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Trial registered on ANZCTR
Registration number
ACTRN12614000733673
Ethics application status
Approved
Date submitted
2/07/2014
Date registered
10/07/2014
Date last updated
10/07/2014
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effects of yoga on depressive symptoms and cardiac autonomic control in women
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Scientific title
Effects of yoga training on depressive symptoms and heart rate variability in sedentary women with depression
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Secondary ID [1]
284907
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depressive symptoms
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Heart rate variability
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Condition category
Condition code
Mental Health
292688
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0
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Depression
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Alternative and Complementary Medicine
292730
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0
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Other alternative and complementary medicine
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Cardiovascular
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0
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Normal development and function of the cardiovascular system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Sedentary women scoring 14 or higher on the Beck Depression Inventory-II (BDI-II) were randomized to either yoga group or wait-list control group. Participants in the yoga group enrolled in a 60 minutes yoga session, twice per week for 12 weeks. The yoga program incorporated pranayama (breathing exercise), asana (postures), and savasana (meditation/relaxation), and was group-based and led by an experienced yoga instructor.
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Intervention code [1]
289725
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Treatment: Other
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Intervention code [2]
289762
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Lifestyle
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Comparator / control treatment
The control group was instructed not to engage in any yoga practice and to maintain their usual level of physical activity. After completing the post-test, participants in the control group were provided a free 12-week yoga program.
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Control group
Active
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Outcomes
Primary outcome [1]
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Heart rate variability analysis was derived from continuous heart rate recording, at a sampling rate of 1024 Hz, using an electrocardiogram (ECG) system (MP 150, BIOPAC Systems, Goleta, CA, USA).
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Assessment method [1]
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Timepoint [1]
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baseline and week 13
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Secondary outcome [1]
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Depressive symptoms were assessed using Beck Depression Inventory-II (BDI-II).
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Assessment method [1]
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Timepoint [1]
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baseline and week 13
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Eligibility
Key inclusion criteria
Women with a Beck Depression Inventory score of 14 or greater. To participate in the study, women also have to be sedentary (i.e., exercising less than three times per week for less than 20 minutes per session).
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
No involvement in regular exercise or yoga practice.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were volunteers recruited from university campus and the surrounding community. An experimenter not involved in data collection and intervention prepared the randomization assignments and informed the participants their group assignments upon the completion of baseline testing.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were randomized to the yoga group or the control group via computer-generated random allocation sequence by simple randomization.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Two way repeated measures ANOVA
The sample size needed for this study was calculated based on the results of previous meta-analyses on exercise and depression in clinical populations (Craft & Landers, 1998;
Lawlor & Hopker, 2001). The calculated total sample size to detect a significant difference between treatment groups on changes in BDI-II scores was 34 (i.e., 17 participants in each
group) with an alpha level of 0.05, a power of 0.8, and an effect size of 0.5. The sample size was calculated using a computer software – GPOWER (Erdfelder, Faul, & Buchner, 1996).
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/10/2011
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Actual
1/10/2011
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Date of last participant enrolment
Anticipated
30/06/2012
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Actual
1/09/2012
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
34
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Taiwan, Province Of China
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State/province [1]
6190
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Ministry of Science and Technology
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Address [1]
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106, Sec. 2, Heping E. Rd., Taipei 10622, Taiwan, R.O.C.
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Country [1]
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Taiwan, Province Of China
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Primary sponsor type
Individual
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Name
I-Hua Chu
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Address
Kaohsiung Medical University, 100, Shih-Chuan 1st Road, San Ming District, Kaohsiung 807, Taiwan
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Country
Taiwan, Province Of China
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
288219
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Kaohsiung Medical University Chung-Ho Memorial Hospital Institutional Review Board
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Ethics committee address [1]
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No.100 , Tzyou 1st Road Kaohsiung 807 , Taiwan
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Ethics committee country [1]
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Taiwan, Province Of China
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Date submitted for ethics approval [1]
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16/05/2011
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Approval date [1]
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23/08/2011
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Ethics approval number [1]
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KMUH-IRB-20110171
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Summary
Brief summary
The purpose of this study was to investigate the effects of a 12-week yoga program on depressive symptoms and cardiac autonomic control in women. We hypothesized that after 12 weeks of yoga training, depressive symptoms would be reduced and cardiac autonomic control would be improved.
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Trial website
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Trial related presentations / publications
The results of this trial will be presented in a symposium in the 7th Asian-South Pacific Association of Sport Psychology International Congress in Tokyo, Japan during the period from 7th to 10th August, 2014.
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Public notes
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Contacts
Principal investigator
Name
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Prof I-Hua Chu
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Address
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Kaohsiung Medical University, 100, Shih-Chuan 1st Road, Kaohsiung City, 807
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Country
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Taiwan, Province Of China
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Phone
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+886-7-3121101 ext 2646
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof I-Hua Chu
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Address
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Kaohsiung Medical University, 100, Shih-Chuan 1st Road, Kaohsiung City, 807
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Country
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Taiwan, Province Of China
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Phone
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+886-7-3121101 ext 2646
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof I-Hua Chu
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Address
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Kaohsiung Medical University, 100, Shih-Chuan 1st Road, Kaohsiung City, 807
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Country
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Taiwan, Province Of China
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Phone
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+886-7-3121101 ext 2646
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Fax
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Email
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[email protected]
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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.
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