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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01866683
Other study ID # 184.583
Secondary ID
Status Completed
Phase N/A
First received May 23, 2013
Last updated June 11, 2015
Start date January 2013
Est. completion date March 2014

Study information

Verified date June 2015
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical 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 and salivary cortisol (stress hormone).


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 45 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
1 month respiratory training
Bhastrika yoga respiratory training: 30 kapalabhati and 1 surya bedhana form 1 bhastrika
1 month waiting period
waiting or detraining period

Locations

Country Name City State
Brazil Universidade Federal do Rio Grande do Norte - UFRN Natal Rio Grande do Norte

Sponsors (2)

Lead Sponsor Collaborator
University of Sao Paulo Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes from baseline electroencephalography measures of brain waves at 1 and 2 months 64 active electrodes electroencephalography baseline, one month, two months No
Secondary frequency domain heart rate variability R-R interval autoregressive spectral analysis study entry, one month, two months No
Secondary salivary cortisol study entry, one month, two months No
Secondary quality of life 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 No
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