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

This study has been completed.
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Valeria Amorim Pires Di Lorenzo, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier:
NCT01298661
First received: February 17, 2011
Last updated: October 31, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Other: Six-minute Step Test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Sao Carlos:

Primary Outcome Measures:
  • First "Six Minute Step Test" Performance [ Time Frame: First day or second day of the protocol (random) ] [ Designated as safety issue: No ]
    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 [ Time Frame: On the first or second day of evaluation (random), 30 minutes after the first 6MST. ] [ Designated as safety issue: No ]
    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 [ 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. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • First "Six Minute Walk Test" Distance [ Time Frame: First day or second day of the protocol (random) ] [ Designated as safety issue: No ]
    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.

  • Second "Six Minute Walk Test" Distance [ Time Frame: On the first or second day of evaluation (random), 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 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 [ 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. ] [ Designated as safety issue: No ]
    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.

  • "Body-Mass Index, Airflow Obstruction, Dyspnea, Exercise Capacity" Index (BODE Index) [ Time Frame: Second day ] [ Designated as safety issue: No ]

    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 [ Time Frame: First day or second day of the protocol (random) ] [ Designated as safety issue: No ]
    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 [ Time Frame: First day or second day of the protocol (random), 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 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 [ 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: First day or second day of the protocol (random) ] [ Designated as safety issue: No ]
    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 [ Time Frame: First day or second day of the protocol (random), 30 minutes after the first 6MST ] [ Designated as safety issue: No ]
    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 [ 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: First day or second day of the protocol (random) ] [ Designated as safety issue: No ]
    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 [ Time Frame: ,First day or second day of the protocol (random) 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 far as it can in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • First "Six Minute Step Test" Peripheral Oxygen Saturation [ Time Frame: First day or second day of the protocol (random) ] [ Designated as safety issue: No ]
    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 [ Time Frame: First day or second day of the protocol (random) ,30 minutes after the first 6MST ] [ Designated as safety issue: No ]
    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 [ 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: First day or second day of the protocol (random) ] [ Designated as safety issue: No ]
    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 [ Time Frame: First day or second day of the protocol (random), 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 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 [ 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: First day or second day of the protocol (random) ] [ Designated as safety issue: No ]
    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 [ Time Frame: First day or second day of the protocol (random), 30 minutes after the first 6MST ] [ Designated as safety issue: No ]
    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 [ 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 91
Study Start Date: February 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Healthy Young Subjects
Subjects apparently healthy, with age of 18 to 27 years old.
Other: Six-minute Step Test
The patients underwent a test where they need to step up and down a 20cm test during six minutes.
Other Name: Exercise Test
Healthy Elderly subjects
Subjects apparently healthy, with age of 60 to 75 years old.
Other: Six-minute Step Test
The patients underwent a test where they need to step up and down a 20cm test during six minutes.
Other Name: Exercise Test
COPD Patients
Patients with clinical and spirometric diagnosis of COPD
Other: Six-minute Step Test
The patients underwent a test where they need to step up and down a 20cm test during six minutes.
Other Name: Exercise Test

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298661

Locations
Brazil
Unidade Especial de Fisioterapia Respiratória
São Carlos, São Paulo, Brazil, 13561-206
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Study Director: Valéria Amorim Pires Di Lorenzo, PhD Universidade Federal de Sao Carlos
  More Information

Publications:

Responsible Party: Valeria Amorim Pires Di Lorenzo, PhD, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT01298661     History of Changes
Other Study ID Numbers: TD6reprod
Study First Received: February 17, 2011
Results First Received: April 16, 2013
Last Updated: October 31, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Federal de Sao Carlos:
Exercise Test
Reproducibility of Results
Mortality

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 31, 2014