Study Results
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Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2014-08-01
2018-12-01
Brief Summary
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The study protocol was reviewed and approved by the Institutional Research Board. All subjects gave written informed consent before participating in the study.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
BASIC_SCIENCE
NONE
Study Groups
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COPD
Body composition was assessed using a body composition. The same medical doctor performed all echocardiograms and all patients underwent comprehensive M-mode echocardiography. Spirometry, gas transfer and static lung volumes were measured in all patients. Resting blood gases were obtained by samples from the radial artery. The six-minute walk test and the four-minute step test were performed. All CPET tests were performed on an electronically braked cycle ergometer and standard metabolic and ventilatory responses were measured breath-by-breath using a calibrated, computer-based system. Knee flexors and extensors muscles were analysed by an isokinetic dynamometer. All patients performed two maximal isokinetic tests: 6 repetitions at 60°/s and 20 repetitions at 300°/s.
isokinetic dynamometer
Knee flexors and extensors muscles were analysed by an isokinetic dynamometer. Positioning of the subjects (sitting with hips flexed to 75°) was standardized based on the length of the thigh and leg to minimize individual differences. Correction for the effect of gravity on neuromuscular performance was accomplished by incorporating limb mass into the calculation of torque production. Previous warm-up was repeated five time with an angular velocity of 400°/s. All patients randomly performed two maximal isokinetic tests: 6 repetitions at 60°/s and 20 repetitions at 300°/s.
Measurements of torque, work (J), power (W) maximum (peak), and fatigue index were obtained in both tests. In addition, data were analysed at percent of prediction (percent pred) by reference values previously described for the Brazilian population, corrected by muscle mass and peak values.
Cardiopulmonary Exercise Test
All exercise tests were performed on an electronically braked cycle ergometer. Standard metabolic and ventilatory responses were measured breath-by-breath using a calibrated, computer-based system.
The incremental exercise test started with 2-min unloaded cycling and increments of 3-10 Watts per min until exhaustion. The anaerobic threshold was estimated by the ventilatory equivalents and V-slope methods and it was determined in agreement by a cardiologist and pulmonologist. Heart rate was determined using the 12-lead electrocardiogram. Throughout the experiment, the pulse hemoglobin saturation (SpO2) was assessed with a pulse oximeter and the 'shortness of breath' was asked at exercise cessation using the 0-10 Borg category ratio scale. All measurements were expressed as percentage predicted for the Brazilian population.
Functional Capacity Tests
The six-minute walk test (6MWT) was in accordance with the American Thoracic Society (ATS). The four-minute step test (4MST) consisted of going up and down a 20-cm high, 40-cm wide and 40-cm long step for 4 minutes.
The investigators measured the heart rate and pulse hemoglobin saturation at rest before each test and every minute of both tests. The investigators assessed dyspnoea and leg fatigue at rest and with the modified Borg scale immediately after finishing the test.
Lung Function Test
Spirometry, gas transfer, and static lung volumes were measured in all patients, and airflow was measured using a "Pitot-tube" based on the American Thoracic Society/European Respiratory Society guidelines. Measurement of maximal inspiratory and expiratory pressures was performed from the residual volume and total lung capacity. Resting blood gases were obtained by samples from the radial artery.
Doppler Echocardiography
The same medical doctor performed all echocardiograms and all patients underwent comprehensive echocardiography.
Anthropometry and Body Composition
Body composition was assessed using a body composition analyzer. Percent body fat was estimated from the resistance and reactance values.
Resistance values and the subject's height (meters), weight (kg), sex, and age (years) were entered into a computer program to estimate percentage of fat, fat mass (FM), and muscle mass (MM).
Overlap
Body composition was assessed using a body composition. The same medical doctor performed all echocardiograms and all patients underwent comprehensive M-mode echocardiography. Spirometry, gas transfer and static lung volumes were measured in all patients. Resting blood gases were obtained by samples from the radial artery. The six-minute walk test and the four-minute step test were performed. All CPET tests were performed on an electronically braked cycle ergometer and standard metabolic and ventilatory responses were measured breath-by-breath using a calibrated, computer-based system. Knee flexors and extensors muscles were analysed by an isokinetic dynamometer. All patients performed two maximal isokinetic tests: 6 repetitions at 60°/s and 20 repetitions at 300°/s.
isokinetic dynamometer
Knee flexors and extensors muscles were analysed by an isokinetic dynamometer. Positioning of the subjects (sitting with hips flexed to 75°) was standardized based on the length of the thigh and leg to minimize individual differences. Correction for the effect of gravity on neuromuscular performance was accomplished by incorporating limb mass into the calculation of torque production. Previous warm-up was repeated five time with an angular velocity of 400°/s. All patients randomly performed two maximal isokinetic tests: 6 repetitions at 60°/s and 20 repetitions at 300°/s.
Measurements of torque, work (J), power (W) maximum (peak), and fatigue index were obtained in both tests. In addition, data were analysed at percent of prediction (percent pred) by reference values previously described for the Brazilian population, corrected by muscle mass and peak values.
Cardiopulmonary Exercise Test
All exercise tests were performed on an electronically braked cycle ergometer. Standard metabolic and ventilatory responses were measured breath-by-breath using a calibrated, computer-based system.
The incremental exercise test started with 2-min unloaded cycling and increments of 3-10 Watts per min until exhaustion. The anaerobic threshold was estimated by the ventilatory equivalents and V-slope methods and it was determined in agreement by a cardiologist and pulmonologist. Heart rate was determined using the 12-lead electrocardiogram. Throughout the experiment, the pulse hemoglobin saturation (SpO2) was assessed with a pulse oximeter and the 'shortness of breath' was asked at exercise cessation using the 0-10 Borg category ratio scale. All measurements were expressed as percentage predicted for the Brazilian population.
Functional Capacity Tests
The six-minute walk test (6MWT) was in accordance with the American Thoracic Society (ATS). The four-minute step test (4MST) consisted of going up and down a 20-cm high, 40-cm wide and 40-cm long step for 4 minutes.
The investigators measured the heart rate and pulse hemoglobin saturation at rest before each test and every minute of both tests. The investigators assessed dyspnoea and leg fatigue at rest and with the modified Borg scale immediately after finishing the test.
Lung Function Test
Spirometry, gas transfer, and static lung volumes were measured in all patients, and airflow was measured using a "Pitot-tube" based on the American Thoracic Society/European Respiratory Society guidelines. Measurement of maximal inspiratory and expiratory pressures was performed from the residual volume and total lung capacity. Resting blood gases were obtained by samples from the radial artery.
Doppler Echocardiography
The same medical doctor performed all echocardiograms and all patients underwent comprehensive echocardiography.
Anthropometry and Body Composition
Body composition was assessed using a body composition analyzer. Percent body fat was estimated from the resistance and reactance values.
Resistance values and the subject's height (meters), weight (kg), sex, and age (years) were entered into a computer program to estimate percentage of fat, fat mass (FM), and muscle mass (MM).
Interventions
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isokinetic dynamometer
Knee flexors and extensors muscles were analysed by an isokinetic dynamometer. Positioning of the subjects (sitting with hips flexed to 75°) was standardized based on the length of the thigh and leg to minimize individual differences. Correction for the effect of gravity on neuromuscular performance was accomplished by incorporating limb mass into the calculation of torque production. Previous warm-up was repeated five time with an angular velocity of 400°/s. All patients randomly performed two maximal isokinetic tests: 6 repetitions at 60°/s and 20 repetitions at 300°/s.
Measurements of torque, work (J), power (W) maximum (peak), and fatigue index were obtained in both tests. In addition, data were analysed at percent of prediction (percent pred) by reference values previously described for the Brazilian population, corrected by muscle mass and peak values.
Cardiopulmonary Exercise Test
All exercise tests were performed on an electronically braked cycle ergometer. Standard metabolic and ventilatory responses were measured breath-by-breath using a calibrated, computer-based system.
The incremental exercise test started with 2-min unloaded cycling and increments of 3-10 Watts per min until exhaustion. The anaerobic threshold was estimated by the ventilatory equivalents and V-slope methods and it was determined in agreement by a cardiologist and pulmonologist. Heart rate was determined using the 12-lead electrocardiogram. Throughout the experiment, the pulse hemoglobin saturation (SpO2) was assessed with a pulse oximeter and the 'shortness of breath' was asked at exercise cessation using the 0-10 Borg category ratio scale. All measurements were expressed as percentage predicted for the Brazilian population.
Functional Capacity Tests
The six-minute walk test (6MWT) was in accordance with the American Thoracic Society (ATS). The four-minute step test (4MST) consisted of going up and down a 20-cm high, 40-cm wide and 40-cm long step for 4 minutes.
The investigators measured the heart rate and pulse hemoglobin saturation at rest before each test and every minute of both tests. The investigators assessed dyspnoea and leg fatigue at rest and with the modified Borg scale immediately after finishing the test.
Lung Function Test
Spirometry, gas transfer, and static lung volumes were measured in all patients, and airflow was measured using a "Pitot-tube" based on the American Thoracic Society/European Respiratory Society guidelines. Measurement of maximal inspiratory and expiratory pressures was performed from the residual volume and total lung capacity. Resting blood gases were obtained by samples from the radial artery.
Doppler Echocardiography
The same medical doctor performed all echocardiograms and all patients underwent comprehensive echocardiography.
Anthropometry and Body Composition
Body composition was assessed using a body composition analyzer. Percent body fat was estimated from the resistance and reactance values.
Resistance values and the subject's height (meters), weight (kg), sex, and age (years) were entered into a computer program to estimate percentage of fat, fat mass (FM), and muscle mass (MM).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* moderate-to-severe COPD according to GOLD classification (FEV1/ FVC \<0.7 and predicted post-bronchodilator FEV1 between 30% and 80%)
* no clinical or echocardiographic evidence of HF for the COPD group
* echocardiographic evidence of HF with reduced left ventricular ejection fraction (\<40%) for the overlap group
* chronic dyspnoea (MRC scale score 2-4)
* NYHA class 2 or 3.
Exclusion Criteria
* recent (within a year) rehabilitation program
* osteomuscular limitation
* type I or non-controlled type II diabetes mellitus
* peripheral arterial disease associated with claudication
* Patients with preserved ejection fraction HF
30 Years
ALL
No
Sponsors
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Coordination for the Improvement of Higher Education Personnel
OTHER
Mayron Faria de Oliveira
OTHER
Responsible Party
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Mayron Faria de Oliveira
Clinical Investigator
Other Identifiers
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1275295
Identifier Type: -
Identifier Source: org_study_id
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