Trial Outcomes & Findings for Reliability, Sensitivity and Validity of the 6 Minute Step Test in Chronic Obstructive Pulmonary Disease (COPD) Patients (NCT NCT01298661)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

91 participants

Primary outcome timeframe

First day or second day of the protocol (random)

Results posted on

2013-11-26

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Healthy Young Subjects Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects Subjects apparently healthy, with age of 60 to 75 years old.	COPD Patients Patients with clinical and spirometric diagnosis of COPD
Overall Study STARTED	33	24	34
Overall Study COMPLETED	31	24	32
Overall Study NOT COMPLETED	2	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Young Subjects Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects Subjects apparently healthy, with age of 60 to 75 years old.	COPD Patients Patients with clinical and spirometric diagnosis of COPD
Overall Study Withdrawal by Subject	2	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=24 Participants Subjects apparently healthy, with age of 60 to 75 years old.	COPD Patients n=32 Participants Patients with clinical and spirometric diagnosis of COPD	Total n=87 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=39 Participants	6 Participants n=41 Participants	9 Participants n=35 Participants	46 Participants n=31 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	18 Participants n=41 Participants	23 Participants n=35 Participants	41 Participants n=31 Participants
Age Continuous	22.7 years STANDARD_DEVIATION 2.52 • n=39 Participants	68.9 years STANDARD_DEVIATION 6.75 • n=41 Participants	68.6 years STANDARD_DEVIATION 10.3 • n=35 Participants	52.3 years STANDARD_DEVIATION 23.3 • n=31 Participants
Sex: Female, Male Female	15 Participants n=39 Participants	12 Participants n=41 Participants	8 Participants n=35 Participants	35 Participants n=31 Participants
Sex: Female, Male Male	16 Participants n=39 Participants	12 Participants n=41 Participants	24 Participants n=35 Participants	52 Participants n=31 Participants
Region of Enrollment Brazil	31 participants n=39 Participants	24 participants n=41 Participants	32 participants n=35 Participants	87 participants n=31 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=32 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=24 Participants Subjects apparently healthy, with age of 60 to 75 years old.
First "Six Minute Step Test" Performance	76.6 steps Standard Deviation 19.6	166.4 steps Standard Deviation 36.4	114.0 steps Standard Deviation 29.2

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=32 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=24 Participants Subjects apparently healthy, with age of 60 to 75 years old.
Second "Six Minute Step Test" Performance	82.4 steps Standard Deviation 20.7	170.7 steps Standard Deviation 40.6	114.5 steps Standard Deviation 33.5

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=29 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=19 Participants Subjects apparently healthy, with age of 60 to 75 years old.
Third "Six Minute Step Test" Performance	86.4 steps Standard Deviation 22.0	172.3 steps Standard Deviation 36.3	111.3 steps Standard Deviation 32.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=32 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=24 Participants Subjects apparently healthy, with age of 60 to 75 years old.
First "Six Minute Walk Test" Distance	380.4 meter Standard Deviation 107.8	643.5 meter Standard Deviation 63.1	504.5 meter Standard Deviation 119

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=32 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=24 Participants Subjects apparently healthy, with age of 60 to 75 years old.
Second "Six Minute Walk Test" Distance	391.0 meter Standard Deviation 94.0	648.2 meter Standard Deviation 81.9	513.6 meter Standard Deviation 84.3

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=29 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=19 Participants Subjects apparently healthy, with age of 60 to 75 years old.
Third "Six Minute Walk Test" Distance	392.4 meter Standard Deviation 93.0	648.3 meter Standard Deviation 73.9	502 meter Standard Deviation 112.4

SECONDARY outcome

Timeframe: 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

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)

Outcome measures

Outcome measures
Measure	COPD Patients Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=32 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects Subjects apparently healthy, with age of 60 to 75 years old.
"Body-Mass Index, Airflow Obstruction, Dyspnea, Exercise Capacity" Index (BODE Index)	—	3 units on a scale Interval 1.0 to 4.0	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=32 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=24 Participants Subjects apparently healthy, with age of 60 to 75 years old.
First "Six Minute Walk Test" Exertion Perception	1 units on a scale Interval 0.0 to 5.0	1 units on a scale Interval 0.0 to 5.0	0.5 units on a scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=32 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=24 Participants Subjects apparently healthy, with age of 60 to 75 years old.
Second "Six Minute Walk Test" Exertion Perception	1 units on a scale Interval 0.0 to 4.0	0.5 units on a scale Interval 0.0 to 5.0	0.5 units on a scale Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=29 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=19 Participants Subjects apparently healthy, with age of 60 to 75 years old.
Third "Six Minute Walk Test" Exertion Perception	2 units on a scale Interval 0.0 to 5.0	1 units on a scale Interval 0.0 to 3.0	1 units on a scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=32 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=24 Participants Subjects apparently healthy, with age of 60 to 75 years old.
First "Six Minute Step Test" Exertion Perception	2 units on a scale Interval 0.0 to 7.0	2 units on a scale Interval 0.0 to 5.0	2.5 units on a scale Interval 0.0 to 7.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=32 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=24 Participants Subjects apparently healthy, with age of 60 to 75 years old.
Second "Six Minute Step Test" Exertion Perception	2.5 units on a scale Interval 0.0 to 7.0	2 units on a scale Interval 0.0 to 7.0	1.5 units on a scale Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=29 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=19 Participants Subjects apparently healthy, with age of 60 to 75 years old.
Third "Six Minute Step Test" Exertion Perception	2.5 units on a scale Interval 0.0 to 8.0	1 units on a scale Interval 0.0 to 6.0	2 units on a scale Interval 0.0 to 7.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=32 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=24 Participants Subjects apparently healthy, with age of 60 to 75 years old.
First "Six Minute Walk Test" Peripheral Oxygen Saturation	90.4 % of hemoglobin Standard Deviation 3.15	96.7 % of hemoglobin Standard Deviation 1.3	94.5 % of hemoglobin Standard Deviation 1.7

SECONDARY outcome

Timeframe: ,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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=32 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=24 Participants Subjects apparently healthy, with age of 60 to 75 years old.
Second "Six Minute Walk Test" Peripheral Oxygen Saturation	90.3 % of hemoglobin Standard Deviation 3.33	96.4 % of hemoglobin Standard Deviation 1.81	95.1 % of hemoglobin Standard Deviation 1.48

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=29 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=19 Participants Subjects apparently healthy, with age of 60 to 75 years old.
Third "Six Minute Walk Test" Peripheral Oxygen Saturation	89.7 % of hemoglobin Standard Deviation 3.3	96.1 % of hemoglobin Standard Deviation 1.6	94.7 % of hemoglobin Standard Deviation 2.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=32 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=24 Participants Subjects apparently healthy, with age of 60 to 75 years old.
First "Six Minute Step Test" Peripheral Oxygen Saturation	90.1 % of hemoglobin Standard Deviation 3.9	95.8 % of hemoglobin Standard Deviation 1.3	95 % of hemoglobin Standard Deviation 1.9

SECONDARY outcome

Timeframe: 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.

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 .

Outcome measures

Outcome measures
Measure	COPD Patients n=32 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=24 Participants Subjects apparently healthy, with age of 60 to 75 years old.
Second "Six Minute Step Test" Peripheral Oxygen Saturation	90.5 % of hemoglobin Standard Deviation 2.8	96 % of hemoglobin Standard Deviation 1.6	94.9 % of hemoglobin Standard Deviation 1.8

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=29 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=19 Participants Subjects apparently healthy, with age of 60 to 75 years old.
Third "Six Minute Step Test" Peripheral Oxygen Saturation	90.3 % of hemoglobin Standard Deviation 3.1	95.8 % of hemoglobin Standard Deviation 1.3	94.9 % of hemoglobin Standard Deviation 1.8

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=32 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=24 Participants Subjects apparently healthy, with age of 60 to 75 years old.
First "Six Minute Walk Test" Heart Rate	113 bpm Standard Deviation 11	143 bpm Standard Deviation 15	115 bpm Standard Deviation 11

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=32 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=24 Participants Subjects apparently healthy, with age of 60 to 75 years old.
Second "Six Minute Walk Test" Heart Rate	112 bpm Standard Deviation 11	144 bpm Standard Deviation 13	115 bpm Standard Deviation 9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=29 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=19 Participants Subjects apparently healthy, with age of 60 to 75 years old.
Third "Six Minute Walk Test" Heart Rate	114 bpm Standard Deviation 13	145 bpm Standard Deviation 10	112 bpm Standard Deviation 13

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=32 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=24 Participants Subjects apparently healthy, with age of 60 to 75 years old.
First "Six Minute Step Test" Heart Rate	117 bpm Standard Deviation 10	154 bpm Standard Deviation 11	116 bpm Standard Deviation 11

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=32 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=24 Participants Subjects apparently healthy, with age of 60 to 75 years old.
Second "Six Minute Step Test" Heart Rate	117 bpm Standard Deviation 12	159 bpm Standard Deviation 6.7	118 bpm Standard Deviation 8.7

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	COPD Patients n=29 Participants Patients with clinical and spirometric diagnosis of COPD	Healthy Young Subjects n=31 Participants Subjects apparently healthy, with age of 18 to 27 years old.	Healthy Elderly Subjects n=19 Participants Subjects apparently healthy, with age of 60 to 75 years old.
Third "Six Minute Step Test" Heart Rate	116 bpm Standard Deviation 15	156 bpm Standard Deviation 11	117 bpm Standard Deviation 9.3

Adverse Events

Healthy Young Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Elderly Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

COPD Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Juliano Ferreira Arcuri

Universidade Federal de São Carlos

Phone: +55 (16) 33518343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place