Qigong Intervention Program for Abused Chinese Women

Abused Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060123
• Other study ID #: UW 12-555
• Status: Completed
• Phase: N/A
• First received: February 6, 2014
• Last updated: May 28, 2016
• Start date: March 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Abused Women

Intervention

Behavioral:
• Qigong training
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).

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.

Locations

Country	Name	City	State
China	HKSKH Lady MacLehose Center	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. Review. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No