Clinical trial NCT02060123: Qigong Intervention Program for Abused Chinese Women
Official title: A Randomized, Wait-list Controlled Trial of a Qigong Intervention Program on Telomerase Activity and Psychological Stress in Abused Chinese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abused Women
Keywords: Qigong
Telomerase
Perceived stress
RCT
Chinese
Abused women
intervention
Depression
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 271
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in telomerase activity
timeFrame: pre-intervention (baseline) and post-intervention (5.5 months later)
Secondary outcomes:
measure: Change in level of pro-inflammatory cytokines
timeFrame: pre-intervention (baseline) and post-intervention (5.5 months later)
measure: Change in perceived stress
timeFrame: pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)
measure: Change in perceived coping
timeFrame: pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)
measure: Change in depressive symptoms
timeFrame: pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)
measure: Change in sleep disturbance
timeFrame: pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: HKSKH Lady MacLehose Center
Study officials:
affiliation: The University of Hong Kong
name: Agnes Tiwari, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ho RT, Chan JS, Wang CW, Lau BW, So KF, Yuen LP, Sham JS, Chan CL. A randomized controlled trial of qigong exercise on fatigue symptoms, functioning, and telomerase activity in persons with chronic fatigue or chronic fatigue syndrome. Ann Behav Med. 2012 Oct;44(2):160-70. doi: 10.1007/s12160-012-9381-6.
citation: Zhang GD. The impacts of 48-form tai chi chuan and yi qi yang fei gong on the serum levels of IgG, IgM, IgA, and IgE in human. Journal of Beijing Institute of Physical Education. 1990;4:12-4.
citation: Jahnke R, Larkey L, Rogers C, Etnier J, Lin F. A comprehensive review of health benefits of qigong and tai chi. Am J Health Promot. 2010 Jul-Aug;24(6):e1-e25. doi: 10.4278/ajhp.081013-LIT-248.
citation: Cheung DST, Chau PH, Yeung WF, Deng W, Hong AWL, Tiwari AFY. Assessing the effect of a mind-body exercise, qigong Baduanjin, on sleep disturbance among women experiencing intimate partner violence and possible mediating factors: a randomized-controlled trial. J Clin Sleep Med. 2021 May 1;17(5):993-1003. doi: 10.5664/jcsm.9102.
citation: Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2.
citation: Cheung DST, Deng W, Tsao SW, Ho RTH, Chan CLW, Fong DYT, Chau PH, Hong AWL, Fung HYKY, Ma JLC, Tiwari AFY. Effect of a Qigong Intervention on Telomerase Activity and Mental Health in Chinese Women Survivors of Intimate Partner Violence: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e186967. doi: 10.1001/jamanetworkopen.2018.6967.
citation: Tiwari A, Chan CL, Ho RT, Tsao GS, Deng W, Hong AW, Fong DY, Fung HY, Pang EP, Cheung DS, Ma JL. Effect of a qigong intervention program on telomerase activity and psychological stress in abused Chinese women: a randomized, wait-list controlled trial. BMC Complement Altern Med. 2014 Aug 15;14:300. doi: 10.1186/1472-6882-14-300.