Trial Review

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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
Scientific title
Effects of yoga training on depressive symptoms and heart rate variability in sedentary women with depression
Secondary ID [1] 284907 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive symptoms 292371 0
Heart rate variability 292372 0
Condition category
Condition code
Mental Health 292688 292688 0 0
Depression
Alternative and Complementary Medicine 292730 292730 0 0
Other alternative and complementary medicine
Cardiovascular 292731 292731 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 289725 0
Treatment: Other
Intervention code [2] 289762 0
Lifestyle
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.
Control group
Active

Outcomes
Primary outcome [1] 292533 0
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).
Timepoint [1] 292533 0
baseline and week 13
Secondary outcome [1] 309163 0
Depressive symptoms were assessed using Beck Depression Inventory-II (BDI-II).
Timepoint [1] 309163 0
baseline and week 13

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).
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No involvement in regular exercise or yoga practice.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2011
Actual
1/10/2011
Date of last participant enrolment
Anticipated
30/06/2012
Actual
1/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment outside Australia
Country [1] 6190 0
Taiwan, Province Of China
State/province [1] 6190 0

Funding & Sponsors
Funding source category [1] 289532 0
Government body
Name [1] 289532 0
Ministry of Science and Technology
Country [1] 289532 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
I-Hua Chu
Address
Kaohsiung Medical University, 100, Shih-Chuan 1st Road, San Ming District, Kaohsiung 807, Taiwan
Country
Taiwan, Province Of China
Secondary sponsor category [1] 288219 0
None
Name [1] 288219 0
Address [1] 288219 0
Country [1] 288219 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291273 0
Kaohsiung Medical University Chung-Ho Memorial Hospital Institutional Review Board
Ethics committee address [1] 291273 0
No.100 , Tzyou 1st Road Kaohsiung 807 , Taiwan
Ethics committee country [1] 291273 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 291273 0
16/05/2011
Approval date [1] 291273 0
23/08/2011
Ethics approval number [1] 291273 0
KMUH-IRB-20110171

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.
Trial website
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.
Public notes

Contacts
Principal investigator
Name 49626 0
Prof I-Hua Chu
Address 49626 0
Kaohsiung Medical University, 100, Shih-Chuan 1st Road, Kaohsiung City, 807
Country 49626 0
Taiwan, Province Of China
Phone 49626 0
+886-7-3121101 ext 2646
Fax 49626 0
Email 49626 0
[email protected]
Contact person for public queries
Name 49627 0
I-Hua Chu
Address 49627 0
Kaohsiung Medical University, 100, Shih-Chuan 1st Road, Kaohsiung City, 807
Country 49627 0
Taiwan, Province Of China
Phone 49627 0
+886-7-3121101 ext 2646
Fax 49627 0
Email 49627 0
[email protected]
Contact person for scientific queries
Name 49628 0
I-Hua Chu
Address 49628 0
Kaohsiung Medical University, 100, Shih-Chuan 1st Road, Kaohsiung City, 807
Country 49628 0
Taiwan, Province Of China
Phone 49628 0
+886-7-3121101 ext 2646
Fax 49628 0
Email 49628 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.