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临床试验/NCT04350541
NCT04350541暂停不适用

Heart Failure Associated With Chronic Obstructive Lung Disease and Maximum Exercise Tolerance: Evaluation of the Distribution and Pulmonary Deposition of Radioaerosol, Peripheral and Coronary Endothelial Function, Brain Natriuretic Peptide

Universidade Federal de Pernambuco1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
40
试验地点
1
主要终点
Peripheral endothelial function

研究概览

简要总结

INTRODUCTION: The complexity of the pathophysiology of heterogeneous diseases such as heart failure and obstructive pulmonary disease causes a different approach to these diseases or with a view as much as a better understanding of the same situations, with which the clinical profile of patients who are associated with an association is. It is known that regular physical training promotes progressive improvements in exercise tolerance, in the pulmonary ventilation / perfusion ratio and in respiratory function by strengthening. OBJECTIVE: To compare the effects of high-intensity interval training and continuous aerobic exercise, with peripheral endothelial function, brain natriuretic peptide levels, maximum exercise tolerance, distribution of lung volumes and quality of life of patients with obstructive pulmonary disease associated with heart failure. METHODS: This is a clinical, controlled, randomized and blinded trial. Peripheral endothelial function, tolerance to maximum and submaximal exercise, distribution of lung volumes, quality of life, presence of symptoms of depression and perception of clinical change will be evaluated. EXPECTED RESULTS: Incorporate into the care of these patients, new effective therapeutic approaches, of low cost and with greater technical and scientific evidence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Sedentary individuals with Heart Failure of all etiologies;
  • •Diagnosed moderate and severe chronic obstructive pulmonary disease;
  • •Clinical stability;
  • •No change in the medication class within three months before the beginning of the research.

排除标准

  • •Unstable angina;
  • •Myocardial infarction;
  • •Previous cardiac surgery up to three months before the beginning of the study;
  • •Hemodynamic instability;
  • •Orthopedic and neurological diseases;
  • •Psychological and/or mental impairment.

研究组 & 干预措施

Interval training

Experimental

Interval training will consist of 10 minutes of warm-up between 40-50% of the peak oxygen consumption (VO2peak), followed by four to six repetitions of three-minute intervals between 80-90% of VO2peak and three minutes between 40-50% VO2peak and finally, five minutes of cooling down between 30-40% of VO2peak.

干预措施: High-intensity interval training (Other)

Continuous training

Active Comparator

The continuous aerobic training will consist of 10 minutes of warm-up with intensity between 40 and 50% of VO2peak, 20 minutes of conditioning between 60 and 70% of VO2peak and 5 minutes of cooling down between 30 and 40% of VO2peak.

干预措施: Continuous aerobic training (Other)

结局指标

主要结局

Peripheral endothelial function

时间窗: 24 weeks

Evaluated by the peripheral arterial tonometry using the EndoPat 2000 device

Exercise tolerance

时间窗: 24 weeks

Evaluated by the cardiopulmonary exercise test by measuring the maximum oxygen consumption.

次要结局

  • Perception of clinical change(24 weeks)
  • Quality of life assessment: Short Form-36 questionnaire(24 weeks)
  • Distance covered in the six-minute walk test(24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

BRUNA THAYS SANTANA DE ARAÚJO

physiotherapist, clinical research

Universidade Federal de Pernambuco

研究点 (1)

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