COPDNCT04261452
Heart Failure Worsens Muscle Strength in COPD
A study testing isokinetic dynamometer, Cardiopulmonary Exercise Test and Functional Capacity Tests in people with COPD and CHF, run by Mayron Faria de Oliveira.
Trial summary
The combination of heart failure (HF) and chronic obstructive pulmonary disease (COPD) is highly prevalent, but underdiagnosed and poorly recognized. It has been suggested that the decline in functional capacity is associated with musculoskeletal and systemic changes than primary organ (heart and/or lung) failure. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- COPD, CHF, Muscle Weakness
- What is being tested?
- isokinetic dynamometer, Cardiopulmonary Exercise Test and Functional Capacity Tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2014to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-cachectic sedentary patients
- 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.
Who cannot join
- long-term O2 therapy
- 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
About this study
Official title: Heart Failure Worsens Leg Muscle Strength and Endurance in Patients With Chronic Obstructive Pulmonary Disease
The combination of heart failure (HF) and chronic obstructive pulmonary disease (COPD) is highly prevalent, but underdiagnosed and poorly recognized. It has been suggested that the decline in functional capacity is associated with musculoskeletal and systemic changes than primary organ (heart and/or lung) failure. In addition, it is recognized that both diseases have several mechanisms that are responsible for musculoskeletal impairment. However, the association of reduced systemic perfusion with low oxygen content observed in the association of HF and COPD may contribute to the worsening of the components of the muscle impairment cascade. Thus, muscle strength and fatigue may not only be even more altered but may also be the main determinants of functional capacity in patients with coexistence of HF and COPD. Although many studies have evaluated the muscle performance of patients with HF or COPD, the literature did not show data on worsening due to the association of the diseases. Particularities identification of the muscle impairment in the coexistence of HF and COPD is fundamental for the development of rehabilitation strategies, mainly through physical exercise. In this line, the present study tested the hypothesis that the coexistence of HF and COPD could present lower values of strength and greater fatigue. Similarly, the muscle dysfunction degree could strongly correlate with the performance markers of the incremental or functional tests in patients with HF associated with COPD.
The study protocol was reviewed and approved by the Institutional Research Board. All subjects gave written informed consent before participating in the study.
- Conditions
- COPD, CHF, Muscle Weakness
- Being tested
- isokinetic dynamometer, Cardiopulmonary Exercise Test, Functional Capacity Tests, Lung Function Test, Doppler Echocardiography
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isokinetic dynamometerDiagnostic test
Also called Muscle Performance
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 TestDiagnostic 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 TestsDiagnostic test
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 TestDiagnostic 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 EchocardiographyDiagnostic test
The same medical doctor performed all echocardiograms and all patients underwent comprehensive echocardiography.
Anthropometry and Body CompositionDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| COPD | Other | 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. Receives: Diagnostic Test: isokinetic dynamometer; Diagnostic Test: Cardiopulmonary Exercise Test; Diagnostic Test: Functional Capacity Tests; Diagnostic Test: Lung Function Test; Diagnostic Test: Doppler Echocardiography; Diagnostic Test: Anthropometry and Body Composition |
| Overlap | Other | 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. Receives: Diagnostic Test: isokinetic dynamometer; Diagnostic Test: Cardiopulmonary Exercise Test; Diagnostic Test: Functional Capacity Tests; Diagnostic Test: Lung Function Test; Diagnostic Test: Doppler Echocardiography; Diagnostic Test: Anthropometry and Body Composition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle weakness
Muscle performance will be assessed by an isokinetic dynamometer. All data will be measured in absolute values and the percentage of predicted values for the Brazilian population.
Measured: one week after all tests
Cardiopulmonary function
Exercise capacity will be assessed by the cardiopulmonary test. All data will be measured in absolute values (ml/kg) and the percentage of predicted values for the Brazilian population.
Measured: one week after all tests
Clinical tests
Performance in clinical tests will be assessed by 6MWT and 4-min Step test. All data will be measured in absolute values.
Measured: one day after all tests
Lung Function
Clinical obstruction data will be assessed by total body plethysmography. All data will be measured in absolute values and percentage of predicted values for the Brazilian population.
Measured: one day after all tests
Cardiac Function
An echocardiogram will be performed to assess all cardiac functions. All data will be measured in the percentage of predicted values for the Brazilian population.
Measured: one day after all tests
Body composition
Fat-free mass will be assessed by body composition. All data will be measured in the percentage of predicted values for the Brazilian population.
Measured: one day after all tests
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start1 Aug 2014
- Primary completion1 Dec 2017
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayron Faria de Oliveira
- Sponsor type
- University, hospital or other
- Collaborators
- Coordination for the Improvement of Higher Education Personnel
- Responsible party
- Sponsor-investigator, Mayron Faria de Oliveira, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261452
- Sponsor's protocol ID
- 1275295
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Worsens Leg Muscle Strength and Endurance in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04261452
- Acronym / sponsor ID
- 1275295
- Conditions
- COPD, CHF, Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayron Faria de OliveiraUniversity, hospital or other
- Collaborators
- Coordination for the Improvement of Higher Education Personnel
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The combination of heart failure (HF) and chronic obstructive pulmonary disease (COPD) is highly prevalent, but underdiagnosed and poorly recognized. It has been suggested that the decline in functional capacity is associated with musculoskeletal and systemic changes than primary organ (heart and/or lung) failure. In addition, it is recognized that both diseases have several mechanisms that are responsible for musculoskeletal impairment. However, the association of reduced systemic perfusion with low oxygen content observed in the association of HF and COPD may contribute to the worsening of the components of the muscle impairment cascade. Thus, muscle strength and fatigue may not only be even more altered but may also be the main determinants of functional capacity in patients with coexistence of HF and COPD. Although many studies have evaluated the muscle performance of patients with HF or COPD, the literature did not show data on worsening due to the association of the diseases. Particularities identification of the muscle impairment in the coexistence of HF and COPD is fundamental for the development of rehabilitation strategies, mainly through physical exercise. In this line, the present study tested the hypothesis that the coexistence of HF and COPD could present lower values of strength and greater fatigue. Similarly, the muscle dysfunction degree could strongly correlate with the performance markers of the incremental or functional tests in patients with HF associated with COPD.
The study protocol was reviewed and approved by the Institutional Research Board. All subjects gave written informed consent before participating in the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD | Other | Diagnostic Test: isokinetic dynamometer, Diagnostic Test: Cardiopulmonary Exercise Test, Diagnostic Test: Functional Capacity Tests, Diagnostic Test: Lung Function Test, Diagnostic Test: Doppler Echocardiography, Diagnostic Test: Anthropometry and Body CompositionBody 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. |
| Overlap | Other | Diagnostic Test: isokinetic dynamometer, Diagnostic Test: Cardiopulmonary Exercise Test, Diagnostic Test: Functional Capacity Tests, Diagnostic Test: Lung Function Test, Diagnostic Test: Doppler Echocardiography, Diagnostic Test: Anthropometry and Body CompositionBody 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- non-cachectic sedentary patients
- 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)
Key exclusion criteria (6 listed)
- long-term O2 therapy
- recent (within a year) rehabilitation program
- osteomuscular limitation
- type I or non-controlled type II diabetes mellitus
- peripheral arterial disease associated with claudication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isokinetic dynamometerAlso: Muscle PerformanceKnee 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. | Diagnostic test | COPD, Overlap |
| Cardiopulmonary Exercise TestAll 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. | Diagnostic test | COPD, Overlap |
| Functional Capacity TestsThe 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. | Diagnostic test | COPD, Overlap |
| Lung Function TestSpirometry, 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. | Diagnostic test | COPD, Overlap |
| Doppler EchocardiographyThe same medical doctor performed all echocardiograms and all patients underwent comprehensive echocardiography. | Diagnostic test | COPD, Overlap |
| Anthropometry and Body CompositionBody 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). | Diagnostic test | COPD, Overlap |
Primary outcome
Muscle weakness
Time frame: one week after all tests
Muscle performance will be assessed by an isokinetic dynamometer. All data will be measured in absolute values and the percentage of predicted values for the Brazilian population.
Cardiopulmonary function
Time frame: one week after all tests
Exercise capacity will be assessed by the cardiopulmonary test. All data will be measured in absolute values (ml/kg) and the percentage of predicted values for the Brazilian population.
Clinical tests
Time frame: one day after all tests
Performance in clinical tests will be assessed by 6MWT and 4-min Step test. All data will be measured in absolute values.
Lung Function
Time frame: one day after all tests
Clinical obstruction data will be assessed by total body plethysmography. All data will be measured in absolute values and percentage of predicted values for the Brazilian population.
Cardiac Function
Time frame: one day after all tests
An echocardiogram will be performed to assess all cardiac functions. All data will be measured in the percentage of predicted values for the Brazilian population.
Body composition
Time frame: one day after all tests
Fat-free mass will be assessed by body composition. All data will be measured in the percentage of predicted values for the Brazilian population.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing isokinetic dynamometer, Cardiopulmonary Exercise Test and Functional Capacity Tests in people with COPD and CHF, run by Mayron Faria de Oliveira.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle weakness (time frame: one week after all tests). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.