NCT02153385

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
Last Updated

June 4, 2014

Status Verified

June 1, 2014

Enrollment Period

9 months

First QC Date

May 19, 2014

Last Update Submit

June 2, 2014

Conditions

Keywords

Yoga, heart rate variability, stress, mood, women

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Yoga group

EXPERIMENTAL

Two yoga sessions per week for 8 weeks

Other: Yoga

Control group

NO INTERVENTION

Usual level of physical activity; no involvement in any yoga practice during the course of the study

Interventions

YogaOTHER

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

Yoga group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women
  • aged 18-50 years old
  • body mass index \< 30 kg/m2

You may not qualify if:

  • currently engaged in regular yoga practice
  • pregnant
  • nursing
  • had physical contraindications to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • I-Hua Chu, PhD

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 19, 2014

First Posted

June 3, 2014

Study Start

September 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 4, 2014

Record last verified: 2014-06

Locations