Qigong Intervention Program for Abused Chinese Women

May 28, 2016 updated by: Professor Agnes Tiwari, The University of Hong Kong

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

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.

Study Overview

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

Interventional

Enrollment (Actual)

271

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong, China
        • HKSKH Lady MacLehose Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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).

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
pre-intervention (baseline) and post-intervention (5.5 months later)
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.
pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)
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.
pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)
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.
pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)
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.
pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

February 6, 2014

First Submitted That Met QC Criteria

February 9, 2014

First Posted (Estimate)

February 11, 2014

Study Record Updates

Last Update Posted (Estimate)

June 1, 2016

Last Update Submitted That Met QC Criteria

May 28, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • UW 12-555

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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