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临床试验/NCT04508218
NCT04508218已完成不适用

Impact of Adding Protein Supplementation to Exercise Training on Lean Body Mass and Muscle Strength in Burn Patients

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
lean body mass

研究概览

简要总结

Burn injury causes continuous catabolism of the skeletal muscle resulting in decreased muscle strength, muscle mass and impairment of functional mobility. Purpose: The purpose of this study is to investigate the efficacy of combination of exercise training and protein supplementation on lean body mass (LBM) and muscle strength in patients with severe burn.

详细描述

Sixty participants with severe burn > 30% total body surface area (TBSA) were randomly distributed into 4 equal groups of 15 participants per group. Group A (Protein+ Exercise group) received oral protein supplementation, exercise program and traditional burn care, group B (Protein group) received oral protein supplementation and traditional burn care, group C (Exercise group) received exercise program and traditional burn care, group D (Control group) received traditional burn care. LBM was measured using Dual-energy x-ray absorptiometry (DXA) while muscle strength was measured using Biodex 3 Dynamometer System before treatment and 12 weeks after treatment.

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 (Participant)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •healed deep partial-thickness thermal burn
  • •> 30% of TBSA and
  • •the exercise program started after healing of the burn (after burn injury by 6 weeks)

排除标准

  • •conditions that may affect on participation in the exercise program as a recent coronary disease, uncontrolled hypertension, orthopedic problems limiting exercise, abnormal cardiac stress test, pregnant women, refusal to participate in a physical activity program,
  • •presence of psychological or cognitive disorders (aggressive behavior, impulsivity, dementia)
  • •food intolerance to milk protein products.

研究组 & 干预措施

Protein+ Exercise group

Experimental

Received oral protein supplementation, exercise program and traditional burn care

干预措施: whey protein supplementation powder (Inkospor X-TREME; France) (Dietary Supplement)

Protein+ Exercise group

Experimental

Received oral protein supplementation, exercise program and traditional burn care

干预措施: Exercise training program (Other)

Protein+ Exercise group

Experimental

Received oral protein supplementation, exercise program and traditional burn care

干预措施: traditional burn care (Other)

Protein group

Experimental

Received oral protein supplementation and traditional burn care

干预措施: whey protein supplementation powder (Inkospor X-TREME; France) (Dietary Supplement)

Protein group

Experimental

Received oral protein supplementation and traditional burn care

干预措施: traditional burn care (Other)

Exercise group

Experimental

Received exercise program and traditional burn care

干预措施: Exercise training program (Other)

Exercise group

Experimental

Received exercise program and traditional burn care

干预措施: traditional burn care (Other)

Control group

Other

Received traditional burn care

干预措施: traditional burn care (Other)

结局指标

主要结局

lean body mass

时间窗: after 12 week of intervention

The QDR 4500A densitometry system DXA (Hologic Inc., Bedford, USA) was used according to the manufacturer instructions for calculating LBM

次要结局

  • muscle strength(after 12 week of intervention)

研究者

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

Nesma Morgan Allam

Lecturer

Cairo University

研究点 (1)

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