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Completed

NCT Number: NCT01298661

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unidade Especial de Fisioterapia Respiratória

São Carlos, São Paulo, 13561-206, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Six-minute step test

Other

The patients underwent a test where they need to step up and down a 20cm test during six minutes.

Other names: Exercise Test

Primary outcomes

  1. First "Six Minute Step Test" Performance

    Time frame: First day or second day of the protocol (random)

    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.

  2. Second "Six Minute Step Test" Performance

    Time frame: On the first or second day of evaluation (random), 30 minutes after the first 6MST.

    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.

  3. 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.

    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 outcomes

  1. First "Six Minute Walk Test" Distance

    Time frame: First day or second day of the protocol (random)

    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.

  2. Second "Six Minute Walk Test" Distance

    Time frame: On the first or second day of evaluation (random), 30 minutes after the first 6MWT.

    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.

  3. 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.

    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.

  4. "Body-Mass Index, Airflow Obstruction, Dyspnea, Exercise Capacity" Index (BODE Index)

    Time frame: Second day

    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)

  5. First "Six Minute Walk Test" Exertion Perception

    Time frame: First day or second day of the protocol (random)

    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.

  6. Second "Six Minute Walk Test" Exertion Perception

    Time frame: First day or second day of the protocol (random), 30 minutes after the first 6MWT

    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.

  7. 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.

    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.

  8. First "Six Minute Step Test" Exertion Perception

    Time frame: First day or second day of the protocol (random)

    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.

  9. Second "Six Minute Step Test" Exertion Perception

    Time frame: First day or second day of the protocol (random), 30 minutes after the first 6MST

    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.

  10. 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.

    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.

  11. First "Six Minute Walk Test" Peripheral Oxygen Saturation

    Time frame: First day or second day of the protocol (random)

    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.

  12. 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

    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.

  13. 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.

    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.

  14. First "Six Minute Step Test" Peripheral Oxygen Saturation

    Time frame: First day or second day of the protocol (random)

    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.

  15. 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

    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 .

  16. 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.

    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.

  17. First "Six Minute Walk Test" Heart Rate

    Time frame: First day or second day of the protocol (random)

    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.

  18. Second "Six Minute Walk Test" Heart Rate

    Time frame: First day or second day of the protocol (random), 30 minutes after the first 6MWT

    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.

  19. 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.

    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.

  20. First "Six Minute Step Test" Heart Rate

    Time frame: First day or second day of the protocol (random)

    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.

  21. Second "Six Minute Step Test" Heart Rate

    Time frame: First day or second day of the protocol (random), 30 minutes after the first 6MST

    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.

  22. 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.

    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.

Sponsors and collaborators

Lead sponsor

Universidade Federal de Sao Carlos

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 18, 2011
Registry last updated
Nov 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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