Minute Step Test Peripheral Oxygen Saturation | 90.3 % of hemoglobin | Standard Deviation 3.1 |
Secondary
Third Six Minute Walk Test Distance
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.
Time frame: 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.
Population: 2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Young Subjects | Third Six Minute Walk Test Distance | 648.3 meter | Standard Deviation 73.9 |
| Healthy Elderly Subjects | Third Six Minute Walk Test Distance | 502 meter | Standard Deviation 112.4 |
| COPD Patients | Third Six Minute Walk Test Distance | 392.4 meter | Standard Deviation 93 |
Secondary
Third Six Minute Walk Test Exertion Perception
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.
Time frame: 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.
Population: 2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Young Subjects | Third Six Minute Walk Test Exertion Perception | 1 units on a scale |
| Healthy Elderly Subjects | Third Six Minute Walk Test Exertion Perception | 1 units on a scale |
| COPD Patients | Third Six Minute Walk Test Exertion Perception | 2 units on a scale |
Secondary
Third Six Minute Walk Test Heart Rate
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.
Time frame: 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.
Population: 2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Young Subjects | Third Six Minute Walk Test Heart Rate | 145 bpm | Standard Deviation 10 |
| Healthy Elderly Subjects | Third Six Minute Walk Test Heart Rate | 112 bpm | Standard Deviation 13 |
| COPD Patients | Third Six Minute Walk Test Heart Rate | 114 bpm | Standard Deviation 13 |
Secondary
Third Six Minute Walk Test Peripheral Oxygen Saturation
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.
Time frame: 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.
Population: 2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Young Subjects | Third Six Minute Walk Test Peripheral Oxygen Saturation | 96.1 % of hemoglobin | Standard Deviation 1.6 |
| Healthy Elderly Subjects | Third Six Minute Walk Test Peripheral Oxygen Saturation | 94.7 % of hemoglobin | Standard Deviation 2 |
| COPD Patients | Third Six Minute Walk Test Peripheral Oxygen Saturation | 89.7 % of hemoglobin | Standard Deviation 3.3 |