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

October 31, 2013 updated by: Valeria Amorim Pires Di Lorenzo, Universidade Federal de Sao Carlos

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 "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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São Carlos, São Paulo, Brazil, 13561-206
        • Unidade Especial de Fisioterapia Respiratória

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • Exercise Test
Other: 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 Names:
  • Exercise Test
Other: 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 Names:
  • Exercise Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First day or second day of the protocol (random)
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.
On the first or second day of evaluation (random), 30 minutes after the first 6MST.
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First day or second day of the protocol (random)
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.
On the first or second day of evaluation (random), 30 minutes after the first 6MWT.
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.
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.
"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)
Second day
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.
First day or second day of the protocol (random)
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.
First day or second day of the protocol (random), 30 minutes after the first 6MWT
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.
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.
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.
First day or second day of the protocol (random)
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.
First day or second day of the protocol (random), 30 minutes after the first 6MST
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.
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.
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.
First day or second day of the protocol (random)
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.
,First day or second day of the protocol (random) 30 minutes after the first 6MWT
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.
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.
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.
First day or second day of the protocol (random)
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 .
First day or second day of the protocol (random) ,30 minutes after the first 6MST
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.
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.
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.
First day or second day of the protocol (random)
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.
First day or second day of the protocol (random), 30 minutes after the first 6MWT
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.
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.
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.
First day or second day of the protocol (random)
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.
First day or second day of the protocol (random), 30 minutes after the first 6MST
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Sao Carlos

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Study Director: Valéria Amorim Pires Di Lorenzo, PhD, Universidade Federal de Sao Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 17, 2011

First Submitted That Met QC Criteria

February 17, 2011

First Posted (Estimate)

February 18, 2011

Study Record Updates

Last Update Posted (Estimate)

November 26, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TD6reprod

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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