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临床试验/NCT06428227
NCT06428227已完成不适用

A Comparison of Exercise Capacity, Respiratory Functions, and Quality of Life in Heart Failure Patients With and Without Inspiratory Muscle Weakness and Healthy Controls

Gazi University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2010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
102
试验地点
1
主要终点
Functional exercise capacity

研究概览

简要总结

In patients with heart failure, diaphragm dysfunction contributes to decreased quality of life while simultaneously increasing morbidity and mortality. Inspiratory muscle weakness is observed in 30-50% of patients, with the severity of weakness increasing as the disease progresses. Patients exhibit reduced exercise capacity, peripheral and respiratory muscle strength, decreased respiratory function, increased dyspnea, fatigue, and worsened quality of life. However, it is unclear how these parameters will change in patients with inspiratory muscle weakness. Therefore, the study aimed to compare functional exercise capacity, pulmonary function, peripheral muscle strength, dyspnea, fatigue, quality of life and physical activity level in heart failure patients with and without inspiratory muscle weakness and healthy controls

详细描述

It is believed that respiratory muscle abnormalities develop earlier and more extensively than extremity muscle abnormalities in heart failure. Diaphragm dysfunction contributes to decreased quality of life while simultaneously increasing morbidity and mortality. Inspiratory muscle weakness is observed in 30-50% of patients, with the severity of weakness increasing as the disease progresses. Heart failure patients exhibit increased airway resistance and ventilatory response during exercise. Fatigue and dyspnea are common symptoms associated with exercise intolerance and decreased quality of life in heart failure patients.There is no study in the literature comparing functional exercise capacity, pulmonary function, peripheral muscle strength, dyspnea, fatigue, quality of life and physical activity level in heart failure patients with and without inspiratory muscle weakness (IMW). The aim of the study was to compare functional exercise capacity, pulmonary function, peripheral muscle strength, dyspnea, fatigue, quality of life and physical activity level in heart failure patients with and without IMW and healthy controls.

The study was planned as a cross-sectional, retrospective. Heart failure patient were divided into IMW group or not IMW group due to their MIP values. Also healthy controls who were matched for age-gender were included.

研究设计

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

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

  • HF patients were being aged over18 years
  • clinically stable at least four weeks
  • having no change in medications over three months
  • The inclusion criteria for healthy controls were being aged over 18 without a chronic disease

排除标准

  • having unstable angina, acute myocardial infarction, uncontrolled hypertension, significant valvular disease, history of malignancy or orthopedic, rheumatologic, neurological, or pulmonary diseases
  • The exclusion criteria for the healthy controls were having any chronic or systemic disease, and having physical limitation

结局指标

主要结局

Functional exercise capacity

时间窗: First day

According to the American Thoracic Society (ATS) guidelines, the 6-minute walk test (6MWT) was used to evaluate functional exercise capacity

次要结局

  • Respiratory muscle strength(First day)
  • Pulmonary function FVC(First day)
  • Pulmonary function PEF(First day)
  • Pulmonary function FEF25-75(First day)
  • Peripheral muscle strength(First day)
  • Physical activity level(First day)
  • Pulmonary function FEV1(First day)
  • Pulmonary function FEV1/FVC(First day)
  • Fatigue(First day)
  • Dyspnea(First day)
  • The quality of life(Fist day)

研究者

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

Meral Boşnak Güçlü

Professor

Gazi University

研究点 (1)

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