Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000833369
Ethics application status
Approved
Date submitted
24/04/2017
Date registered
6/06/2017
Date last updated
6/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of qigong on meridian system, heart rate variability and quality of life
Scientific title
Effect of qigong on meridian system, heart rate variability and quality of life in healthy adult volunteers
Secondary ID [1] 291763 0
RD104040
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
meridian state 302990 0
heart rate variability 303433 0
quality of life 303434 0
Condition category
Condition code
Alternative and Complementary Medicine 302456 302456 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Practice qigong. Chinese Bioenergy Qigong is a 1-hour session of qigong exercise, which includes warm up movements, breathing regulation, gentle movements, body stretching, meditation, and relaxation. Additional details can be obtained from the following webpages:
http://www.ck17.org/ck17/index.php?option=com_content&view=category&id=40&Itemid=84
https://www.youtube.com/watch?v=M8b6WkAlLB8
Deliver: Dr. Tze-Taur Wei
Dr. Tze-Taur Wei is a medical doctor expertizing in both qigong and naturopathic medicine. He is also received complete research training during his DrPH program.
Mode of delivery: face to face and provided in a group
Times the intervention: 1
Duration: 60 minutes
Location: park
Intervention code [1] 297878 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301867 0
Change in meridian analysis using the Meridian Electroacupuncture Analysis Device, MEAD the 6th generation, Medpex Enterprises, Taiwan
Timepoint [1] 301867 0
Baseline, and at 30 minutes after intervention commencement (qigong exercise)
Secondary outcome [1] 334165 0
heart rate

Polar heart-rate monitors (Polar Vantage NV, Polar Electro Oy, Finland) were used to continuously collect heart rate data in the form of RR intervals from all participants before and after one session of qigong exercise.
Timepoint [1] 334165 0
Baseline, and at 30 minutes after intervention commencement (qigong exercise)
Secondary outcome [2] 334166 0
heart rate variability

After data collection, HRV parameters were calculated using Kubios HRV (version 2.1; Biosignal Analysis and Medical Imaging Group, University of Eastern Finland, Finland). The participants’ spectral HRV data were expressed in terms of RR intervals, lower frequency (LF), high frequency (HF), normalized LF, and normalized HF.
Timepoint [2] 334166 0
Baseline, and at 30 minutes after intervention commencement (qigong exercise)
Secondary outcome [3] 334167 0
Short Form 36 Health Survey
Timepoint [3] 334167 0
Baseline, and at 30 minutes after intervention commencement (qigong exercise)
Secondary outcome [4] 335258 0
State Trait Anxiety Inventory
Timepoint [4] 335258 0
Baseline, and at 30 minutes after intervention commencement (qigong exercise)

Eligibility
Key inclusion criteria
healthy volunteers including male and female who practice qigong regularly will be recruited.
Practicing Chinese Bioenergy Qigong 5 days a week for at least 3 months were eligible to be recruited in this study.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) currently suffering from a major illness (ex: AMI, stroke, late stage cancer, paralysis, major organ transplantation);
(2) currently pregnant

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/09/2015
Date of last participant enrolment
Anticipated
Actual
5/11/2015
Date of last data collection
Anticipated
Actual
5/11/2015
Sample size
Target
50
Accrual to date
Final
45
Recruitment outside Australia
Country [1] 8843 0
Taiwan, Province Of China
State/province [1] 8843 0

Funding & Sponsors
Funding source category [1] 296265 0
Hospital
Name [1] 296265 0
Show Chwan Memorial Hospital
Country [1] 296265 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Show Chwan Memorial Hospital
Address
542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 295181 0
None
Name [1] 295181 0
Address [1] 295181 0
Country [1] 295181 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297500 0
Institutional Review Board of Show Chwan Memorial Hospital
Ethics committee address [1] 297500 0
Ethics committee country [1] 297500 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 297500 0
Approval date [1] 297500 0
31/05/2015
Ethics approval number [1] 297500 0
1040408

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1660 1660 0 0
/AnzctrAttachments/372795-Ethics Committee approval letter.pdf (Ethics approval)

Contacts
Principal investigator
Name 74238 0
Dr Chun-Yi Lin
Address 74238 0
Department of Nuclear Medicine, Show Chwan Memorial Hospital
542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Country 74238 0
Taiwan, Province Of China
Phone 74238 0
+886 975611183
Fax 74238 0
Email 74238 0
[email protected]
Contact person for public queries
Name 74239 0
Chen-Chen Wang
Address 74239 0
Research Assistant Center, Show Chwan Memorial Hospital
542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Country 74239 0
Taiwan, Province Of China
Phone 74239 0
+886 975611854
Fax 74239 0
Email 74239 0
[email protected]
Contact person for scientific queries
Name 74240 0
Chun-Yi Lin
Address 74240 0
Department of Nuclear Medicine, Show Chwan Memorial Hospital
542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Country 74240 0
Taiwan, Province Of China
Phone 74240 0
+886 975611183
Fax 74240 0
Email 74240 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.