跳至主要内容
临床试验/NCT01356264
NCT01356264已完成2 期

Multimodal Prehabilitation to Enhance Functional Recovery After Colorectal Surgery: a Randomized Controlled Trial

McGill University Health Centre/Research Institute of the McGill University Health Centre2 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2011年7月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
89
试验地点
2
主要终点
six minute walk test

研究概览

简要总结

Despite advances in surgical care, the incidence of postoperative complications and prolonged recovery following colorectal surgery remains high. Efforts to improve the recovery process have primarily focused on the intraoperative (eg, minimally invasive surgery, afferent neural blockade) and post-operative periods (eg, "fast track" early nutrition and mobilization. The pre-operative period may in fact be a better time to intervene in the factors that contribute to recovery. The process of enhancing functional capacity of the individual in anticipation of an upcoming stressor has been termed "prehabilitation". Based on the notion that preoperative exercise would have an impact on recovery of functional capacity after colorectal surgery, our group recently conducted a randomized controlled trial. Subgroup analysis identified that patients whose functional exercise capacity improved preoperatively, regardless of exercise technique, recovered well in the postoperative period. However, one-third of patients deteriorated preoperatively despite the exercise regimen, and these patients were also at greater risk for prolonged recovery after surgery. These results suggested that exercise alone is not sufficient to attenuate the stress response in all patients. In the present trial, the impact of a multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being begun in the preoperative period will be compared to one begun in the postoperative period.

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
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • referred for scheduled surgery for nonmetastasized colorectal cancer
  • age > 18 years old

排除标准

  • Poor English or French comprehension
  • severe co-morbid disease interfering with ability to perform exercise at home or complete testing

结局指标

主要结局

six minute walk test

时间窗: baseline, preop, 4 weeks, 8weeks postop

6 MWT is a patient-relevant measure of functional walking capacity, reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk. The distance in meters is recorded. Reference equations are available for calculating percent of age- and gender-specific norms.

次要结局

  • Health-related quality of life(baseline, preop, 4 weeks, 8 weeks)
  • physical activity level(baseline, preop, 4 weeks, 8 weeks)
  • Depression and anxiety(baseline, preop, 4 weeks, 8 weeks)
  • nutritional status(baseline, preop, 4 weeks, 8 weeks)
  • postoperative complications(4 weeks)
  • Fatigue(baseline, preop, 4 wks, 8 wks)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Liane S. Feldman

MD

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (2)

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