Effects of High Intensity Interval-Based Inspiratory Muscle Training in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Arterial stiffness
研究概览
简要总结
The aim of this study is to investigate the potential effects of inspiratory muscle training on cardiovascular, respiratory, physical, and psychosocial functions in patients with heart failure.
详细描述
Heart failure is a syndrome that leads to decreased cardiac output, inflammation, increased catabolism, and prolonged immobilization, causing inspiratory muscle weakness. Cardiac rehabilitation is a well-known treatment approach in heart failure however, the participation rate in cardiac rehabilitation is low. Therefore, inspiratory muscle training may serve as an alternative approach in patients with heart failure.
Patients will be randomly allocated into the inspiratory muscle training group and control group. The inspiratory muscle training (IMT) group will carry out IMT sessions three days per week for 8 weeks by using an inspiratory threshold loading device. Each session will consist of seven cycles including 2 min of breathing on an inspiratory loading device followed by 1 min of rest and will last 21 min. IMT will be performed at the tolerable maximum load for each 2-min work interval and will be progressively increased over the 8 weeks. The control group will perform unloaded IMT by using an inspiratory threshold loading device during all training sessions. Data will be collected before and after the treatment by a masked outcome assessor.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of heart failure with reduced ejection fraction
- •Clinically stable
- •Functional class II-III according to the New York Heart Association functional classification
- •Having inspiratory muscle weakness (MIP<70%)
- •Volunteer to participation
排除标准
- •Congenital heart disease
- •Severe valvular heart disease
- •Cardiac device such as implantable cardioverter defibrillator or cardiac resynchronization therapy
- •Neurological disease
- •Conditions that may limit the physical mobility
结局指标
主要结局
Arterial stiffness
时间窗: change from baseline to 8 weeks
Arterial stiffness will be measured using a SphygmoCor device.
Heart rate variability
时间窗: change from baseline to 8 weeks
Heart rate variability analysis, which gives information about the cardiac autonomic function, will be obtained from a short-term 5-min ECG recording using a SphygmoCor device.
次要结局
- Forced vital capacity (FVC)(change from baseline to 8 weeks)
- Diaphragm thickness(change from baseline to 8 weeks)
- Functional capacity(change from baseline to 8 weeks)
- Maximal inspiratory pressure(change from baseline to 8 weeks)
- Maximal expiratory pressure(change from baseline to 8 weeks)
- Dyspnea(change from baseline to 8 weeks)
- Disease-specific quality of life(change from baseline to 8 weeks)
- Forced expiratory flow at 25-75% of the vital capacity (FEF 25-75%)(change from baseline to 8 weeks)
- Quadriceps muscle strength(change from baseline to 8 weeks)
- Fatigue(change from baseline to 8 weeks)
- Forced expiratory volume in 1 second (FEV1)(change from baseline to 8 weeks)
- Respiratory muscle endurance(change from baseline to 8 weeks)
- Balance(change from baseline to 8 weeks)
- Physical activity(change from baseline to 8 weeks)
- Frailty(change from baseline to 8 weeks)
- Health-related quality of life(change from baseline to 8 weeks)
研究者
Aylin Tanriverdi
Research assistant
Dokuz Eylul University