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临床试验/NCT06612372
NCT06612372招募中不适用

Effects of 60-day-6° Head-down Bed Rest on Cartilage and Function of the Knee Joint

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2023年9月10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
26
试验地点
1
主要终点
T2 mapping

研究概览

简要总结

Objective: To investigate the effects of long-term simulated unloading in bed on articular cartilage quality based on functional magnetic resonance imaging (FMRI) and Knee joint function.

详细描述

A total of 26 subjects were recruited for a 60-day period of head-down bed rest (HDBR). The bed rest position is a 6° downward tilt of the head, and all daily activities are performed in this position. We will perform functional MRI scans of the right knee joint using T2 mapping sequences to assess tissue composition and water content before and after HDBR. Functional assessments, including the Y-Balance Test and International Knee Documentation Committee (IKDC) scores, were performed pre-HDBR and post-HDBR.We will divide each participant's knee cartilage into 18 regions and measured T2 values according to the whole organ magnetic resonance imaging score (WORMS) partitioning method.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •(1) male; (2) age 25-50 years old; (3) height between 160-175 cm, weight ≥50kg, and BMI between 18.5-26 kg/m²; (4) good general health status.

排除标准

  • •(1) history of alcoholism; (2) smoking ≥5 cigarettes/day in the 3 months before the test; (3) drug dependence or use of medications affecting bone metabolism within 2 weeks before screening; (4) presence of metal implants, severe vertigo, or severe snoring.

研究组 & 干预措施

Long term bed rest intervention group

Experimental

60-day-6° head-down bed rest

干预措施: 60-day-6° head-down bed rest (Behavioral)

结局指标

主要结局

T2 mapping

时间窗: three days before the HDBR started and three days after the HDBR ended

metabolic and microstructural changes within the articular cartilage matrix components can be assessed, reflecting collagen fiber structure integrity and water content within the tissue

次要结局

  • Y-balance test(three days before the HDBR started and three days after the HDBR ended)
  • International Knee Documentation Committee (IKDC) scores(three days before the HDBR started and three days after the HDBR ended)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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