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临床试验/NCT01100450
NCT01100450已完成不适用

Pilot Study to Determine Feasibility, Acceptance, and Efficacy of a 12-week Progressive Resistance Training Exercise Protocol in Patients With Class III Obesity Preparing for Bariatric Surgery.

Beth Israel Deaconess Medical Center4 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2009年9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
6
试验地点
4
主要终点
6-Minute Walk Test

研究概览

简要总结

To test the strength and physical performance outcomes of a 12-week progressive resistance training (PRT) exercise program in a small cohort of patients with Class III obesity who are preparing for bariatric weight loss surgery at Beth Israel Deaconess. The study will also test patient compliance to the 12 week PRT program. Whereas PRT exercise is currently recommended as a part of preoperative clinical care for bariatric surgery patients, little research has been done to measure the acceptance and effectiveness of a standardized PRT exercise protocol for improving health and perioperative care. Preliminary data from this study could be used to justify larger studies and further investigation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women 18-65 years old
  • A BMI of ≥40 kg/m2
  • Considering Weight Loss Surgery at BIDMC
  • Participating in multidisciplinary preoperative program:
  • been determined by a mental health professional (i.e., psychologist or social worker) to be well-informed, motivated, and not symptomatic for psychopathology that would put the person at risk for injury or failure with WLS
  • expressed strong desire for significant weight loss
  • experienced documented failure of long-term weight loss using nonsurgical methods
  • been informed of and accepts risks of surgery
  • Cleared by their primary care physician to be in stable health and capable of moderate level exercise
  • Willing to comply with expected attendance and participation at all intervention sessions and testing appointments
  • Has reliable transportation to the intervention location

排除标准

  • Orthopedic limitations that would preclude exercise testing and training

结局指标

主要结局

6-Minute Walk Test

时间窗: After training - Week 12

Subjects are instructed to walk from one end to the other of a 30- meter hallway at their own pace, while attempting to cover as much ground as possible in the allotted 6 minutes. Subjects are allowed to stop and rest during the test, but were instructed to resume walking as soon as they felt able to do so. Total distance walked was recorded at the end of the test.

次要结局

  • Muscle Fatigability Test(After training-Week 12)
  • 1-repetition maximum muscle strength test(After training - Week 12)

研究者

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

Miguel Alonso-Alonso, MD

Assistant Professor of Surgery

Beth Israel Deaconess Medical Center

研究点 (4)

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