MARS-PRE: MARcatori Biologici e Funzionali Per la Biomedicina aStronautica di PREcisione
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Neurological outcomes - nerve conduction velocity
研究概览
简要总结
In the current study the investigators will study early biomarkers of human degradation. In 10-day horizontal bed rest the investigators will enroll 10 healthy male subjects (18-30years, BMI 20-28kg/m2). Pre-, mid- and post-bed rest the investigators will perform various measurements, some of them will be invasive (blood samples and muscle biopsies), which will be carefully taken by the medical staff. The subjects will be placed in hospital rooms and have 24-hour medical supervision, adequate hygiene, nutrition, passive exercise, entertainment and visits.
详细描述
Ten young male participants will undergo 10 days of horizontal bed rest. Before, during and after the investigators will monitor many biomechanical, metabolic, cardiovascular, biochemical responses.
During the bed rest period there will be no interventions. subjects will be allowed to rotate freely, with no vertical stimulus of any-kind.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 20 - 28 kg/m2
- •male participants
- •a healthy individual who is able to complete all the tests planned in the research protocol
排除标准
- •regular alcohol consumption;
- •ferromagnetic implants;
- •history of deep vein thrombosis with D-dimer > 500 μg·L-1;
- •acute or chronic skeletal, neuromuscular, psychological, metabolic and cardiovascular disease conditions.
结局指标
主要结局
Change in Neurological outcomes - nerve conduction velocity
时间窗: At baseline and after 10-day bed rest
Change in nerve conduction velocity after 10-day bed rest
Change in skeletal muscle single fibre force (in micro Newtons)
时间窗: At baseline and after 10-day bed rest
In each aprticipants at each time point approx 10 intact muscle fibres will be studied for their force production after 10-day bed rest. Isometric muscle fibre force (in mNewton) will be measured isometric force (Fo) in four subsequent maximal activations (pCa, 4.6; sarcomere length, 2.6 micrometers; temperature 12 degrees C) using an electrical motor with force transducer mounted on it.
Change in Neurological outcomes - fMRI
时间窗: At baseline and after 10-day bed rest
Change in ability to mentally imagine/perform locomotory tasks (voxel-based network analyses) after 10-day bed rest
Change in mittochondria respiration rate
时间窗: At baseline and after 10-day bed rest
Change in Mittochondria oxygen respiration rate per mg of muscle tissue after 10-day bed rest
Change in skeletal muscle NCAM expression in single fibres
时间窗: Before, at day 5 and day 10 of bed rest
Neural cell adhesion molecule (NCAM) expression will be analysed in vastus lateralis biopsy samples at three time points.
Change in Neurological outcomes - neurocognitive assessment
时间窗: At baseline and after 10-day bed rest
Change in EEG and neurocognitive tasks parameters (event related potential; P300 component during Stroop task) after 10-day bed rest
次要结局
- Change in balance after 10-day bed rest(At baseline and after 10-day bed rest)
- Change in peak aerobic power after 10-day bed rest(At baseline and after 10-day bed rest)
- Change in orthostatic tolerance after 10-day bed rest(At baseline and after 10-day bed rest)
- Change in muscle volume after 10-day bed rest(At baseline and after 10-day bed rest)
- Change in maximal displacement after twitch contraction after 10-day bed rest(At baseline, every 2 days of bed rest and after 10-day bed rest)
- Nonhomogeneous change in skeletal muscle pennation angle after 10-day bed rest(At baseline, every 2 days of bed rest and after 10-day bed rest)
- Change in skeletal composition after 10-day bed rest(At baseline, day 5 and after 10-day bed rest)
- Change in skeletal muscle maximal voluntary contraction after 10-day bed rest(At baseline and after 10-day bed rest)
研究者
Rado Pisot
prof. Rado Pisot, PhD, prof. Marco Narici, MD, PhD, prof. Bostjan Simunic, PhD, Assistant professor Uros Marusic, PhD,
Science and Research Centre Koper