跳至主要内容
临床试验/CTRI/2021/02/030980
CTRI/2021/02/030980招募中不适用

Molecular, Cell survival and Neuro-cognitive effects of Yoga intervention in stress induced Cognitive Impairment in Prisoners and its efficacy in animal model of memory loss

Post Graduate Institute of Medical Education Research4 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年5月2日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
4
主要终点
BDNF, VEGF, IL-6,TNF-α, CRP, Cortisol, Dnmt-1,CD34, CD45, CD117, FBS, Mini-Mental State Examination Test (MMSE), Perceived Stress Scale (PSS), State trait anxiety inventory (STAI), WHOQOL-BREF, Hamilton Depression Rating Scale (HAM-D/HDRS), Trail making test (A and B), Stroop color and word test, Wechsler Memory Scale, PPBS, FBS.

研究概览

简要总结

Cognition is one of the most important process of human brain physiology. There are many factors that govern cognition which makes it vulnerable to imperfections. Any insult like brain damage, stress, depression, anxiety, fear, physical and chemical factors affect hippocampal health and result in diminished memory and cognition. Jail inmates may be the best population to study the association of these risk factors with cognition compared to other. It has been seen that prisoners are under constant stress, depression, anxiety and tension during the life of imprisonment. These factors are the major cause of mental health problems if remains untreated over long period of time. Little is still known about the consequences of prisoner life and their general health conditions in India. Over a long period of isolation in prisons, their mental health status may change leading to feeling of frustration, stress, anger and anxiety. Some coping strategies that address the physical, emotional, cognitive, social, and spiritual domains are promising intervention techniques that can help in improving well-being among the prisoner population. Currently the first line treatments for cognitive disorder includes pharmaceutical agents and psychological interventions, haven’t shown much relief and hope with repeated failure of clinical trials. Lifestyle modifications may have an impact on preventing the progression of such cognitive loss subsequently leading to AD. In this proposal, we propose to administer a customized Yoga protocol to alleviate stress induced cognitive impairment amongst the prisoners and its possible role in either reducing a significant risk factor for cognitive decline and dementia or improving the quality of life. Therefore, it would be scientifically compelling to examine the behavioral parameters to analyze the impact of threatful and fearsome condition on social and associated epigenetic and molecular alteration as well as yoga intervention. Our study plan is based on the focus that prisoners are continuously associated with stress, anxiety and depression which is a known cause of cognitive impairment and whether it is alleviated by a customized Yoga protocol. Furthermore, the efficacy of this protocol will be established by using the lineage negative cells by yoga practicing individuals into animal model of memory loss.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • No previous experience in Yoga.
  • Giving consent to participate.

排除标准

  • Those not giving consent to participate.
  • Noncooperative and aggressive behavior.
  • Severe cognitive impairment.
  • Previous experience in Yoga.

结局指标

主要结局

BDNF, VEGF, IL-6,TNF-α, CRP, Cortisol, Dnmt-1,CD34, CD45, CD117, FBS, Mini-Mental State Examination Test (MMSE), Perceived Stress Scale (PSS), State trait anxiety inventory (STAI), WHOQOL-BREF, Hamilton Depression Rating Scale (HAM-D/HDRS), Trail making test (A and B), Stroop color and word test, Wechsler Memory Scale, PPBS, FBS.

时间窗: At baseline and after two months

次要结局

  • Animal study:(Morris Water Maze, Passive avoidance, Histology and IHC: caspase3, Aβ)

研究者

申办方类型
Research institution and hospital

研究点 (4)

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