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临床试验/NCT06800872
NCT06800872招募中不适用

Effect of Body Vibration Sessions on Energy Expenditure at Rest and on Cardiovascular and Musculoskeletal Parameters in Obese Boys Hospitalized for a Multidisciplinary Program of Integrated Metabolic Rehabilitation

Istituto Auxologico Italiano1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年7月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
28
试验地点
1
主要终点
Resting energy expenditure

研究概览

简要总结

The main aim of the present study is to evaluate in a group of adolescents with obesity, hospitalized for a period of integrated metabolic rehabilitation (calorie restriction, aerobic physical activity, psychological counseling, nutritional re-education) lasting 3 weeks, the effects produced from a period of training with vibration stimulation on vibration platforms (Whole Body Vibration Exercise [WBVE]) on the resting energy expenditure (REE), assessed through indirect calorimetry. The results will be compared with those obtained in a control group, subjected to integrated metabolic rehabilitation alone.

Secondary aims of the study are to evaluate the effects of training with WBVE also on cardiovascular and musculoskeletal parameters, evaluated through specific functional tests, comparing them with those obtained in the control group.

详细描述

The main aim of the present study is to evaluate in a group of adolescents with obesity, hospitalized for a period of integrated metabolic rehabilitation (calorie restriction, aerobic physical activity, psychological counseling, nutritional re-education) lasting 3 weeks, the effects produced from a period of training with vibration stimulation on vibration platforms (Whole Body Vibration Exercise [WBVE]) on the resting energy expenditure (REE), assessed through indirect calorimetry. The results will be compared with those obtained in a control group, subjected to integrated metabolic rehabilitation alone.

Secondary aims of the study are to evaluate the effects of training with WBVE also on cardiovascular and musculoskeletal parameters, evaluated through specific functional tests, comparing them with those obtained in the control 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
13 Years 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Age range 13-18 years
  • •Obesity (Body Mass Index Standard Deviation Score > 2)
  • •Hospitalization for a multidisciplinary program of integrated metabolic rehabilitation at the Division of Auxology, S. Giuseppe Hospital, Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy

排除标准

  • •Presence of cardiovascular, psychiatric, and musculoskeletal pathologies
  • •Absence of signed written consent

研究组 & 干预措施

Control group

Experimental

14 boys with obesity: standard in-hospital protocol of multidisciplinary metabolic rehabilitation

干预措施: Multidisciplinary metabolic rehabilitation (Other)

Experimental group

Experimental

14 boys with obesity: standard in-hospital protocol of multidisciplinary metabolic rehabilitation + 24 sessions (2 sessions per day) of 30 minutes each of training on a vibration platform.

干预措施: Multidisciplinary metabolic rehabilitation + training with WBVE (Other)

结局指标

主要结局

Resting energy expenditure

时间窗: At baseline and after 3 weeks

Resting energy expenditure assessed through indirect calorimetry.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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