The Effect of Inspiratory Muscle Training and Respiratory Physiotherapy on Pulmonary Functions, Respiratory Muscle Strength and Functional Capacity in Patients With Robotic Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 4 weeks
研究概览
简要总结
During the past decade, especially with the advancement of technology, major innovations and developments have been observed in the field of surgery. Cardiac surgery is one of the important area of the surgery who renews itself day by day and adds innovations to the nature in terms of patients' comfort. One of the greatest developments in cardiac surgery in this sense is the tendency to reduce the size of the incisions with less interventional procedures. Robotic surgery is getting more and more meaningful in this area. Despite the downsizing of the surgical incisions, postoperative pulmonary complications have not completely disappeared in the robotic cardiac surgery. Major respiratory problems following traditional cardiac surgery are gas exchange problems, atelectasis, decreased coughing force and sputum retention. The effectiveness of respiratory physiotherapy applied after traditional cardiac surgery for the resolution of these complications has been proved by various investigations. Inspiratory muscle training (IMT) has been found to improve autonomic modulation in heart failure patients as well as to increase inspiratory muscle strength in applied patient populations, reduce blood pressure in hypertensive patients, and increase functional capacity in elderly individuals. Considering these benefits, when inspiratory muscle training is given to people with traditional cardiac surgery, respiratory muscle strengths, respiratory functions and functional capacities are increased compared to those not given to these patients. However, although there are complications after robotic cardiac surgery, there are no studies in the literature about respiratory physiotherapy or inspiratory muscle training. Thus, the subject of this study is the comparison of the effects of standard respiratory physiotherapy and standard respiratory physiotherapy plus inspiratory muscle training on the respiratory functions, respiratory muscle strength and functional capacity of the patients with the robotic heart surgery.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being suitable for robotic cardiac surgery,
- •Being hospitalized to have a robotic heart surgery,
- •No complications during surgery,
- •To be extubated in intensive care unite after surgery ,
- •Stable clinical condition,
- •To be transferred from ICU to the hospital room on the first day after surgery.
排除标准
- •Chronic obstructive pulmonary disease,
- •Unstable angina,
- •Acute decompensated heart failure,
- •Acute pericarditis and myocarditis,
- •Complex arrhythmia,
- •Uncontrolled hypertension,
- •Serious orthopedic and neurological impairment,
- •Uncontrolled diabetes,
- •Body Mass Index > 30.
研究组 & 干预措施
Control Group
Standard respiratory physiotherapy
Patients in this group will receive standard respiratory physiotherapy two times a day, 7 days a week for 4 weeks. During hospitalization, sessions will be performed by a respiratory physiotherapist. After discharge, other sessions will be performed at home by themselves.
干预措施: Standard respiratory physiotherapy (Other)
Training Group
Standard respiratory physiotherapy and inspiratory muscle train
In addition to the standard respiratory physiotherapy program, patients in this group will receive 3 sets of inspiratory muscle training with 10 repetitions twice a day for 4 weeks. During hospitalization, sessions will be performed by a respiratory physiotherapist. After discharge, other sessions will be performed at home by themselves.
干预措施: Standard respiratory physiotherapy and inspiratory muscle training (Other)
结局指标
主要结局
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 4 weeks
时间窗: Four weeks
Change from baseline carbon monoxide diffusion capacity of the lungs (DLCO) at 4 weeks
时间窗: Four weeks
Change from baseline Forced Vital Capacity (FVC) at 4 weeks
时间窗: Four weeks
Change from baseline maximum inspiratory pressure (MIP) at 4 weeks
时间窗: Four weeks
Change from baseline maximum expiratory pressure (MEP) at 4 weeks
时间窗: Four weeks
Change from baseline distance covered in six-minute walk test (6MWT) at 4 weeks
时间窗: Four weeks
Change from baseline Peak Expiratory Flow (PEF) at 4 weeks
时间窗: Four weeks
次要结局
- Fatigue Severity Scale(Four weeks)
- Fatigue Impact Scale(Four weeks)
研究者
Aslı İrem Dönmez
PT, Research Assistant at Faculty of Health Sciences, Acibadem University
Acibadem University
