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临床试验/NCT03701854
NCT03701854已完成不适用

Comparison of Functional and Maximal Exercise Capacity, Respiratory and Peripheral Muscle Strength, Dyspnea and Fatigue in Heart Failure Patients With Pacemakers and Healthy Controls

Gazi University1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
138
试验地点
1
主要终点
submaximal exercise capacity evaluation

研究概览

简要总结

Despite major breakthroughs that have recently been made in pacemakers implanted in heart failure (HF) patients, it is clear that functional impairments and symptoms often remain. However, only limited studies have investigated exercise capacity, muscle strength, pulmonary function, dyspnea, and fatigue in pacemaker implanted HF patients. Therefore, investigators aimed to compare the aforementioned outcomes in patients and healthy controls.

详细描述

Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood through to meet the body's needs for blood and oxygen. Safeguarding HF patients at increased risk of sudden cardiac death due to ventricular arrhythmias and HF as a result of left ventricular systolic dysfunction and cardiac abnormal synchronization has continued to improve. Implantable cardioverter defibrillators (ICDs), which restore normal heart rhythm using pacing, cardioversion or defibrillation, and cardiac resynchronization therapy (CRT), which resynchronizes the contraction of the heart using biventricular pacing, are nowadays widely used to treat the aforementioned conditions.

New developments in medical treatments have focused on the primary affected organs, targeting reduced left ventricular ejection fraction in chronic HF. Although major breakthroughs in the treatments have occurred in recent years, especially implantable medical devices, it is clear that when drugs are optimally prescribed, even the latest technology used in pacemakers reported problems, especially functional impairments and symptoms often remain. In recent decades, it has become obvious that disease severity should not be estimated from cardiac function impairment alone. However, what has not hitherto been clearly investigated is the fact that even functional and maximal exercise capacity, respiratory and peripheral muscle strength and pulmonary function are impaired, and dyspnea in the activities of daily living and fatigue perception increased in HF patients with pacemakers.

Hence, investiators designed a prospective, cross-sectional study to compare the aforementioned outcomes in HF patients with pacemakers and healthy controls. Investigators hypothesized that functional and maximal exercise capacity, respiratory and peripheral muscle strength, and pulmonary function are impaired, and dyspnea in the activities of daily living, and fatigue perception increased in HF patients with pacemakers.

A cross-sectional study. 50 HF patients with pacemakers and 40 controls were compared. Functional (6-Minute Walking test (6-MWT)) and maximal exercise capacity (Incremental Shuttle Walking test (ISWT)), respiratory (MIP, MEP; Mouth pressure device) and peripheral muscle strength (Dynamometer), pulmonary function (Spirometry) dyspnea (Modified Medical Research Council Dyspnea scale) (MMRC)), and fatigue (Fatigue Severity scale (FSS)) were evaluated.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

submaximal exercise capacity evaluation

时间窗: 8-10 minutes

The six-minute walking test (6-MWT) was used to evaluate submaximal exercise capacity.

次要结局

  • inspiratory and expiratory muscle strength (MIP, MEP)(5-10 minutes)
  • peripheral muscle strength(10 minutes)
  • fatigue severity(1-3 minutes)
  • pulmonary function test(5 minutes)
  • Dyspnea severity(2 minutes)
  • maximal exercise capacity evaluation(10-15 minutes)

研究者

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

Meral Boşnak Güçlü

Associate professor

Gazi University

研究点 (1)

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