Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Maximum inspiratory pressure
研究概览
简要总结
A review of the literature suggests that high-intensity intermittent inspiratory muscle training (IMT) combined with the Otago exercise program may provide positive effects on early post-discharge recovery of patients aged 65 years and older undergoing coronary artery bypass graft (CABG) surgery. No studies have yet examined the effects of high-intensity intermittent IMT combined with the Otago exercise program on patients undergoing CABG surgery. This study is the first to evaluate the effects of high-intensity intermittent IMT combined with the Otago exercise program on pulmonary function, functional capacity, muscle strength, functional mobility, balance, anxiety and depression levels, frailty, and quality of life in elderly patients undergoing CABG surgery.
详细描述
Coronary artery bypass graft (CABG) surgery aims to revascularize the myocardium by bypassing one or more coronary arteries narrowed or occluded due to atherosclerosis. Procedures such as sternotomy, cardiopulmonary bypass, general anesthesia, and pleural drain placement can lead to postoperative complications including hypersecretion, hypoxemia, decreased pulmonary compliance, reduced exercise capacity, and impaired lung function. These complications may cause prolonged immobilization and additional pulmonary issues. Moreover, protein catabolism after cardiovascular surgery leads to muscle protein loss, which is exacerbated by immobilization, slowing protein synthesis and accelerating muscle fiber breakdown and cell death, thereby contributing to muscle loss progression. Postural balance also decreases following CABG, potentially leading to reduced functional activities, increased fall risk, morbidity, and mortality. CABG negatively impacts patients' quality of life and causes functional limitations. Anxiety about disease recurrence and fear of death after discharge contribute to psychological stress for patients and relatives, further impairing recovery.
Frailty is closely associated with cardiopulmonary diseases and is common after CABG surgery. A study evaluating 180 bypass patients with an average age of approximately 69 years found that 23.3% were frail. High frailty scores post-CABG correlate with adverse outcomes such as prolonged hospital stays and rehospitalization within 30 days.
Inspiratory muscle training (IMT) is a method designed to strengthen inspiratory muscles by providing airway resistance during breathing. Effective IMT requires appropriate intensity, duration, and frequency. Training at or above 30% of maximal inspiratory pressure (MIP) for 20-30 minutes daily, five days a week, over 5-12 weeks produces structural changes in respiratory muscles.
Previous studies demonstrated that IMT improves inspiratory muscle strength, functional capacity, psychosocial status, and quality of life in patients undergoing CABG surgery. Additionally, moderate to high-intensity IMT combined with aerobic and strengthening exercises during cardiac rehabilitation increases exercise capacity, inspiratory muscle strength, and quality of life more than sham IMT combined with similar exercises.
High-intensity intermittent IMT has recently shown beneficial results in cardiovascular and pulmonary diseases. In heart failure patients, high-intensity intermittent IMT performed in cycles of loading and rest improved dyspnea, frailty, fatigue, inspiratory muscle strength, respiratory muscle endurance, exercise capacity, and quality of life, compared to sham IMT. Similar positive effects were observed in patients with bronchiectasis and elderly individuals undergoing home-based IMT, with improvements in inspiratory muscle function, balance, and physical performance.
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 (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years and older undergoing coronary artery bypass graft surgery
- •Hospital discharge realized (post operative ≥ 2 weeks)
- •No contraindications for exercise training
- •Not concurrently participating in another exercise training program
- •Have the means to enter a home-based rehabilitation program
- •Patients who agree to participate voluntarily will be included in the study program.
排除标准
- •Cardiovascular instability (aortic dissection, unstable angina pectoris, acute decompensated heart failure, acute pericarditis or myocarditis, severe cardiac arrhythmia, ventricular aneurysm)
- •Uncontrolled hypertension and diabetes mellitus
- •Diagnosed with chronic lung disease
- •Cognitive impairment that prevents them from communicating with the physiotherapist
- •Failure to maintain the exercise training program
- •Patients with severe orthopedic or neurological disorders will not be included.
研究组 & 干预措施
Sham IMT and Otago Exercises Group
Patients aged 65 years and over who have undergone CABG surgery and who are at least 2 weeks postoperatively and who meet the inclusion criteria will be identified. Then, patients who volunteer to participate in the study will be referred.
干预措施: Sham IMT and Otago Exercises Group (Other)
High-intensity intermittent IMT and Otago Exercises Group
Patients aged 65 years and over who have undergone CABG surgery and who are at least 2 weeks postoperatively and who meet the inclusion criteria will be identified. Then, patients who volunteer to participate in the study will be referred.
干预措施: High-intensity intermittent IMT and Otago Exercises Group (Other)
结局指标
主要结局
Maximum inspiratory pressure
时间窗: The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.
In the maximum inspiratory pressure measurement, patients will be asked to perform maximum inspiration for at least 2 seconds through the mouthpiece after first performing maximum expiration by sitting and using a nose clip. The measurement result will be recorded in units of cmH2O and percentage % of the expected value. The measurement will be considered satisfactory when a change of less than 10% is observed between the three measurements and the highest value is adopted.
次要结局
- Maximum expiratory pressure(The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.)
- Forced vital capacity (FVC) massessment(The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.)
- Assessment of functional capacity(The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.)
- Evaluation of muscle strength(The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.)
- Assessment of functional mobility(The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.)
- Balance assessment(The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.)
- Assessment of anxiety and depression level(The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.)
- Frailty assessment(The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.)
- Assessment of quality of life(The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.)
- Forced expiratory volume in one second (FEV1) assessment(The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.)
- FEV1/FVC ratio(The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.)
- Forced expiratory flow 25-75% (FEF25-75) assessment(The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.)
- Peak expiratory flow (PEF) assessment(The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.)
研究者
Sadık Emre ÇELEBİ
MSc, PhD(c), Physiotherapist
Istanbul University - Cerrahpasa