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临床试验/NCT06141291
NCT06141291已完成不适用

Neuromuscular Decline After Physical Inactivity: a Comparison of Younger and Older Adults

Science and Research Centre Koper2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2023年8月21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
29
试验地点
2
主要终点
Insulin sensitivity

研究概览

简要总结

The study will consist of three groups of subjects. Ten young male subjects (18-30 years) will lie supine for 21 days, 10 older male subjects (65+ years) will lie supine for 10 days, and a third group of 10 older male subjects (65+ years) will also lie supine for 10 days but will receive interventions (see below) to counteract the physical changes caused by supine lying. All three groups will be bedridden in the premises of Izola General Hospital. Subjects will be housed in 5-bed rooms at the hospital and will receive 24-hour medical care, proper hygiene, nutrition, passive exercise, Internet, a relaxing environment, and visits. After their stay, subjects return home but receive 21 days of care at local fitness centers. Rehabilitation consists of interval training, in which subjects perform high-intensity exercise for 4 times 5 minutes. A number of important health parameters are measured before, during, and after bed rest. Some of these measurements will be invasive (blood and muscle sampling), for which appropriate medical personnel, sterile instruments, and environment will be available. Measurements will include normal voluntary efforts (indoor cycling, various jumps, short stretches) and electrically evoked muscle contractions (electrical stimulation with single impulses). All tests are normal tests and come from normal lifestyles and routine medical examinations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • age: for young arm (18-35), for old arm (65-75)
  • BMI: 22 in 32 kg/m2
  • appendicular muscle mass > 7,23 kg/m2

排除标准

  • serious acute or chronic diseases: skeletal, cancer, cardiovascular, metabolic, neuromuscular and psychiatric;
  • cardiovascular disease detected on ECG examination;
  • allergies to the active substances used in the study;
  • problems with digestion of the active substances;
  • frequent diarrhea and vomiting;
  • arterial hypertension (>140/90 mmHg);
  • psychological problems;
  • susceptibility to deep vein thrombosis (D-dimer < 500 μg/L)
  • poor orthostatic tolerance (frequent dizziness when changing position, especially when rising from a supine position);
  • venous abnormalities that would cause difficulty in drawing blood;
  • a large blood volume (more than 300 ml) in the last 3 months prior to the start of the project;
  • problems with excessive consumption of alcoholic beverages;
  • active smoking;
  • Previous participation in any biomedical research in the last 3 months prior to the start of this study;
  • a communicable disease before the start of the project;
  • any ferromagnetic implant.

结局指标

主要结局

Insulin sensitivity

时间窗: 10 days

Assessment in changes in insulin sensitivity will be made with the use of Oral Glucose Tolerance test (OGTT).

次要结局

  • Muscle force(10 days)
  • Muscle mass(10 day)
  • Neuromuscular junction stability(10 days)

研究者

发起方
Science and Research Centre Koper
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rado Pisot

Director, Scientific councillor

Science and Research Centre Koper

研究点 (2)

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