Abused WomenNCT02060123
Qigong Intervention Program for Abused Chinese Women
A study testing Qigong training in people with Abused Women, run by The University of Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abused Women
- What is being tested?
- Qigong training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Abused Women
- Being tested
- Qigong training, Wait-list control- Health talks
- Keywords
- Qigong, Telomerase, Perceived stress, RCT, Chinese, Abused women, intervention, Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qigong trainingBehavioural
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 talksOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Qigong training | Experimental | 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). Receives: Behavioral: Qigong training |
| 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. Receives: Other: Wait-list control- Health talks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-intervention (baseline) and post-intervention (5.5 months later)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Abused WomenStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Agnes Tiwari, The University of Hong Kong
- Investigators
- Agnes Tiwari, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060123
- Sponsor's protocol ID
- UW 12-555
- Status last verified
- May 2016
- First submitted
- 6 Feb 2014
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22736201Zhang 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.
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.
PubMed 20594090Cheung DST, Chau PH, Yeung WF, Deng W, Hong AWL, Tiwari AFY. Assessing the effect of a mind-body exercise, qigong Baduanjin, on sleep disturbance among women experiencing intimate partner violence and possible mediating factors: a randomized-controlled trial. J Clin Sleep Med. 2021 May 1;17(5):993-1003. doi: 10.5664/jcsm.9102.
PubMed 33551021Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2.
PubMed 32608505Cheung DST, Deng W, Tsao SW, Ho RTH, Chan CLW, Fong DYT, Chau PH, Hong AWL, Fung HYKY, Ma JLC, Tiwari AFY. Effect of a Qigong Intervention on Telomerase Activity and Mental Health in Chinese Women Survivors of Intimate Partner Violence: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e186967. doi: 10.1001/jamanetworkopen.2018.6967.
PubMed 30646209Tiwari A, Chan CL, Ho RT, Tsao GS, Deng W, Hong AW, Fong DY, Fung HY, Pang EP, Cheung DS, Ma JL. Effect of a qigong intervention program on telomerase activity and psychological stress in abused Chinese women: a randomized, wait-list controlled trial. BMC Complement Altern Med. 2014 Aug 15;14:300. doi: 10.1186/1472-6882-14-300.
PubMed 25127878
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Wait-list Controlled Trial of a Qigong Intervention Program on Telomerase Activity and Psychological Stress in Abused Chinese Women
- ClinicalTrials.gov ID
- NCT02060123
- Acronym / sponsor ID
- UW 12-555
- Conditions
- Abused Women
- Keywords
- Qigong, Telomerase, Perceived stress, RCT, Chinese, Abused women, intervention, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qigong training | Experimental | Behavioral: Qigong traininga 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 | Other: Wait-list control- Health talksMonthly 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qigong traininga 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). | Behavioural | Qigong training |
| Wait-list control- Health talksMonthly 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 |
Primary outcome
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.
5 secondary outcomes
Change in level of pro-inflammatory cytokines
Time frame: 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)
Change in perceived coping
Time frame: 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)
Change in sleep disturbance
Time frame: pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Background: PubMed 22736201Ho 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.
- BackgroundZhang 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.
- Background: PubMed 20594090Jahnke 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.
- Derived from this study: PubMed 33551021Cheung DST, Chau PH, Yeung WF, Deng W, Hong AWL, Tiwari AFY. Assessing the effect of a mind-body exercise, qigong Baduanjin, on sleep disturbance among women experiencing intimate partner violence and possible mediating factors: a randomized-controlled trial. J Clin Sleep Med. 2021 May 1;17(5):993-1003. doi: 10.5664/jcsm.9102.
- Derived from this study: PubMed 32608505Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2.
- Derived from this study: PubMed 30646209Cheung DST, Deng W, Tsao SW, Ho RTH, Chan CLW, Fong DYT, Chau PH, Hong AWL, Fung HYKY, Ma JLC, Tiwari AFY. Effect of a Qigong Intervention on Telomerase Activity and Mental Health in Chinese Women Survivors of Intimate Partner Violence: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e186967. doi: 10.1001/jamanetworkopen.2018.6967.
- Derived from this study: PubMed 25127878Tiwari A, Chan CL, Ho RT, Tsao GS, Deng W, Hong AW, Fong DY, Fung HY, Pang EP, Cheung DS, Ma JL. Effect of a qigong intervention program on telomerase activity and psychological stress in abused Chinese women: a randomized, wait-list controlled trial. BMC Complement Altern Med. 2014 Aug 15;14:300. doi: 10.1186/1472-6882-14-300.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnes Tiwari, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qigong training in people with Abused Women, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in telomerase activity (time frame: pre-intervention (baseline) and post-intervention (5.5 months later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02060123, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.