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Qigong Intervention Program for Abused Chinese Women

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ClinicalTrials.gov Identifier: NCT02060123
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
Professor Agnes Tiwari, The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Abused Women Behavioral: Qigong training Other: Wait-list control- Health talks Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 271 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized, Wait-list Controlled Trial of a Qigong Intervention Program on Telomerase Activity and Psychological Stress in Abused Chinese Women
Study Start Date : March 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: 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).
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).

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.
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.




Primary Outcome Measures :
  1. Change in telomerase activity [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in level of pro-inflammatory cytokines [ Time Frame: pre-intervention (baseline) and post-intervention (5.5 months later) ]
    The peripheral blood plasma will also be analyzed for pro-inflammation cytokines TNF-alpha and IL-6 levels.

  2. Change in perceived stress [ Time Frame: pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later) ]
    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.

  3. Change in perceived coping [ Time Frame: pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later) ]
    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.

  4. Change in depressive symptoms [ Time Frame: pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later) ]
    The Chinese version of the Beck Depression Inventory version II (BDI-II) will be used to assess depressive symptoms in the previous two weeks.

  5. Change in sleep disturbance [ Time Frame: pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later) ]
    The Chinese version of the General Sleep Disturbance Scale (GSDS), a 21-item questionnaire, will be used to measure participants' sleep disturbance.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060123


Locations
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China
HKSKH Lady MacLehose Center
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Agnes Tiwari, PhD The University of Hong Kong

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Agnes Tiwari, Professor and Head, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02060123     History of Changes
Other Study ID Numbers: UW 12-555
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016

Keywords provided by Professor Agnes Tiwari, The University of Hong Kong:
Qigong
Telomerase
Perceived stress
RCT
Chinese
Abused women
intervention
Depression