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Clinical Trials/NCT04261452
NCT04261452
Completed
Not Applicable

Heart Failure Worsens Leg Muscle Strength and Endurance in Patients With Chronic Obstructive Pulmonary Disease

Mayron Faria de Oliveira0 sites50 target enrollmentAugust 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD
Sponsor
Mayron Faria de Oliveira
Enrollment
50
Primary Endpoint
Cardiopulmonary function
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2014
End Date
December 1, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Mayron Faria de Oliveira
Responsible Party
Sponsor Investigator
Principal Investigator

Mayron Faria de Oliveira

Clinical Investigator

Federal University of São Paulo

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

Outcomes

Primary Outcomes

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.

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.

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.

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.

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