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临床试验/NCT01914094
NCT01914094已完成不适用

Pre-habilitation Program for Elective Coronary Artery Bypass Graft Surgery Patients

St. Boniface Hospital2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2011年2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
17
试验地点
2
主要终点
Change in 6-minute walking distance

研究概览

简要总结

Low levels of physical fitness increase the risk of death in patients with cardiovascular disease. Although cardiac rehabilitation programs improve the health of patients after heart surgery, most patients are not referred until after surgery. Therefore, the purpose of this study was to determine if an exercise "pre-habilitation" (i.e., Prehab) program before heart surgery would improve the health of patients before surgery and whether these improvements would be maintained after surgery.

The investigators hypothesized that Prehab would promote the health of patients before heart surgery, and these improvements would be maintained three months post-operatively, as compared to patients who received standard care.

详细描述

This was a single-centre, parallel randomized controlled trial conducted in Canada to determine the feasibility and efficacy of an exercise and education "pre-habilitation" (i.e., Prehab) program before elective coronary artery bypass graft surgery (CABG). We recruited 17 patients who were scheduled to undergo elective CABG surgery from February 2011-May 2012. Enrolled patients were assessed at baseline, one week pre-operatively, and three months post-operatively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • On elective waitlist for coronary artery bypass graft surgery with a minimum anticipated wait time of 4-6 weeks or more
  • No history of unstable angina
  • Canadian Cardiovascular Society score of less than 4
  • No history of myocardial infarction within the past 7 days
  • Ejection fraction greater than 30%
  • No history of dementia or psychiatric problems
  • No self-reported dizziness or confusion
  • Able to read, speak, and understand English
  • Previously sedentary (reporting accumulating less than 45 minutes of moderate intensity physical activity per day on at least three days per week over the last three months)
  • No previous participation in cardiac rehabilitation
  • Lives in Winnipeg, Manitoba, Canada or has easy access to the Reh-Fit Centre (local medical fitness facility)

排除标准

  • If patients cannot attend Prehab due to geographical limitations
  • If patients cannot participate due to physical limitations
  • Diagnosis of exercise-induced arrhythmia

结局指标

主要结局

Change in 6-minute walking distance

时间窗: Baseline; 1 week pre-operatively; 3 months post-operatively

Assessed using the 6-minute walking test. Output is distance. Change from baseline 6-minute walking distance was assessed at each follow-up time point.

次要结局

  • Change in depressive symptoms(Baseline; 1 week pre-operatively; 3 months post-operatively)
  • Change in 5-meter gait speed(Baseline; 1 week pre-operatively; 3 months post-operatively)
  • Change in objectively measured physical activity(Baseline; 1 week pre-operatively; 3 months post-operatively)
  • Change in quality of life(Baseline; 1 week pre-operatively; 3 months post-operatively)
  • Change in exercise self-efficacy(Baseline; 1 week pre-operatively; 3 months post-operatively)
  • Change in cardiac anxiety(Baseline; 1 week pre-operatively; 3 months post-operatively)

研究者

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

Dr. Rakesh C. Arora

Medical Director, Intensive Care Cardiac Sciences

St. Boniface Hospital

研究点 (2)

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