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临床试验/NCT00793832
NCT00793832已完成不适用

The Effect of Supervised Cardiorespiratory Endurance Exercise Training on Physical Fitness and Energy Expenditure in Roun-en-Y Gastric Bypass and Gastric Banding Surgery Patients.

University of Texas Southwestern Medical Center0 个研究点目标入组 33 人开始时间: 2007年7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
33
主要终点
Exercise at a level sufficient to accumulate at least 2000kcal per week

研究概览

简要总结

It is hypothesized that the patients in the EXDA group will be able to complete a structured exercise program at a level sufficient to accumulate at least 2000 kcal per week, and that the structured endurance activity will increase their physical fitness and total daily energy expenditure compared to the DA group.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • RYGB or GB surgery patients who are at least 12 weeks post surgery
  • BMI of 40 or more
  • age 18-70years
  • sedentary lifestyle (energy expenditure of <35 kcal/kg/day measured by 7-day physical activity recall and no regular moderate physical activity exceeding 20 min/day within the previous 3 months)
  • willingness to alter physical activity in accordance with the intervention programs
  • English or Spanish speaking.

排除标准

  • body weight > 180 kg
  • cardiovascular disease
  • pulmonary disease
  • uncontrolled hypertension (resting DBP >100 or SBP >180 mm of Hg)
  • visual or hearing impairment
  • functional limitations (difficulty walking one-quarter mile or climbing 10 stairs)
  • abnormal ECG on VO2max test ( >1 mm ST segment depression at < 5 METS or with symptoms such as atrial fibrillation, complex ventricular arrhythmias and 3rd degree atrioventricular block)
  • known liver disease due to causes other than nonalcoholic steatohepatitis (liver transaminases > 2.5 times the upper limits of normal [SGPT>105 U/L, SGPT>120 U/L] or total bilirubin >1.5 mg/dL)
  • hematocrit of less than 30%
  • current alcohol abuse (>7 drinks or 210 g/wk for women and >14 drinks or 420 g/wk for men)
  • recreational drug abuse
  • current use of any drugs capable of inducing weight loss (e.g., orlistat, sibutramine, topiramate, etc.)
  • major neuro-psychiatric illnesses impeding competence or compliance
  • pregnancy and lactation
  • chronic renal insufficiency (serum creatinine > 2 mg/dL)
  • untreated thyroid disorders such as hypothyroidism and hyperthyroidism; and 17) bariatric surgical complications including anastomotic leak, wound complications, thrombotic disorders, intestinal obstruction, stomal complications, GI bleeding, recurrent severe abdominal pain, bilious vomiting.

结局指标

主要结局

Exercise at a level sufficient to accumulate at least 2000kcal per week

时间窗: 12 weeks

次要结局

  • To compare body weight and composition, quality of life, fasting lipids and lipoproteins, and glycemic control between the two groups.(12 weeks)

研究者

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

Abhimanyu Garg

Professor

University of Texas Southwestern Medical Center

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