The Effect of Inspiratory Muscle Training on Dysfunctional Breathing and Functional Ability in Patients With Chronic Heart Failure. A Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 主要终点
- Diaphragmatic Thickness
研究概览
简要总结
The effect of inspiratory muscle training on breathing pattern and functionality in patients with chronic heart failure.
详细描述
The study protocol aims to examine the impact of inspiratory muscle training on dysfunctional breathing and functional ability in patients with chronic heart failure. Inspiratory muscle training is a low-cost intervention that might improve the breathing pattern, functionality and overall quality of life in patients with chronic heart failure
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults aged ≥ 18 years
- •diagnosis of heart failure within the previous three to twelve months
- •current outpatients in a stable optimal medical regimen for at least 3 months
- •able to perform inspiratory muscle training
- •clinically stable, without hospital admission in the previous 3 months and without participation in any other training program in the previous 6 months
排除标准
- •unstable angina
- •recent acute myocardial infarction
- •uncontrolled hypertension
- •valve disease
- •peripheral arterial disease
- •6MWT assessment of less than 300 meters
- •previous pulmonary disease (forced vital capacity <80% of predicted and/or forced expiratory volume in 1 s <70% of predicted)
- •history of exercise-induced asthma
研究组 & 干预措施
Randomized controlled trial
The intervention group will be trained with inspiratory muscle training for 4 weeks. Inspiratory Muscle Training has been designed to enhance respiratory muscle function through targeted exercises, to strengthen the respiratory muscles, ,thereby improving overall respiratory efficiency
干预措施: Inspiratory muscle training (Device)
Control group
The control group will receive standard care
结局指标
主要结局
Diaphragmatic Thickness
时间窗: From enrollment to the end of treatment at 4 weeks
Diaphragmatic thickness measured by ultrasound is a non-invasive, widely used method to assess diaphragm structure in patients with chronic heart failure. Thickness is measured between the pleural and peritoneal lines at end-expiration and end-inspiration
Dysfunctional breathing
时间窗: From enrollment to the end of treatment at 4 weeks
Dysfunctional breathing refers to abnormal breathing patterns that are often related to the heart's inability to supply blood effectively, affecting respiratory function. Dysfunctional breathing will be assessed with the Hi-Lo breathing test, an observational clinical test used to assess breathing pattern and diaphragm function. The clinician observes and palpates whether the movement is greater under the upper chest hand (Hi) or lower abdomen hand (Lo).The test is scored as "Yes" if upper chest (apical) breathing predominates and "No" if normal diaphragmatic breathing is present.
Functional ability
时间窗: From enrollment to the end of treatment at 4 weeks
Functional ability refers to how well patients can perform daily activities and maintain independence despite their cardiac condition. It will be assessed with the 6-Minute Walk Test (6MWT), a simple and effective tool that evaluates the maximum distance a person can walk in six minutes. The outcome reflects the integrated response of the cardiovascular system mainly, and exercise tolerance.
次要结局
- Functional Dyspnea(From enrollment to the end of treatment at 4 weeks)
- Maximal inspiratory pressure(From enrollment to the end of treatment at 4 weeks)
- Health Related Quality of life(From enrollment to the end of treatment at 4 weeks)
研究者
Georgios Mitsiou
Laboratory Teaching Staff
University of West Attica