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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Healthy Young Subjects   Healthy Elderly Subjects   COPD Patients
STARTED   33   24   34 
COMPLETED   31   24   32 
NOT COMPLETED   2   0   2 
Withdrawal by Subject                2                0                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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.


Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   Healthy Young Subjects   Healthy Elderly Subjects   COPD Patients   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   24   32   87 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   31   6   9   46 
>=65 years   0   18   23   41 
Age 
[Units: Years]
Mean (Standard Deviation)
 22.7  (2.52)   68.9  (6.75)   68.6  (10.3)   52.3  (23.3) 
Gender 
[Units: Participants]
       
Female   15   12   8   35 
Male   16   12   24   52 
Region of Enrollment 
[Units: Participants]
       
Brazil   31   24   32   87 


  Outcome Measures

1.  Primary:   First "Six Minute Step Test" Performance   [ Time Frame: First day or second day of the protocol (random) ]

2.  Primary:   Second "Six Minute Step Test" Performance   [ Time Frame: On the first or second day of evaluation (random), 30 minutes after the first 6MST. ]

3.  Primary:   Third "Six Minute Step Test" Performance   [ 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. ]

4.  Secondary:   First "Six Minute Walk Test" Distance   [ Time Frame: First day or second day of the protocol (random) ]

5.  Secondary:   Second "Six Minute Walk Test" Distance   [ Time Frame: On the first or second day of evaluation (random), 30 minutes after the first 6MWT. ]

6.  Secondary:   Third "Six Minute Walk Test" Distance   [ 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. ]

7.  Secondary:   "Body-Mass Index, Airflow Obstruction, Dyspnea, Exercise Capacity" Index (BODE Index)   [ Time Frame: Second day ]

8.  Secondary:   First "Six Minute Walk Test" Exertion Perception   [ Time Frame: First day or second day of the protocol (random) ]

9.  Secondary:   Second "Six Minute Walk Test" Exertion Perception   [ Time Frame: First day or second day of the protocol (random), 30 minutes after the first 6MWT ]

10.  Secondary:   Third "Six Minute Walk Test" Exertion Perception   [ 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. ]

11.  Secondary:   First "Six Minute Step Test" Exertion Perception   [ Time Frame: First day or second day of the protocol (random) ]

12.  Secondary:   Second "Six Minute Step Test" Exertion Perception   [ Time Frame: First day or second day of the protocol (random), 30 minutes after the first 6MST ]

13.  Secondary:   Third "Six Minute Step Test" Exertion Perception   [ 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. ]

14.  Secondary:   First "Six Minute Walk Test" Peripheral Oxygen Saturation   [ Time Frame: First day or second day of the protocol (random) ]

15.  Secondary:   Second "Six Minute Walk Test" Peripheral Oxygen Saturation   [ Time Frame: ,First day or second day of the protocol (random) 30 minutes after the first 6MWT ]

16.  Secondary:   Third "Six Minute Walk Test" Peripheral Oxygen Saturation   [ 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. ]

17.  Secondary:   First "Six Minute Step Test" Peripheral Oxygen Saturation   [ Time Frame: First day or second day of the protocol (random) ]

18.  Secondary:   Second "Six Minute Step Test" Peripheral Oxygen Saturation   [ Time Frame: First day or second day of the protocol (random) ,30 minutes after the first 6MST ]

19.  Secondary:   Third "Six Minute Step Test" Peripheral Oxygen Saturation   [ 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. ]

20.  Secondary:   First "Six Minute Walk Test" Heart Rate   [ Time Frame: First day or second day of the protocol (random) ]

21.  Secondary:   Second "Six Minute Walk Test" Heart Rate   [ Time Frame: First day or second day of the protocol (random), 30 minutes after the first 6MWT ]

22.  Secondary:   Third "Six Minute Walk Test" Heart Rate   [ 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. ]

23.  Secondary:   First "Six Minute Step Test" Heart Rate   [ Time Frame: First day or second day of the protocol (random) ]

24.  Secondary:   Second "Six Minute Step Test" Heart Rate   [ Time Frame: First day or second day of the protocol (random), 30 minutes after the first 6MST ]

25.  Secondary:   Third "Six Minute Step Test" Heart Rate   [ 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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: julianoarcuri@gmail.com


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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