跳至主要内容
临床试验/NCT03405727
NCT03405727撤回不适用

Improvement of Sarcopenia in Sarcopenia Patients Following Two Different Diets

Brugmann University Hospital1 个研究点 分布在 1 个国家开始时间: 2018年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
"Time Up and Go" test

研究概览

简要总结

Sarcopenia is defined as a decrease in muscular strength and muscle mass, accompanied by a decrease in physical performance. Seniors might develop sarcopenia because of a decreased physical activity and a decreased protein intake. Many patients also develop sarcopenia after a long stay in an intensive care unit.

Protein intake is very important when treating sarcopenia. However, meeting the protein requirements at home proves difficult. Oral dietary supplements, given in addition to the other known recommendations, might provide a solution.

This study will assess the efficacy of the oral dietary supplements for the treatment of sarcopenia.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients hospitalized within the CHU Brugmann, Brussels
  • •Patients diagnosed with sarcopenia (by means of a dynamometer)
  • •Patients having stayed in an intensive care unit for longer than 5 weeks

排除标准

  • •Oncology patients
  • •Anorexic patients
  • •Patients having a life expectancy of less than 6 months
  • •Demented patients
  • •BPCO patients
  • •Patients with neuropathies

研究组 & 干预措施

Standard treatment

No Intervention

Oral dietary supplements

Experimental

干预措施: Oral dietary supplements (Dietary Supplement)

结局指标

主要结局

"Time Up and Go" test

时间窗: 6 months after first consultation

Mobility assessment of the patient

Prehension force

时间窗: 6 months after first consultation

Prehension force, as measured by a dynamometer on the dominant hand

Sedentary lifestyle questionnaire

时间窗: 6 months after first consultation

Evaluation of the physical activity by means of a questionnaire

Fat mass evaluation

时间窗: 6 months after first consultation

Measured by a Harpaden compass on the tricipital skin fold

Muscle mass evaluation

时间窗: 6 months after first consultation

Brachial muscular circumference (measured by tape)

Walking speed

时间窗: 6 months after first consultation

Walking speed on a 4 meters distance

Prehension force

时间窗: 3 months after first consultation

Prehension force, as measured by a dynamometer on the dominant hand

Fat mass evaluation

时间窗: 3 months after first consultation

Measured by a Harpaden compass on the tricipital skin fold

Muscle mass evaluation

时间窗: 3 months after first consultation

Brachial muscular circumference (measured by tape)

Walking speed

时间窗: 3 months after first consultation

Walking speed on a 4 meters distance

"Time Up and Go" test

时间窗: 3 months after first consultation

Mobility assessment of the patient

Sedentary lifestyle questionnaire

时间窗: 3 months after first consultation

Evaluation of the physical activity by means of a questionnaire

次要结局

未报告次要终点

研究者

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

Tatiana Besse-Hammer

Head of clinic

Brugmann University Hospital

研究点 (1)

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