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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02153385
Other study ID # KMU-Q099012
Secondary ID
Status Completed
Phase N/A
First received May 19, 2014
Last updated June 2, 2014
Start date September 2010
Est. completion date June 2011

Study information

Verified date June 2014
Source Kaohsiung Medical University
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Background: Women are more likely to suffer from depression and anxiety, which have been linked to reduced heart rate variability (HRV) and increased cardiovascular morbidity and mortality. The purpose of this study was to examine the effects of an 8-week yoga program on HRV and mood in generally healthy women. The investigators hypothesized that there would be improvements in HRV and reductions in perceived stress and symptoms of depression and anxiety after the yoga intervention.

Methods: Fifty-two healthy women were randomized to either a yoga group or a control group. Participants in the yoga group completed an 8-week yoga program, which comprised a 60-minute session, twice a week. Each session consisted of breathing exercises, yoga pose practice, and supine meditation/relaxation. Participants' HRV, perceived stress, depressive symptoms, and state and trait anxiety were assessed at baseline and week 9.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- women

- aged 18-50 years old

- body mass index < 30 kg/m2

Exclusion Criteria:

- currently engaged in regular yoga practice

- pregnant

- nursing

- had physical contraindications to exercise

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Yoga
Yoga program was 60 min per session, twice per week for 8 weeks. Led by an experienced yoga instructor.

Locations

Country Name City State
Taiwan Kaohsiung Medical University Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in heart rate variability at week 9 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). Participants were instructed to avoid exercise one day before the assessment session and abstain from caffeinated food and beverages on the day of assessment. During the assessment, participants were instructed to relax in a supine position with no other tasks or stimulation for 20 minutes while the ECG was recording. The last 10 minutes of the ECG recording was analyzed for HRV. R-R intervals were computed and the HRV power spectrum was obtained via a fast Fourier transformation algorithm using an appropriate software program (HRV Analysis for Windows, version 1.1; Biosignal Imaging Group and Analysis, the University of Kuopio, Kuopio, Finland). The ourcome measure was assessed at baseline and at week 9 No
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