Qigong Intervention Program for Abused Chinese Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Abused Women

Intervention / Treatment
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* Behavioral: Qigong training
* Other: Wait-list control- Health talks


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qigong training<br>a total of 103 hours over a period of 5.5 months, consisting of: Group learning and practice: a 2-hour qigong exercise training session will be provided by a qigong master twice a week for six consecutive weeks (24 hours), Weekly group follow-up: a 1-hour qigong exercise will be conducted with reinforcement of learning and remedial teaching by a qigong master once a week for four consecutive months (16 hours) after the group learning and practice, and Self-practice: participant will engage in qigong exercise for 30 minutes every day for the whole intervention period lasting 5.5 months (63 hours). | Behavioral: Qigong training<br>* a total of 103 hours over a period of 5.5 months, consisting of: Group learning and practice: a 2-hour qigong exercise training session will be provided by a qigong master twice a week for six consecutive weeks (24 hours), Weekly group follow-up: a 1-hour qigong exercise will be conducted with reinforcement of learning and remedial teaching by a qigong master once a week for four consecutive months (16 hours) after the group learning and practice, and Self-practice: participant will engage in qigong exercise for 30 minutes every day for the whole intervention period lasting 5.5 months (63 hours).<br>|
| Other: Wait-list control- Health talks<br>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. | Other: Wait-list control- Health talks<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in telomerase activity | 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. | pre-intervention (baseline) and post-intervention (5.5 months later) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of pro-inflammatory cytokines | The peripheral blood plasma will also be analyzed for pro-inflammation cytokines TNF-alpha and IL-6 levels. | pre-intervention (baseline) and post-intervention (5.5 months later) | 
| Change in perceived stress | 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. | pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later) | 
| Change in perceived coping | 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. | pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later) | 
| Change in depressive symptoms | The Chinese version of the Beck Depression Inventory version II (BDI-II) will be used to assess depressive symptoms in the previous two weeks. | pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later) | 
| Change in sleep disturbance | The Chinese version of the General Sleep Disturbance Scale (GSDS), a 21-item questionnaire, will be used to measure participants' sleep disturbance. | pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Qigong, Telomerase, Perceived stress, RCT, Chinese, Abused women, intervention, Depression