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Heart Failure Worsens Muscle Strength in COPD

Primary Purpose

COPD, CHF, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
isokinetic dynamometer
Cardiopulmonary Exercise Test
Functional Capacity Tests
Lung Function Test
Doppler Echocardiography
Anthropometry and Body Composition
Sponsored by
Mayron Faria de Oliveira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for COPD

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    COPD

    Overlap

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    Clinical 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
    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
    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
    Fat-free mass will be assessed by body composition. All data will be measured in the percentage of predicted values for the Brazilian population.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 3, 2020
    Last Updated
    February 6, 2020
    Sponsor
    Mayron Faria de Oliveira
    Collaborators
    Coordination for the Improvement of Higher Education Personnel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04261452
    Brief Title
    Heart Failure Worsens Muscle Strength in COPD
    Official Title
    Heart Failure Worsens Leg Muscle Strength and Endurance in Patients With Chronic Obstructive Pulmonary Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2014 (Actual)
    Primary Completion Date
    December 1, 2017 (Actual)
    Study Completion Date
    December 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mayron Faria de Oliveira
    Collaborators
    Coordination for the Improvement of Higher Education Personnel

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COPD, CHF, Muscle Weakness

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    COPD
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    Overlap
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    isokinetic dynamometer
    Other Intervention Name(s)
    Muscle Performance
    Intervention Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Cardiopulmonary Exercise Test
    Intervention Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Functional Capacity Tests
    Intervention Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Lung Function Test
    Intervention Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Doppler Echocardiography
    Intervention Description
    The same medical doctor performed all echocardiograms and all patients underwent comprehensive echocardiography.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Anthropometry and Body Composition
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Muscle weakness
    Description
    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.
    Time Frame
    one week after all tests
    Title
    Cardiopulmonary function
    Description
    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.
    Time Frame
    one week after all tests
    Title
    Clinical tests
    Description
    Performance in clinical tests will be assessed by 6MWT and 4-min Step test. All data will be measured in absolute values.
    Time Frame
    one day after all tests
    Title
    Lung Function
    Description
    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.
    Time Frame
    one day after all tests
    Title
    Cardiac Function
    Description
    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.
    Time Frame
    one day after all tests
    Title
    Body composition
    Description
    Fat-free mass will be assessed by body composition. All data will be measured in the percentage of predicted values for the Brazilian population.
    Time Frame
    one day after all tests

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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