Health BehaviorNCT01866683
Yoga Effects on Heart Rate Variability and Electroencephalography
A study testing 1 month respiratory training and 1 month waiting period in people with Health Behavior and Quality of Life, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Quality of Life
- What is being tested?
- 1 month respiratory training and 1 month waiting period
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Mar 2014
- 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 25 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young adults;
- Physically fit (engaged in physical activity at least 2-3 times a week);
- Non athletes;
- Possibility to follow protocol agenda.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande do Norte - UFRN
Natal, Rio Grande do Norte, 59078-970
About this study
Official title: 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).
Read the 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.
- Conditions
- Health Behavior, Quality of Life
- Being tested
- 1 month respiratory training, 1 month waiting period
- Keywords
- Yoga, Electroencephalography, Heart rate variability, Breathing Exercises, Quality of life
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 month respiratory trainingBehavioural
Bhastrika yoga respiratory training: 30 kapalabhati and 1 surya bedhana form 1 bhastrika
1 month waiting periodBehavioural
waiting or detraining period
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 1 month respiratory training Receives: Behavioral: 1 month respiratory training; Behavioral: 1 month waiting period |
| Group 2 | Experimental | 1 month waiting period Receives: Behavioral: 1 month respiratory training; Behavioral: 1 month waiting period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline electroencephalography measures of brain waves at 1 and 2 months
64 active electrodes electroencephalography
Measured: baseline, one month, two months
Secondary outcomes (3)
frequency domain heart rate variability
R-R interval autoregressive spectral analysis
Measured: study entry, one month, two months
salivary cortisol
Measured: study entry, one month, two months
quality of life
quality of life will be addressed by the World Health Organization Questionaire of Quality of Life in its brief form
Measured: study entry, one month, two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Danilo Forghieri Santaella, University of Sao Paulo
- Investigators
- Danilo F Santaella, Ph.D., Principal investigator, University of São Paulo and Federal University of Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866683
- Sponsor's protocol ID
- 184.583
- Status last verified
- Jun 2015
- First submitted
- 23 May 2013
- Last updated
- 15 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yoga on Heart Rate Variability, Electroencephalography, Quality of Life and Salivary Cortisol of Healthy Adult Subjets
- ClinicalTrials.gov ID
- NCT01866683
- Acronym / sponsor ID
- 184.583
- Conditions
- Health Behavior, Quality of Life
- Keywords
- Yoga, Electroencephalography, Heart rate variability, Breathing Exercises, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jan 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 31 May 2013 (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.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: 1 month respiratory training, Behavioral: 1 month waiting period1 month respiratory training |
| Group 2 | Experimental | Behavioral: 1 month respiratory training, Behavioral: 1 month waiting period1 month waiting period |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Young adults;
- Physically fit (engaged in physical activity at least 2-3 times a week);
- Non athletes;
- Possibility to follow protocol agenda.
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| 1 month respiratory trainingBhastrika yoga respiratory training: 30 kapalabhati and 1 surya bedhana form 1 bhastrika | Behavioural | Group 1, Group 2 |
| 1 month waiting periodwaiting or detraining period | Behavioural | Group 1, Group 2 |
Primary outcome
Changes from baseline electroencephalography measures of brain waves at 1 and 2 months
Time frame: baseline, one month, two months
64 active electrodes electroencephalography
3 secondary outcomes
frequency domain heart rate variability
Time frame: study entry, one month, two months
salivary cortisol
Time frame: study entry, one month, two months
quality of life
Time frame: study entry, one month, two months
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 15 Jun 2015.
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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.
Danilo F Santaella, Ph.D. principal investigator
University of São Paulo and Federal University of Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 month respiratory training and 1 month waiting period in people with Health Behavior and Quality of Life, run by University of Sao Paulo at 1 site in Brazil.
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 4 inclusion and 7 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 15 Jun 2015. 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 Brazil. 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?
Changes from baseline electroencephalography measures of brain waves at 1 and 2 months (time frame: baseline, one month, two months). 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 15 Jun 2015.