- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02060123
Qigong Intervention Program for Abused Chinese Women
A Randomized, Wait-list Controlled Trial of a Qigong Intervention Program on Telomerase Activity and Psychological Stress in Abused Chinese Women
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong, China
- HKSKH Lady MacLehose Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Qigong training
a total of 103 hours over a period of 5.5 months, consisting of:
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a total of 103 hours over a period of 5.5 months, consisting of:
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Other: Wait-list control- Health talks
Monthly health education talks unrelated to qigong will be provided starting from the point when the intervention group starts the qigong weekly follow-up.Once the intervention group has completed the qigong intervention program, the wait-list control group will receive the qigong exercise training.
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Monthly health education talks unrelated to qigong will be provided starting from the point when the intervention group starts the qigong weekly follow-up.Once the intervention group has completed the qigong intervention program, the wait-list control group will receive the qigong exercise training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in telomerase activity
Time Frame: pre-intervention (baseline) and post-intervention (5.5 months later)
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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.
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pre-intervention (baseline) and post-intervention (5.5 months later)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in level of pro-inflammatory cytokines
Time Frame: pre-intervention (baseline) and post-intervention (5.5 months later)
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The peripheral blood plasma will also be analyzed for pro-inflammation cytokines TNF-alpha and IL-6 levels.
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pre-intervention (baseline) and post-intervention (5.5 months later)
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Change in perceived stress
Time Frame: pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)
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The 10-item Perceived Stress Scale (PSS), the most widely used psychological instrument for measuring the perception of stress, will be used to assess the degree to which situations in life are perceived by the participant as stressful during the past month.
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pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)
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Change in perceived coping
Time Frame: pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)
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The Perceived Coping Scale (PCS) will be used to assess the types and perceived effectiveness of each of the 13 specific strategies used by the participant in dealing with violence perpetrated by her intimate partner.
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pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)
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Change in depressive symptoms
Time Frame: pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)
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The Chinese version of the Beck Depression Inventory version II (BDI-II) will be used to assess depressive symptoms in the previous two weeks.
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pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)
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Change in sleep disturbance
Time Frame: pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)
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The Chinese version of the General Sleep Disturbance Scale (GSDS), a 21-item questionnaire, will be used to measure participants' sleep disturbance.
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pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UW 12-555
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