CARDIOINSPIRE - Effectiveness of Adding Inspiratory Muscle Training to a Cardiac Rehabilitation Program for People With Ischemic Heart Disease Revascularized by Percutaneous Transluminal Coronary Angioplasty.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Functional Capacity
研究概览
简要总结
Myocardial Ischemia (MI) consists of the narrowing of the internal lumen of the arteries that perfuse the heart. As the section of the artery decreases, so does the blood flow and therefore the supply of oxygen to the myocardium, which can cause angina pectoris or even an acute myocardial infarction. It is the leading cause of death from cardiovascular disease, responsible for 9.44 million deaths in 2021 and 185 million disability-adjusted life years. For this reason, it is one of the most important public health problems in all countries in the world that entails high health and social spending.
The non-pharmacological strategy with the most evidence currently to improve the quality of life of patients and also prevent subsequent cardiovascular events are cardiac rehabilitation programs (CRP). These include smoking cessation, control of other cardiovascular risk factors, health education, psychological therapy and a multimodal exercise program. Two types of exercise are performed, cardiovascular or aerobic resistance and strength. There is limited evidence on the addition of inspiratory muscle training (IMT) in people with MI. For this reason, it is not routinely recommended in clinical practice guidelines. Therefore, this thesis project, based on a clinical trial, tries to increase knowledge on this topic.
In view of the above, the main objective of this project is to analyze the effectiveness of adding inspiratory muscle training to a CRP of people with ischemic heart disease revascularized by percutaneous transluminal coronary angioplasty (PTCA) after 16 intervention sessions, based on to functional capacity, in addition to muscle strength, social support, anxiety, depression, coping with the disease, sexual dysfunction, quality of life, quality of sleep, eating habits and body composition. On the other hand, the secondary objectives are to know the biopsychosocial profile of this population and analyze gender differences through a subgroup analysis.
To achieve these objectives, a low-risk randomized and controlled clinical trial will be carried out in parallel at the Virgen de la Victoria University Hospital in Málaga (HUVV). People from this health area diagnosed with MI who have undergone PTCA will be recruited. The control group will complete the usual 8-week cardiac rehabilitation program with 2 weekly sessions of multicomponent exercise (cardiovascular and strength), one weekly session of health education and another of group psychological therapy. The intervention group will do the same program to which an IMT will be added. It will be performed with loads of 70% of the Maximum Inspiratory Pressure (MIP) value, completing 3 sets of 10 repetitions, 4 days a week, with 3 minutes of rest between sets, during the 8 weeks that the PRC lasts. Different measurements will be made and various tests and questionnaires will be passed before and after the PRC and the effect of adding or not adding the IMT on the variables to be analyzed will be analyzed using statistical methods.
It is expected that some of the variables will improve since there is some evidence (low and moderate) of this, as concluded by a recent review. Furthermore, in similar clinical populations such as patients with heart failure (HF), there is a high level of evidence that several of these parameters improve. Therefore, it can be expected that the results are similar in MI. In those variables without prior evidence, we hypothesize that there will be an improvement, since increasing MIP in isolation has been shown, in different clinical populations, to improve the functional capacity and quality of life of the study subjects.
If the expected benefits are finally observed, the current evidence on the use of IMT in CRPs for people with MI and PTCA will increase. In anticipation of the accumulated evidence of the effectiveness of the proposed treatment, the results derived from the present study may recommend including the IMT as another fundamental component of the CRP for this subgroup of patients.
详细描述
Myocardial ischemia According to the Spanish Heart Foundation, myocardial ischemia (MI) is the disease caused by atherosclerosis of the coronary arteries, responsible for providing blood to the heart muscle. Coronary atherosclerosis is a slow process of collagen formation and accumulation of lipids (fats) and inflammatory cells (lymphocytes) that causes narrowing of the lumen of the coronary arteries. This process begins in the first decades of life, but does not present symptoms until the stenosis of the coronary artery becomes so severe that it causes an imbalance between the supply of oxygen to the myocardium and its metabolic needs3. In this case, myocardial ischemia occurs, which may be chronic, known as chronic coronary syndrome or stable angina pectoris, or sudden occlusion due to thrombosis of the artery, which causes a lack of oxygenation of the myocardium that gives rise to coronary syndrome. Acute also called unstable angina and acute myocardial infarction. MI reduces force production, causes arrhythmias, and causes muscle damage, leading to acute ischemic contractile failure of the heart. Patients with chronic ischemic heart disease have lower evaluations of their social life and their coping with daily routine.
The consequence of the processes described above is that people who suffer from MI decrease their tolerance to exercise, functionality and performance in activities of daily living, which leads them to sedentary behaviors, worsening their quality of life. Furthermore, a vicious circle of inactivity and clinical and functional deterioration is established that produces a general worsening of physical condition and atrophy of peripheral and respiratory muscles. All of these circumstances lead to a decrease in functional capacity and therefore to a worse prognosis of the disease.
Regarding the risk factors that lead to the development of MI, there is a combination of socioeconomic, metabolic, behavioral and environmental risk factors. Among them are advanced age, high blood pressure, an unhealthy diet, high cholesterol, diabetes, obesity, smoking, a sedentary lifestyle, stress, family history and harmful consumption of toxins, among others. Most of these factors are modifiable and it is one of the fundamental pillars of their treatment to get affected people to change their lifestyle. The incidence is higher in men since women benefit from a hormonal protective effect during their fertile life. This circumstance disappears with menopause, which equalizes the cases in both sexes from 45-50 years of age.
Epidemiology It is estimated that in 2020 there were 244.1 million people living with MI worldwide. Of them, 141 million were men and 103.1 million were women. The regions of North Africa, the Middle East, Central Asia, South Asia and Eastern Europe had the highest prevalence rates. The global mortality rate was 112.37 per 100,000, this being also higher in the regions with the highest prevalence.
MI affects approximately 126 million people worldwide, representing 1.72% of the world's population. It is the main cause of death, with 9 million deaths annually. The incidence begins to increase in the fourth decade of life and is higher in men than in women. In developed countries, about a third of all deaths in people over 35 years of age are attributed to this disease. In the United States, it is estimated that almost half of men and approximately one-third of women will experience some symptoms of MI during their lifetime. In the European Union, cardiovascular diseases account for 40% of all deaths. Furthermore, the economic costs associated with MI are significant. The treatment of cardiovascular diseases constitutes 54% of total health expenditure, and contributes approximately a quarter of productivity losses.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- 否
入选标准
- •people with Myocardial Ischemia and percutaneous transluminal coronary angioplasty
- •both sexes
- •over 18 years old
- •under 80 years of age
- •absence of cognitive deficits and/or physical limitations that would prevent them from performing physical exercise or completing the questionnaires required for participation in the study.
排除标准
- •disease or condition that contraindicates exercise such as severe hypertrophic obstructive cardiomyopathy
- •severe aortic stenosis and/or dissecting aortic aneurysm
- •patients who refuse treatment or do not sign the informed consent.
研究组 & 干预措施
Inspiratory muscle training group
The intervention group will be given an inspiratory muscle training device that will be regulated at 70% of their Maximum Inspiratory Pressure. This load is able to induce improvements in their musculature.
干预措施: Inspiratory muscle training (Device)
Control group
The control group will be given an inspiratory muscle training device that will be regulated with a load of 5 cm H2O. This load is not sufficient to induce changes in the musculature, so it will function as a placebo.
干预措施: Sham Inspiratory muscle training (Device)
结局指标
主要结局
Functional Capacity
时间窗: First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.
To assess functional capacity, a simple exercise stress test will be performed following the recommendations of the Spanish Society of Cardiology in which the maximum oxygen consumption (VO2max). Ergometry, also known as stress test, is not only a diagnostic technique that analyzes the response of the heart to exercise, but also a test that is able to quantify the oxygen consumption of the individual who performs it. In this study it will be performed on a treadmill. The Bruce protocol will be used, which progressively increases the speed of the treadmill and its inclination every 3 minutes. It will be performed by a cardiologist of the unit. VO2max will be obtained in METS (a metabolic equivalent 1 MET = 3.5 ml O2/kg/min).
次要结局
- Eating habits(First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.)
- Maximum static quadriceps muscle strength(First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.)
- Hand grip strength(First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.)
- Incidents(During the intervention)
- The number of sessions(During intervention)
- The Charlson Comorbidity Index(Between recruitment and the start of intervention)
- Sleep Quality(First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.)
- Level of physical activity(First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.)
- The left ventricular ejection fraction (LVEF)(First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.)
- Maximal Inspiratory Pressure (MIP)(First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.MIP will be reassessed midway through the program to readjust the training load.)
- Maximal Expiratory Pressure (MEP)(First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.)
- Quality of life(First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.)
- Anxiety and Depression(First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.)
- Functional Social Support(First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.)
- Erectile Dysfunction(First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.)
- Dyspnea(First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.)
- Body Composition by Bioimpedance(First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.)
- Waist circumference(First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.)
- Nutritional Ultrasound(First measurement between recruitment and the beginning of the intervention, second measurement between the end of the intervention and 2 weeks after the intervention.)
研究者
Jose Maria Zuazagoitia de la Lama-noriega
University professor. Graduate in Physiotherapy. Master in New Trends in Health Sciences Research.
University of Cadiz