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Completed

NCT Number: NCT02060123

Qigong Intervention Program for 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.

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Key information

Conditions

Abused Women Behavior Behavioral Symptoms Depression

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

HKSKH Lady MacLehose Center

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Qigong Training

Behavioral

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

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 11, 2014
Registry last updated
Jun 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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