The Effects of Peripheral and Respiratory Muscle Training in Coronary Artery Patients With Metabolic Syndrome: A Randomized, Prospective, Double-Blind and Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Maximum Inspiratory Pressure (MIP)
研究概览
简要总结
The aim of this study is to investigate the effects of peripheral and respiratory muscle training on respiratory muscle strength, respiratory functions, exercise capacity and quality of life in coronary artery patients with metabolic syndrome. Prospectively, randomly, double-blind, and controlled study. Stable coronary artery patients with metabolic syndrome will be included to the study from the Istanbul University Cardiology Institute clinic. Patients will be randomized into 3 groups; Neuromuscular Electrical Stimulation (NMES) and Peripheral Muscle Training Group (n: 20): 3 days per week for 6 weeks duration. Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation three times per week for 6 weeks.Inspirator Muscle Training (IMT) and peripheral muscle training Group (n: 20): IMT will be applied 7 days per week, twice a day for 15 minutes. The program will continue for 6 weeks duration under weekly control of the investigator. Training intensity will set at 30% of the maximum inspiratory pressure.Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation three times per week for 6 weeks. Peripheral Muscle Training Group (n: 20): Exercise will be applied by elastic band and Proprioceptive Neuromuscular Facilitation three times per week for 6 weeks.Parameters will be recorded before and after training. Evaluation parameters:Demographic and anthropometric measurements, respiratory function test,respiratory muscle strength,dyspnea, peripheral muscle strength, 6 minutes walking test, physical activity, quality of life, depression, sleep quality and laboratory evaluation.
详细描述
Metabolic syndrome (MS) is a fatal endocrinopathy that appears with insulin resistance and is associated with systemic disorders such as abdominal obesity, glucose intolerance or diabetes mellitus, dyslipidemia, hypertension and coronary artery disease (CAD). The metabolic syndrome, which is regarded as an important public health problem in the world, shows a global increase.
Studies have showed that increased risk for cardiopulmonary disease is associated with people with metabolic syndrome. In the treatment of cardiopulmonary risk factors, therapeutic lifestyle changes and exercise are recommended in primary care strategy. Exercise training programs have been found to have positive effects on cardiopulmonary and metabolic parameters.It has been shown that respiratory functions are also adversely affected in these patients. In patients with metabolic syndrome, FEV1 and FVC were found to be influenced by decreased respiratory function and restrictive ventilation impairment.
Decreased respiratory functions and physical activity in patients with Metabolic Syndrome accompanied by multifactorial risks and complications will adversely affect quality of life. There are no studies in the literature that investigate the effects of peripheral and respiratory muscle training in patients with Metabolic Syndrome. Therefore, we aimed to investigate the effect of peripheral and respiratory muscle training on respiratory muscle strength, respiratory functions, exercise capacity and quality of life in patients with Metabolic Syndrome. This study also aimed to contribute to the international literature by applying respiratory muscle training in patients with coronary artery disease with metabolic syndrome. In addition, in clinically structured rehabilitation programs, in coronary artery disease patients with metabolic syndrome will be provided with a questioning of the importance of respiratory muscle training.
The study will be planned as prospective, randomized, double blind and controlled. Access to the patients will be provided through an archive of patient records and a screening through the online system of the outpatient clinic. Before and after the training patients' effort tests and biochemical tests will be requested. Evaluations before and after the training will be done by another physiotherapist. The study will be conducted prospectively, randomly, double-blind, and controlled. Patients will be randomized into 3 groups.
NMES and Peripheral Muscle Training Group (n: 20).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable coronary artery disease with metabolic syndrome diagnosis
- •The ejection fraction(EF) = % 40 and EF >% 40,
- •Participation to the study will be in a voluntary basis
排除标准
- •Over 80 years,
- •EF <40% or New York Heart Association (NYHA) class III-IV
- •Chronic obstructive pulmonary disease (COPD) and respiratory tract infection,
- •Documented diagnosis of pulmonary, neurological,orthopedic, renal, hepatic, gastrointestinal, endocrine, oncologic
- •New or suspected thromboembolic events
- •Severe refractory hypertension
- •Acute myocardial infarction and pulmonary edema in the last 6 months,
- •Coronary artery revascularization attempts (percutaneous transluminal coronary angioplasty and coronary artery bypass surgery) and previous valve surgery in the last 6 months,
- •Cardiac pacemaker
研究组 & 干预措施
NMES and Peripheral Muscle Training
Neuromuscular Electrical Stimulation (NMES) and Peripheral Muscle Training
NMES frequency will be 30 Hertz and the application time will be 30 minutes.Treatment will be programmed for 3 days per week.
Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation 3 times per week.The program will continue for 6 weeks.
干预措施: Neuromuscular Electrical Stimulation (Device)
NMES and Peripheral Muscle Training
Neuromuscular Electrical Stimulation (NMES) and Peripheral Muscle Training
NMES frequency will be 30 Hertz and the application time will be 30 minutes.Treatment will be programmed for 3 days per week.
Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation 3 times per week.The program will continue for 6 weeks.
干预措施: Peripheral Muscle Training (Other)
IMT and Peripheral Muscle Training
Inspirator Muscle Training (IMT) and Peripheral Muscle Training
IMT will be applied 7 days per week, twice a day for 15 minutes.
Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation 3 times per week. The program will continue for 6 weeks.
干预措施: Inspirator Muscle Training (Other)
IMT and Peripheral Muscle Training
Inspirator Muscle Training (IMT) and Peripheral Muscle Training
IMT will be applied 7 days per week, twice a day for 15 minutes.
Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation 3 times per week. The program will continue for 6 weeks.
干预措施: Peripheral Muscle Training (Other)
Peripheral Muscle Training
Peripheral Muscle Training
Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation 3 times per week.The program will continue for 6 weeks.
干预措施: Peripheral Muscle Training (Other)
结局指标
主要结局
Maximum Inspiratory Pressure (MIP)
时间窗: Baseline and 6 weeks
Change from baseline Maximum Inspiratory Pressure (MIP) at 6 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The most commonly used method for evaluating respiratory muscles is MIP measurement is a non-invasive technique.
Maximum Expiratory Pressure (MEP)
时间窗: Baseline and 6 weeks
Change from baseline Maximum Expiratory Pressure (MEP) at 6 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The most commonly used method for evaluating respiratory muscles is MEP measurement is a non-invasive technique.
Functional capacity
时间窗: Baseline and 6 weeks
Change from baseline functional capacity test at 6 weeks. Functional capacity will be assessed by the 6 minute walking test. The test will be performed according to American Thoracic Society (ATS) criteria. Patients will be allowed to rest for 10 minutes before the test. Heart rate, blood pressure, respiratory frequency, oxygen saturation, fatigue and dyspnea perception will be recorded before and after the test. Walking distance will be calculated.
次要结局
- Forced Vital Capacity (FVC)(Baseline and 6 weeks)
- Peak flow rate (PEF)(Baseline and 6 weeks)
- Dyspnea(Baseline and 6 weeks)
- Anthropometric measurements(Baseline and 6 weeks)
- Evaluation of Low Density Lipoprotein in blood biochemistry(Baseline and 6 weeks)
- Forced Expiratory Volume 1 second / Forced Vital Capacity (FEV1 / FVC)(Baseline and 6 weeks)
- Maximal exercise capacity(Baseline and 6 weeks)
- Evaluation of fasting blood glucose in blood biochemistry(Baseline and 6 weeks)
- Quality of life level(Baseline and 6 weeks)
- Forced Expiratory Volume 1 second (FEV1)(Baseline and 6 weeks)
- Forced Expiratory flow from between 25% to 75% of Vital Capacity (FMF 25-75)(Baseline and 6 weeks)
- Depression level(Baseline and 6 weeks)
- Evaluation of Brain Natriuretic Peptide (Pro-BNP) in blood biochemistry(Baseline and 6 weeks)
- Peripheral muscle strength(Baseline and 6 weeks)
- Physical Activity(Baseline and 6 weeks)
- Evaluation of sleep quality(Baseline and 6 weeks)
- Evaluation of High Density Lipoprotein in blood biochemistry(Baseline and 6 weeks)
- Evaluation of triglyceride in blood biochemistry(Baseline and 6 weeks)
- Evaluation of Antistreptolysin O (ASO) in blood biochemistry(Baseline and 6 weeks)
- Evaluation of C-Reactive Protein (CRP) in blood biochemistry(Baseline and 6 weeks)
- Evaluation of sedimentation in blood biochemistry(Baseline and 6 weeks)
- Evaluation of complete blood count in blood biochemistry(Baseline and 6 weeks)
- Evaluation of Creatine phosphokinase (CPK) in blood biochemistry(Baseline and 6 weeks)
- Evaluation of Thyroid-Stimulating Hormone (TSH) in blood biochemistry(Baseline and 6 weeks)
- Evaluation of ferritin in blood biochemistry(Baseline and 6 weeks)
- Evaluation of creatinine in blood biochemistry(Baseline and 6 weeks)
- Evaluation of uric acid in blood biochemistry(Baseline and 6 weeks)
研究者
Kıymet Muammer, MSc PT
Principal Investigator
Istanbul Medipol University Hospital