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临床试验/NCT02367742
NCT02367742已完成不适用

Effect of Two Different Programs of Physical Activity on the Grade of Severity of NAFLD

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis0 个研究点目标入组 100 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
主要终点
Change from Baseline in NAFLD score at three and six months

研究概览

简要总结

It has been demonstrated the essential role of physical activity in the prevention of overweight and obesity. Nevertheless, the effect of a program of physical activity on the maintenance of body weight in subjects who have previously followed a dietary intervention is still unknown. The aim of this study was to investigate this topic by evaluating the effect of two different programs of physical activity on subjects who have followed a dietary intervention but presented again NAFLD a year after the treatment.

详细描述

Subjects who were previously enrolled in the trial NUTRIEP and who still have NAFLD a year after the end of the study, were invited to participate in a program of physical activity to assess the effect of endurance and resistance training on weight and NAFLD score. Participants (100 subjects) were randomized and divided into two groups: the first followed a program of endurance activity consisting in a 30 minute walk, 5 times/week; the second followed a program combining the just described aerobic exercise with a resistance training based on 30 minute of musculation involving all the bigger muscles, 3 times/week. The trial lasted six months and subjects underwent liver ultrasonography (to assess NAFLD score), indirect calorimetry, bioimpedenziometry, the measurement of anthropometric variables (body height and weight) and biological parameters (glucose, insulin, cholesterol, HDL cholesterol, triglycerides, GOT, GPT and GGT) at the baseline and at the third and the sixth month. The aim of the study was to estimate the effect of the two different programs of physical activity on NAFLD score. Secondary end-points included: the effect on basal metabolism, the modification of fat mass (FM), lean mass (LM) and muscle mass (MM) and on several biological markers associated with NAFLD.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Moderate or severe NAFLD
  • Enrolled in the previous trial called NUTRIEP

排除标准

  • Not enrolled in the previous trial called NUTRIEP

结局指标

主要结局

Change from Baseline in NAFLD score at three and six months

时间窗: Six months

次要结局

  • Change from Baseline in Indirect calorimetry at three and six months(Six months)
  • Percentage Change from Baseline in Bioimpedenziometry at three and six months(Six months)

研究者

发起方
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alberto R Osella

MD, PhD

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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