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临床试验/NCT02311738
NCT02311738Unknown不适用

The Effect of Exercise and Genes on Energy Expenditure, Appetite and Quality of Life in Morbidly Obese Patients

Jarle Berge12 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
12
主要终点
Energy expenditure during physical activity

研究概览

简要总结

Regular exercise has several positive health effects including increased physical fitness and muscle mass. It is well known that increased muscle mass is associated with increased resting energy expenditure which may facilitate weight loss and maintenance. Previous studies have, however, failed to show any consistent association between the intensity of physical exercise and energy expenditure, or relate the variance in these adaptations to genetic variability. Whether high-intensity exercise (HIE) is associated with improved health related quality of life in severely obese patients remains unknown.

This PhD-project is based on a planned randomised controlled study including 50 or more treatment seeking morbidly obese patients who will be randomised to either a 24 week moderate-intensity exercise (MIE) programme or a 24 week high-intensity exercise (HIE) programme. The investigators main hypothesis is that patients randomised to the HIE-program will achieve higher energy expenditure during rest and physical activity after treatment than those allocated to the MIE-programme. In addition, the investigators hypothesise that the HIE-group will achieve a better health related quality of life than the MIE-group after treatment. The investigators also hypothesize that inter-individual variability in adaptation to the two training regimens may be due to genetic factors. If the investigators hypotheses are confirmed, this project might have beneficial clinical implications for future obesity treatment strategies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Treatment seeking weight stable morbidly obese patients (BMI ≥ 40 kg/m2 or BMI 35 to 39.9 kg/m2 with ≥ 1 co morbidity) attending the outpatient Obesity Center, Vestfold Hospital Trust, will be informed about this RCT .

排除标准

  • Uncompensated heart failure
  • Recent myocardial infarction or stroke (<½ years)
  • Severe arrhythmia or heart failure
  • Unstable angina pectoris
  • Renal failure
  • Pregnancy
  • Severe eating disorders
  • Active substance abuse
  • Being on a diet
  • Taking medication known to affect appetite or metabolism (including thyroxin).

结局指标

主要结局

Energy expenditure during physical activity

时间窗: 0, 8, 12 and 24 weeks

Energy expenditure (EE) during volitional activity will be measured with ergo-spirometry tests one week before the exercise intervention period starts, and repeated after each exercise period. Increasing the aerobic work capacity is supposed to give the same proportional increase in energy expenditure at any given maximal intensity.

次要结局

  • Fat mass and fat free mass(0, 8, 12 and 24 weeks)
  • Binge Eating Scale (BES)(0,12 and 24 weeks)
  • Resting metabolic rate(0, 8, 12 and 24 weeks)
  • Cardiorespiratory fitness(0, 8, 12 and 24 weeks)
  • Body mass index(0, 8, 12 and 24 weeks)
  • Waist circumference(0, 8, 12 and 24 weeks)
  • Appetite control(0,12 and 24 weeks)
  • Body weight change(0, 8, 12 and 24 weeks)
  • Genetic susceptibility(0, 8, 12 and 24 weeks)
  • Impact on Weight Questionnaire (IWQOL-Lite)(0,12 and 24 weeks)
  • Short form health survey (RAND-36)(0,12 and 24 weeks)
  • Weight-Related Symptom Measure (WRSM)(0,12 and 24 weeks)
  • Power of Food scale (PFS)(0,12 and 24 weeks)
  • Three Factor Eating Questionnaire (TFEQ -R21)(0,12 and 24 weeks)

研究者

发起方
Jarle Berge
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jarle Berge

PhD-Fellow

Sykehuset i Vestfold HF

研究点 (12)

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