NCT01866683

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

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

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

June 15, 2015

Status Verified

June 1, 2015

Enrollment Period

1.2 years

First QC Date

May 23, 2013

Last Update Submit

June 11, 2015

Conditions

Health BehaviorQuality of Life

Keywords

YogaElectroencephalographyHeart rate variabilityBreathing ExercisesQuality of life

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline electroencephalography measures of brain waves at 1 and 2 months

    64 active electrodes electroencephalography

    baseline, one month, two months

Secondary Outcomes (3)

  • frequency domain heart rate variability

    study entry, one month, two months

  • salivary cortisol

    study entry, one month, two months

  • quality of life

    study entry, one month, two months

Study Arms (2)

Group 1

EXPERIMENTAL

1 month respiratory training

Behavioral: 1 month respiratory trainingBehavioral: 1 month waiting period

Group 2

EXPERIMENTAL

1 month waiting period

Behavioral: 1 month respiratory trainingBehavioral: 1 month waiting period

Interventions

1 month respiratory trainingBEHAVIORAL

Bhastrika yoga respiratory training: 30 kapalabhati and 1 surya bedhana form 1 bhastrika

Group 1Group 2
1 month waiting periodBEHAVIORAL

waiting or detraining period

Group 1Group 2

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young adults;
  • Physically fit (engaged in physical activity at least 2-3 times a week);
  • Non athletes;
  • Possibility to follow protocol agenda.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio Grande do Norte - UFRN

Natal, Rio Grande do Norte, 59078-970, Brazil

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Danilo F Santaella, Ph.D.

    University of São Paulo and Federal University of Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

May 23, 2013

First Posted

May 31, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

June 15, 2015

Record last verified: 2015-06

Locations

BR(1)