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临床试验/NCT05188352
NCT05188352已完成不适用

Effects of Supervised Aerobic Exercise Training on Respiratory Parameters, Exercise Capacity, and Anxiety in Patients With Coronary Artery Bypass Surgery

Bezmialem Vakif University0 个研究点目标入组 30 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
主要终点
Change from baseline maximum inspiratory pressure at 8 weeks.

研究概览

简要总结

Based on clinical experience both physical condition and psychological recovery after surgery are individually variable. Exercise training plays an important part, has been recommended for CABS patients in order to enhance recovery. Regular exercise following CABS has shown that, in addition to the expected improvements in exercise capacity as a result of the surgery itself, patients who participate in cardiac rehabilitation can expect to see additional gains in exercise capacity and risk factor profiles. Exercise training also increases personal self-esteem and self-confidence, can alleviate depression and fear, and increase the sense of well-being. The aim of this study was to examine the effects of supervised aerobic exercise training on pulmonary function, functional capacity, maximal exercise capacity, and anxiety in patients after coronary artery bypass surgery.

详细描述

Patients in the training group received supervised aerobic exercise training on the treadmill with the intensity of 60-75% of maximal VO2 for 40-50 minutes, 3 days a week for 8 weeks in a cardiac rehabilitation unit. Work-load was gradually increased during eight-week period. Each session had a five-minute warm-up and cool-down period. Blood pressure and ECG were recorded during training sessions before exercise, at the third minute of each workload, after exercise, and during each minute of the recovery period. In addition, conventional chest physiotherapy and was instructed to continue their daily physical activity program at home patients in this group Patients in the control group received no aerobic exercise training but were asked to continue their chest physiotherapy and daily physical activity program at home.

The same researcher, who was blind to the group allocation, were evaluated all patients for pulmonary functions, respiratory muscle strength and submaximal functional capacity, exercise capacity, and anxiety level initially and after 8 weeks.

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 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male gender,
  • CABG surgery performed in the last one month,
  • Patients with negative exercise test (on the 30 days after discharge).

排除标准

  • Valve surgery,
  • Perioperative myocardial infarction assessed by electrocardiographic (ECG) and creatine kinase isoenzyme changes,
  • Postoperative angina, diabetes mellitus, chronic renal failure, unstable angina, intermittent claudication, heart valve dysfunction (moderate or severe), severe cardiac arrhythmias, -Presence of symptoms at rest or with minimal exertion,
  • Chronic obstructive pulmonary disease (>70% FEV1/FVC), and
  • Any disorder that might influence exercise performance physically (e.g. severe back pain, history stroke).

结局指标

主要结局

Change from baseline maximum inspiratory pressure at 8 weeks.

时间窗: [ Time Frame: Eight weeks ]

Change from baseline Maximum Inspiratory Pressure (MIP) at 8 weeks. Respiratory muscle strength was 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.

Change from baseline maximum expiratory pressure at 8 weeks

时间窗: [ Time Frame: Eight weeks ]

Change from baseline Maximum Expiratory Pressure (MEP) at 8 weeks. Respiratory muscle strength was 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.

Maximal exercise capacity

时间窗: [ Time Frame: Eight weeks ]

The incremantal, symptom-limited cardiopulmonary exercise test (CPET) was used to assess exercise capacity. Symptom-limited maximal exercise test with oxygen consumption measurement (peak VO2) (Minjhard Oxycon-3) on the treadmill using a Modified Bruce protocol.

次要结局

  • Change from baseline distance covered in six-minute walk test at 8 weeks.([ Time Frame: Eight weeks ])
  • Change from baseline Forced Vital Capacity (FVC) at 8 weeks([ Time Frame: Eight weeks ])
  • Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks .([ Time Frame: Eight weeks ])
  • Change from baseline anxiety level at 8 weeks.([ Time Frame: Eight weeks ])
  • Change from baseline maximal respiratory minute volume (VE), level at 8 weeks([ Time Frame: Eight weeks ])
  • Change from baseline VO2max/kg level at 8 weeks([ Time Frame: Eight weeks ])
  • Change from baseline maximal oxygen pulse (O2pulse) level at 8 weeks([ Time Frame: Eight weeks ])
  • Change from baseline maximal oxygen consumption(VO2max) level at 8 weeks([ Time Frame: Eight weeks ])
  • Change from baseline maximal MET level at 8 weeks([ Time Frame: Eight weeks ])
  • Change from baseline Forced Expiratory flow from between 25% to 75% of Vital Capacity at 8 weeks.([ Time Frame: Eight weeks ])

研究者

申办方类型
Other
责任方
Sponsor

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