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Trial record 3 of 5 for:    6859656 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT01298661
Recruitment Status : Completed
First Posted : February 18, 2011
Results First Posted : September 13, 2013
Last Update Posted : November 26, 2013
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Valeria Amorim Pires Di Lorenzo, Universidade Federal de Sao Carlos

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Chronic Obstructive Pulmonary Disease
Intervention Other: Six-minute Step Test
Enrollment 91
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.
Pre-assignment Details  
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description Subjects apparently healthy, with age of 18 to 27 years old. Subjects apparently healthy, with age of 60 to 75 years old. Patients with clinical and spirometric diagnosis of COPD
Period Title: Overall Study
Started 33 24 34
Completed 31 24 32
Not Completed 2 0 2
Reason Not Completed
Withdrawal by Subject             2             0             2
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients Total
Hide Arm/Group Description Subjects apparently healthy, with age of 18 to 27 years old. Subjects apparently healthy, with age of 60 to 75 years old. Patients with clinical and spirometric diagnosis of COPD Total of all reporting groups
Overall Number of Baseline Participants 31 24 32 87
Hide Baseline Analysis Population Description
In the group of health young subjects there were a loss of 2 individuals who did not completed the evaluations. In the group of COPD patients there was a loss of 2 patients who did not completed the evaluations.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 24 participants 32 participants 87 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
31
 100.0%
6
  25.0%
9
  28.1%
46
  52.9%
>=65 years
0
   0.0%
18
  75.0%
23
  71.9%
41
  47.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 24 participants 32 participants 87 participants
22.7  (2.52) 68.9  (6.75) 68.6  (10.3) 52.3  (23.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 24 participants 32 participants 87 participants
Female
15
  48.4%
12
  50.0%
8
  25.0%
35
  40.2%
Male
16
  51.6%
12
  50.0%
24
  75.0%
52
  59.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 31 participants 24 participants 32 participants 87 participants
31 24 32 87
1.Primary Outcome
Title First "Six Minute Step Test" Performance
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 24 32
Mean (Standard Deviation)
Unit of Measure: steps
166.4  (36.4) 114.0  (29.2) 76.6  (19.6)
2.Primary Outcome
Title Second "Six Minute Step Test" Performance
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 24 32
Mean (Standard Deviation)
Unit of Measure: steps
170.7  (40.6) 114.5  (33.5) 82.4  (20.7)
3.Primary Outcome
Title Third "Six Minute Step Test" Performance
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 19 29
Mean (Standard Deviation)
Unit of Measure: steps
172.3  (36.3) 111.3  (32.9) 86.4  (22.0)
4.Secondary Outcome
Title First "Six Minute Walk Test" Distance
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 24 32
Mean (Standard Deviation)
Unit of Measure: meter
643.5  (63.1) 504.5  (119) 380.4  (107.8)
5.Secondary Outcome
Title Second "Six Minute Walk Test" Distance
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 24 32
Mean (Standard Deviation)
Unit of Measure: meter
648.2  (81.9) 513.6  (84.3) 391.0  (94.0)
6.Secondary Outcome
Title Third "Six Minute Walk Test" Distance
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 19 29
Mean (Standard Deviation)
Unit of Measure: meter
648.3  (73.9) 502  (112.4) 392.4  (93.0)
7.Secondary Outcome
Title "Body-Mass Index, Airflow Obstruction, Dyspnea, Exercise Capacity" Index (BODE Index)
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title COPD Patients
Hide Arm/Group Description:
Patients with clinical and spirometrical diagnosis of Chronic Obstructive Pulmonary Disease
Overall Number of Participants Analyzed 32
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
3
(1 to 4)
8.Secondary Outcome
Title First "Six Minute Walk Test" Exertion Perception
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 24 32
Median (Full Range)
Unit of Measure: units on a scale
1
(0 to 5)
0.5
(0 to 5)
1
(0 to 5)
9.Secondary Outcome
Title Second "Six Minute Walk Test" Exertion Perception
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 24 32
Median (Full Range)
Unit of Measure: units on a scale
0.5
(0 to 5)
0.5
(0 to 6)
1
(0 to 4)
10.Secondary Outcome
Title Third "Six Minute Walk Test" Exertion Perception
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 19 29
Median (Full Range)
Unit of Measure: units on a scale
1
(0 to 3)
1
(0 to 5)
2
(0 to 5)
11.Secondary Outcome
Title First "Six Minute Step Test" Exertion Perception
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 24 32
Median (Full Range)
Unit of Measure: units on a scale
2
(0 to 5)
2.5
(0 to 7)
2
(0 to 7)
12.Secondary Outcome
Title Second "Six Minute Step Test" Exertion Perception
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 24 32
Median (Full Range)
Unit of Measure: units on a scale
2
(0 to 7)
1.5
(0 to 6)
2.5
(0 to 7)
13.Secondary Outcome
Title Third "Six Minute Step Test" Exertion Perception
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 19 29
Median (Full Range)
Unit of Measure: units on a scale
1
(0 to 6)
2
(0 to 7)
2.5
(0 to 8)
14.Secondary Outcome
Title First "Six Minute Walk Test" Peripheral Oxygen Saturation
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 24 32
Mean (Standard Deviation)
Unit of Measure: % of hemoglobin
96.7  (1.3) 94.5  (1.7) 90.4  (3.15)
15.Secondary Outcome
Title Second "Six Minute Walk Test" Peripheral Oxygen Saturation
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 24 32
Mean (Standard Deviation)
Unit of Measure: % of hemoglobin
96.4  (1.81) 95.1  (1.48) 90.3  (3.33)
16.Secondary Outcome
Title Third "Six Minute Walk Test" Peripheral Oxygen Saturation
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 19 29
Mean (Standard Deviation)
Unit of Measure: % of hemoglobin
96.1  (1.6) 94.7  (2.0) 89.7  (3.3)
17.Secondary Outcome
Title First "Six Minute Step Test" Peripheral Oxygen Saturation
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 24 32
Mean (Standard Deviation)
Unit of Measure: % of hemoglobin
95.8  (1.3) 95  (1.9) 90.1  (3.9)
18.Secondary Outcome
Title Second "Six Minute Step Test" Peripheral Oxygen Saturation
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 24 32
Mean (Standard Deviation)
Unit of Measure: % of hemoglobin
96  (1.6) 94.9  (1.8) 90.5  (2.8)
19.Secondary Outcome
Title Third "Six Minute Step Test" Peripheral Oxygen Saturation
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 19 29
Mean (Standard Deviation)
Unit of Measure: % of hemoglobin
95.8  (1.3) 94.9  (1.8) 90.3  (3.1)
20.Secondary Outcome
Title First "Six Minute Walk Test" Heart Rate
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 24 32
Mean (Standard Deviation)
Unit of Measure: bpm
143  (15) 115  (11) 113  (11)
21.Secondary Outcome
Title Second "Six Minute Walk Test" Heart Rate
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 24 32
Mean (Standard Deviation)
Unit of Measure: bpm
144  (13) 115  (9) 112  (11)
22.Secondary Outcome
Title Third "Six Minute Walk Test" Heart Rate
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 19 29
Mean (Standard Deviation)
Unit of Measure: bpm
145  (10) 112  (13) 114  (13)
23.Secondary Outcome
Title First "Six Minute Step Test" Heart Rate
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 24 32
Mean (Standard Deviation)
Unit of Measure: bpm
154  (11) 116  (11) 117  (10)
24.Secondary Outcome
Title Second "Six Minute Step Test" Heart Rate
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 24 32
Mean (Standard Deviation)
Unit of Measure: bpm
159  (6.7) 118  (8.7) 117  (12)
25.Secondary Outcome
Title Third "Six Minute Step Test" Heart Rate
Hide Description 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description:
Subjects apparently healthy, with age of 18 to 27 years old.
Subjects apparently healthy, with age of 60 to 75 years old.
Patients with clinical and spirometric diagnosis of COPD
Overall Number of Participants Analyzed 31 19 29
Mean (Standard Deviation)
Unit of Measure: bpm
156  (11) 117  (9.3) 116  (15)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not assessed in this study.
 
Arm/Group Title Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Hide Arm/Group Description Subjects apparently healthy, with age of 18 to 27 years old. Subjects apparently healthy, with age of 60 to 75 years old. Patients with clinical and spirometric diagnosis of COPD
All-Cause Mortality
Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Young Subjects Healthy Elderly Subjects COPD Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
The enrolled patient's and subject's numbers were smaller than the estimated for healthy elders and different COPD groups, because of the low acceptance of a three days evaluation protocol. So COPD patients were analyzed in a single group.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Juliano Ferreira Arcuri
Organization: Universidade Federal de São Carlos
Phone: +55 (16) 33518343
Publications:
Responsible Party: Valeria Amorim Pires Di Lorenzo, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT01298661     History of Changes
Other Study ID Numbers: TD6reprod
First Submitted: February 17, 2011
First Posted: February 18, 2011
Results First Submitted: April 16, 2013
Results First Posted: September 13, 2013
Last Update Posted: November 26, 2013