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临床试验/NCT02060123
NCT02060123已完成不适用

A Randomized, Wait-list Controlled Trial of a Qigong Intervention Program on Telomerase Activity and Psychological Stress in Abused Chinese Women

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 271 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
271
试验地点
1
主要终点
Change in telomerase activity

研究概览

简要总结

The purpose of this study is to evaluate the effect of a qigong intervention program on telomerase activity in Chinese women with a history of intimate partner violence.

详细描述

Qigong is a mind-body exercise rooted in the paradigm of traditional Chinese medicine, aiming to achieve a harmonious flow of energy (qi) in the body through gentle movements and is thus considered as a holistic health practice towards promoting physical and mental well-being and improving longevity. It was suggested that qigong exercise, as a stress management strategy, could be effective in improving psychological symptoms, as well as enhancing cellular telomerase activity by reducing oxidative stress level and regulating immune response.

The study is to evaluate the effects of a qigong intervention on telomerase activity and pro-inflammation cytokines, perceived stress, perceived coping, and depressive symptoms in Chinese women with a history of intimate partner violence. The study design is a randomized, wait-list controlled design with intervention and wait-list control groups. A total of 240 Chinese abused women will be recruited. The qigong intervention program consists of: (i) a 2-hr group qigong training twice a week for 6 weeks; (ii) weekly group follow-up of a 1-hour group qigong exercise for 4 months; and (iii) self-practice of qigong exercise for 30 minutes each day throughout the intervention period lasting 5.5 months. It is hypothesized that the participants in the intervention group will have higher levels of telomerase activity and perceived coping, and lower levels of pro-inflammation cytokines, perceived stress, and depressive symptoms, on completion of a qigong intervention program, compared to abused Chinese women in the wait-list control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • 18 years of age or older,
  • willing to undertake the qigong intervention program,
  • available for all testing points,
  • receptive to random allocation, and
  • assessed to be abused by an intimate partner in the preceding year or longer, based on the Chinese Abuse Assessment Screen.

排除标准

  • had participated in qigong training or other mind body intervention within the previous 6 months, or
  • have serious medical conditions that might limit their participation in qigong exercise (based on our previous experience, such conditions include cancer, severe obesity, narcolepsy, major depressive disorder, schizophrenia), or
  • have psychiatric disorders, or
  • use medication or other psychological intervention for stress, or
  • are abused by someone who is not their intimate partner.

结局指标

主要结局

Change in telomerase activity

时间窗: pre-intervention (baseline) and post-intervention (5.5 months later)

For each participant, 10 ml of peripheral blood will be collected for measurements of telomerase activity at two time points: pre-intervention (T0) and post-intervention (T2) in the intervention group, as well as in wait-list control group before qigong training.

次要结局

  • Change in level of pro-inflammatory cytokines(pre-intervention (baseline) and post-intervention (5.5 months later))
  • Change in sleep disturbance(pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later))
  • Change in perceived stress(pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later))
  • Change in perceived coping(pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later))
  • Change in depressive symptoms(pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later))

研究者

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

Professor Agnes Tiwari

Professor and Head

The University of Hong Kong

研究点 (1)

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