- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01866683
Yoga Effects on Heart Rate Variability and Electroencephalography
June 11, 2015 updated by: Danilo Forghieri Santaella, University of Sao Paulo
Effects of Yoga on Heart Rate Variability, Electroencephalography, Quality of Life and Salivary Cortisol of Healthy Adult Subjets
Since yoga breathing exercises are traditionally used to tranquilize the mind, and have a well-known positive effect on the cardiovascular system, it is our hypothesis that a respiratory yoga exercise named bhastrika pranayama may have positive effects on heart rate variability, electroencephalography, quality of life and salivary cortisol (stress hormone).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The effects of yoga interventions on heart rate variability have been previously shown in our laboratory, having its efficacy in improving autonomic heart modulation of hypertensives and elderly subjets proven.
However, there is a lack of data addressing the effects of such interventions on EEG patterns of health fit male subjects, as well as there are no study investigating if there is a relationship between heart autonomic modulation changes and EEG patterns.
Thus, the aim of this study was to investigate the effects of 1 month respiratory yoga training on heart rate variability, EEG, salivary cortisol and quality of life of health fit male subjets.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande do Norte
-
Natal, Rio Grande do Norte, Brazil, 59078-970
- Universidade Federal do Rio Grande do Norte - UFRN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Young adults;
- Physically fit (engaged in physical activity at least 2-3 times a week);
- Non athletes;
- Possibility to follow protocol agenda.
Exclusion Criteria:
- Epileptic events in previous 5 years;
- Chronic allergic rhinitis, with airway occlusion;
- Oral bronchodilator usage;
- Beta blocker user;
- Any diagnosed cardiac rhythm alteration at rest;
- Cerebral dysrhythmia;
- Previous training in respiratory yoga exercises.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
1 month respiratory training
|
Bhastrika yoga respiratory training: 30 kapalabhati and 1 surya bedhana form 1 bhastrika
waiting or detraining period
|
|
Experimental: Group 2
1 month waiting period
|
Bhastrika yoga respiratory training: 30 kapalabhati and 1 surya bedhana form 1 bhastrika
waiting or detraining period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes from baseline electroencephalography measures of brain waves at 1 and 2 months
Time Frame: baseline, one month, two months
|
64 active electrodes electroencephalography
|
baseline, one month, two months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
frequency domain heart rate variability
Time Frame: study entry, one month, two months
|
R-R interval autoregressive spectral analysis
|
study entry, one month, two months
|
|
salivary cortisol
Time Frame: study entry, one month, two months
|
study entry, one month, two months
|
|
|
quality of life
Time Frame: study entry, one month, two months
|
quality of life will be addressed by the World Health Organization Questionaire of Quality of Life in its brief form
|
study entry, one month, two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Danilo F Santaella, Ph.D., University of São Paulo and Federal University of Rio Grande do Norte
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
May 23, 2013
First Submitted That Met QC Criteria
May 28, 2013
First Posted (Estimate)
May 31, 2013
Study Record Updates
Last Update Posted (Estimate)
June 15, 2015
Last Update Submitted That Met QC Criteria
June 11, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 184.583
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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