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临床试验/NCT02437240
NCT02437240Unknown不适用

Effects of Pilates-based Cardiopulmonary Physical Therapy for In-Patients After Cardiac Surgery

National Yang Ming Chiao Tung University0 个研究点目标入组 140 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
140
主要终点
change from pre-operation in respiratory mechanics

研究概览

简要总结

The purpose of this clinical trial is to evaluate the effect of pilates-based cardiopulmonary physical therapy (CPT) for in-patients after cardiac surgery.

详细描述

Postoperative pulmonary and musculoskeletal complications are the most frequent and significant contributor to morbidity, mortality with hospitalization. Pilates-based exercise has be applied to improve core control, movement efficiency and postural stability. High incidence of musculoskeletal problems have been concerned in relation to the patient's functional recovery after cardiac surgery. However, no literature is addressed how to manage this issue effectively till now. The purpose of this clinical trial is to evaluate the effect of pilates-based cardiopulmonary physical therapy for in-patients after cardiac surgery. This is a single-blinded, randomized control trial. Investigators will enroll pre-cardiac surgery and allocate subjects to modified Pilates-based training group or control group using block randomization.The training protocol will be based on pilates concepts. The control group is treated with a conventional protocol of physical therapy. The study will be carried on whole in-patient phase. During this period, patients received respiratory motion analysis, chest wall muscles mobility, lung function and endurance evaluation. Patients' changes in respiratory movement, cardiopulmonary endurance, and lung function will be evaluated by an assessor blinded to the intervention at admission and discharge from hospital. After 6 months after hospital discharge, patient's respiratory motion, lung function and disease specific health related quality of life will be evaluated. All outcomes will be described by mean (SD) or number (%). Independent t test or chi square test will be used to compare the basic data difference between training group and conventional group. Then, two-way analysis of variance or two-way analysis of covariance will be used to compare the outcomes difference between groups. Alpha level is set at 0.05.

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 (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • post open heart surgery
  • FVC> 80% of predicted and/or FEV1>70% of predicted
  • age >/=20 years old
  • approve inform consent

排除标准

  • preoperative severe pulmonary hypertension
  • moderate to severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease
  • heart failure or s/p heart transplant
  • emergent surgery

结局指标

主要结局

change from pre-operation in respiratory mechanics

时间窗: at hospital discharge, an expected average of 2 weeks after surgery

Chest motion in deep breathing will be assessed simultaneously by 3D reality motion analysis and spirometer. Participants will be followed at hospital discharge, an expected average of 2 weeks after surgery.

次要结局

  • change from pre-operation in respiratory mechanics(at 6 month after surgery)
  • change of cardiopulmonary fitness(at hospital discharge, an expected average of 2 weeks after cardiac surgery)
  • health related quality of life(at 6 month after hospital discharge)
  • cardiopulmonary exercise function(at one month after hospital discharge)
  • change from pre-operation in chest mobility(at hospital discharge, an expected average of 2 weeks after surgery)
  • abnormal breathing pattern(at 6 month after surgery)
  • Percentage change from preoperative pulmonary function(at 6 month after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mei-Wun Tsai

Associate Professor

National Yang Ming Chiao Tung University

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