Heart Rate VariabilityNCT02153385
Effects of Yoga on Heart Rate Variability and Mood in Women
A study testing Yoga in people with Heart Rate Variability, run by Kaohsiung Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Variability
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women
- aged 18-50 years old
- body mass index < 30 kg/m2
Who cannot join
- currently engaged in regular yoga practice
- pregnant
- nursing
- had physical contraindications to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Yoga on Heart Rate Variability and Mood in Women: A Randomized Controlled Trial
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.
- Conditions
- Heart Rate Variability
- Being tested
- Yoga
- Keywords
- Yoga, heart rate variability, stress, mood, women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
Yoga program was 60 min per session, twice per week for 8 weeks. Led by an experienced yoga instructor.
| Study group | Role | What they receive |
|---|---|---|
| Yoga group | Experimental | Two yoga sessions per week for 8 weeks Receives: Other: Yoga |
| Control group | No intervention | Usual level of physical activity; no involvement in any yoga practice during the course of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The ourcome measure was assessed at baseline and at week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startSep 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate VariabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I-Hua Chu, PT, PhD, Kaohsiung Medical University
- Investigators
- I-Hua Chu, PhD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153385
- Sponsor's protocol ID
- KMU-Q099012
- Status last verified
- Jun 2014
- First submitted
- 19 May 2014
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yoga on Heart Rate Variability and Mood in Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02153385
- Acronym / sponsor ID
- KMU-Q099012
- Conditions
- Heart Rate Variability
- Keywords
- Yoga, heart rate variability, stress, mood, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga group | Experimental | Other: YogaTwo yoga sessions per week for 8 weeks |
| Control group | No intervention | –Usual level of physical activity; no involvement in any yoga practice during the course of the study |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women
- aged 18-50 years old
- body mass index < 30 kg/m2
Key exclusion criteria (4 listed)
- currently engaged in regular yoga practice
- pregnant
- nursing
- had physical contraindications to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaYoga program was 60 min per session, twice per week for 8 weeks. Led by an experienced yoga instructor. | Other | Yoga group |
Primary outcome
Change from baseline in heart rate variability at week 9
Time frame: The ourcome measure was assessed at baseline and 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I-Hua Chu, PhD principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Heart Rate Variability, run by Kaohsiung Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in heart rate variability at week 9 (time frame: The ourcome measure was assessed at baseline and at week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2014.