NCT02060123

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
271

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

2.2 years

First QC Date

February 6, 2014

Last Update Submit

May 28, 2016

Conditions

Keywords

QigongTelomerasePerceived stressRCTChineseAbused womeninterventionDepression

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (5)

  • Change in level of pro-inflammatory cytokines

    pre-intervention (baseline) and post-intervention (5.5 months later)

  • Change in perceived stress

    pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)

  • Change in perceived coping

    pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)

  • Change in depressive symptoms

    pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)

  • Change in sleep disturbance

    pre-intervention (baseline), post-training (6 weeks later) and post-intervention (5.5 months later)

Study Arms (2)

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).

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.

Other: Wait-list control- Health talks

Interventions

Qigong trainingBEHAVIORAL

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).

Qigong 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.

Wait-list control- Health talks

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HKSKH Lady MacLehose Center

Hong Kong, China

Location

Related Publications (7)

  • 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.

    PMID: 22736201BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 20594090BACKGROUND
  • Cheung 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.

  • Hameed 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.

  • Cheung 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.

  • Tiwari 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.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Agnes Tiwari, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head

Study Record Dates

First Submitted

February 6, 2014

First Posted

February 11, 2014

Study Start

March 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations