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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Universidade Federal de Sao Carlos.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier:
NCT01298661
First received: February 17, 2011
Last updated: March 18, 2011
Last verified: March 2011

February 17, 2011
March 18, 2011
February 2011
July 2012   (final data collection date for primary outcome measure)
  • First "Six Minute Step Test" Performance [ Time Frame: First day of the protocol or the day after, by sortition ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 1", the patient will climb and down one 20cm step during six minute. The performance will be evaluated by the number of the climbs.
  • Second "Six Minute Step Test" Performance [ Time Frame: 30 minutes after the first 6MST ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 1", the patient will climb and down one 20cm step during six minutes. The performance will be evaluated by the number of the climbs.
  • Third "Six Minute Step Test" Performance [ Time Frame: Seven days after the first test, or 30 minutes after the third 6MST, by sortition ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 2", the patient will climb and down one 20cm step during six minutes. The performance will be evaluated by the number of the climbs.
Same as current
Complete list of historical versions of study NCT01298661 on ClinicalTrials.gov Archive Site
  • First "Six Minute Walk Test" Distance [ Time Frame: First day of the protocol or the day after, by sortition ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 1", the subject will walk as fast as it could in a 30m corridor during 6 minutes. The performance will be the distance (meters)that it walk.
  • Second "Six Minute Walk Test" Distance [ Time Frame: 30 minutes after the first 6MWT ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 1", the subject will walk as fast as it could in a 30m corridor during 6 minutes. The performance will be the distance (meters)that it walk.
  • Third "Six Minute Walk Test" Distance [ Time Frame: Seven days after the first test or 30 minutes after the Third 6MWT, by sortition ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 2", the subject will walk as fast as it could in a 30m corridor during 6 minutes. The performance will be the distance (meters)that it walk.
  • "Body-Mass index, Airflow Obstruction, Dyspnea, Exercise Capacity" Index (BODE index) [ Time Frame: First day of the protocol, after the tests ] [ Designated as safety issue: No ]
    It will be evaluated only in the COPD patients (Groups III, IV and V).
  • First "Six Minute Walk Test" exertion perception [ Time Frame: First day of the protocol or the day after, by sortition ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 1", the subject will walk as fast as it could in a 30m corridor during 6 minutes. The Exertion Perception will be evaluated by the CR10 BORG scale, at rest and every two minutes of the test.
  • Second "Six Minute Walk Test" exertion perception [ Time Frame: 30 minutes after the first 6MWT ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 1", the subject will walk as fast as it could in a 30m corridor during 6 minutes. The Exertion Perception will be evaluated by the CR10 BORG scale, at rest and every two minutes of the test.
  • Third "Six Minute Walk Test" Exertion Perception [ Time Frame: Seven days after the first test or 30 minutes after the Third 6MWT, by sortition ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 2", the subject will walk as fast as it could in a 30m corridor during 6 minutes. The Exertion Perception will be evaluated by the CR10 BORG scale, at rest and every two minutes of the test.
  • First "Six Minute Step Test" Exertion Perception [ Time Frame: First day of the protocol or the day after, by sortition ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 1", the patient will climb and down one 20cm step during six minute. The Exertion Perception will be evaluated by the CR10 BORG scale, at rest and every two minutes of the test.
  • Second "Six Minute Step Test" Exertion Perception [ Time Frame: 30 minutes after the first 6MST ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 1", the patient will climb and down one 20cm step during six minute. The Exertion Perception will be evaluated by the CR10 BORG scale, at rest and every two minutes of the test.
  • Third "Six Minute Step Test" Exertion Perception [ Time Frame: Seven days after the first test, or 30 minutes after the third 6MST, by sortition ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 2", the patient will climb and down one 20cm step during six minute. The Exertion Perception will be evaluated by the CR10 BORG scale, at rest and every two minutes of the test.
  • First "Six Minute Walk Test" Peripheral Oxygen Saturation [ Time Frame: First day of the protocol or the day after, by sortition ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 1", the subject will walk as fast as it could in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter at rest and every two minutes of the test.
  • Second "Six Minute Walk Test" Peripheral Oxygen Saturation [ Time Frame: 30 minutes after the first 6MWT ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 1", the subject will walk as fast as it could in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter at rest and every two minutes of the test.
  • Third "Six Minute Walk Test" Peripheral Oxygen Saturation [ Time Frame: Seven days after the first test or 30 minutes after the Third 6MWT, by sortition ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 2", the subject will walk as fast as it could in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter at rest and every two minutes of the test.
  • First "Six Minute Step Test" Peripheral Oxygen Saturation [ Time Frame: First day of the protocol or the day after, by sortition ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 1", the patient will climb and down one 20cm step during six minute. It will be evaluated by a pulse oxymeter at rest and every two minutes of the test.
  • Second "Six Minute Step Test" Peripheral Oxygen Saturation [ Time Frame: 30 minutes after the first 6MST ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 1", the patient will climb and down one 20cm step during six minute. It will be evaluated by a pulse oxymeter at rest and every two minutes of the test.
  • Third "Six Minute Step Test" Peripheral Oxygen Saturation [ Time Frame: Seven days after the first test or 30 minutes after the Third 6MST, by sortition ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 2", the patient will climb and down one 20cm step during six minute. It will be evaluated by a pulse oxymeter at rest and every two minutes of the test.
  • First "Six Minute Walk Test" Variation in Heart Rate [ Time Frame: First day of the protocol or the day after, by sortition ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 1", the subject will walk as fast as it could in a 30m corridor during 6 minutes. It will be evaluated by a cardio monitor at rest and every two minutes of the test.
  • Second "Six Minute Walk Test" Variation in Heart Rate [ Time Frame: 30 minutes after the first 6MWT ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 1", the subject will walk as fast as it could 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" Variation in Heart Rate [ Time Frame: Seven days after the first test or 30 minutes after the Third 6MWT, by sortition ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 2", the subject will walk as fast as it could in a 30m corridor during 6 minutes. It will be evaluated by a cardio monitor at rest and every two minutes of the test.
  • First "Six Minute Step Test" Variation in Heart Rate [ Time Frame: First day of the protocol or the day after, by sortition ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 1", the patient will climb and down one 20cm step during six minute. It will be evaluated by a cardio monitor at rest and every two minutes of the test.
  • Second "Six Minute Step Test" Variation in Heart Rate [ Time Frame: 30 minutes after the first 6MST ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 1", the patient will climb and down one 20cm step during six minute. It will be evaluated by a cardio monitor at rest and every two minutes of the test.
  • Third "Six Minute Step Test" Variation in Heart Rate Variation [ Time Frame: Seven days after the first test or 30 minutes after the Third 6MST, by sortition ] [ Designated as safety issue: No ]
    This test will be conducted by the "Rater 2", the patient will climb and down one 20cm step during six minute. It will be evaluated by a cardio monitor at rest and every two minutes of the test..
Same as current
Not Provided
Not Provided
 
Reliability, Sensitivity and Validity of the 6 Minute Step Test in Chronic Obstructive Pulmonary Disease (COPD) Patients
Evaluation of Reliability, Sensitivity and Validity of the Six Minute Step Test in Patients With Chronic Obstructive Pulmonary Disease and Its Relation With Predictors Markers of Risk of Death

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 "Unidade Especial de Fisioterapia Respiratória", of the "Universidade Federal de 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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

COPD patients, Healthy Young Subjects, and Healthy Elderly subjects, from a community sample of São Carlos city - São Paulo State - Brazil.

Chronic Obstructive Pulmonary Disease
Not Provided
  • 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 in GOLD stage I
    Patients with clinical and spirometric diagnosis of COPD, with FEV1>80%
  • COPD Patients in GOLD Stage II
    Patients with clinical and spirometric diagnosis of COPD, with FEV1<80% and >50%
  • COPD patients in GOLD stage III and IV
    Patients with clinical and spirometric diagnosis of COPD, with FEV1<50%

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
July 2012
July 2012   (final data collection date for primary outcome measure)

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 a given test or protocol
Both
18 Years to 75 Years
Yes
Contact: Juliano Ferreira Arcuri, Especialist +55 (16) 33518343 julianoarcuri@gmail.com
Contact: Simone Fernandes Davi, Graduation Student +55 (19) 92068352 frsimonef@yahoo.com.br
Brazil
 
NCT01298661
TD6reprod
No
Valéria Amorim Pires Di Lorenzo, Universidade Federal de São Carlos
Universidade Federal de Sao Carlos
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Study Director: Valéria Amorim Pires Di Lorenzo, PhD Universidade Federal de Sao Carlos
Universidade Federal de Sao Carlos
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP