Breath, Stress and Health: a Biocultural Study of Hatha Yoga Practice

NCT03856892 | Completed

• 1 other identifier: IRB00107267
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to contribute uniquely to stress, longevity, and mental health research in two ways: by identifying clear protocols of breath-based yoga-meditative practice based on original materials; that are subsequently assessed with established scientific stress, biochemical immunity and longevity markers, and validated psychological measures that relate to mental health.

Conditions

Stress, Physiological; Stress, Psychological

Keywords

Yoga; Breath-based yoga; Stress management; Meditation; Hatha yoga; Anxiety mitigation; Mental health; Longevity

Outcome Measures

Primary Outcomes (1)

• Change in Heart Rate Variability (HRV) Between Study Arms

  Heart rate variability (HRV) is measured by electrocardiogram.

  Baseline, up to 6 months

Secondary Outcomes (38)

• Change in Heart Rate Variability (HRV) Between High and Low Participation Level

  Baseline, up to 6 months

• Change in Skin Conductance Level (SCL) Between Study Arms

  Baseline, up to 6 months

• Change in Skin conductance level (SCL) Between High and Low Participation Level

  Baseline, up to 6 months

• Change in Skin Conductance Response Between Study Arms

  Baseline, up to 6 months

• Change in Skin Conductance Response Between High and Low Participation Level

  Baseline, up to 6 months

Other Outcomes (5)

• Change in Brain-derived Neurotrophic Factor (BDNF) Level in Blood Serum Between Study Arms

  Baseline, up to 6 months

• Change in Growth Hormone Level in Blood Serum Between Study Arms

  Baseline, up to 6 months

• Change in Oxytocin Level in Blood Serum Between Study Arms

  Baseline, up to 6 months

Study Arms (3)

Active Study Group

EXPERIMENTAL

Participants randomized to the Active Study Group are asked to follow a daily routine of the three protocols of psycho-physical yoga component techniques: Slow Engaged Dynamic Asana (SEDA), Breath Regulated Engaged Meditation (BREM), Sound Heart Engaged Meditation (SHEM). This intervention involves more hours in daily practice to equate to a "high dose" of breath and meditative techniques.

Other: High Dose Yoga

Active Control

ACTIVE COMPARATOR

Participants randomized to the Active Control study arm are asked to follow a daily routine of low-to mid-intensity body posture practice that is body-based and has minimal breath or meditative elements. This intervention involves fewer hours in daily practice to equate to a "medium dose" of body focused techniques

Other: Medium Dose Yoga

Passive Control

NO INTERVENTION

Participants randomized to the Passive Control study arm do not receive a study intervention.

Interventions

High Dose Yoga OTHER

Participants engage in an intensive full yoga practice of hatha breath-based practices and inner meditative techniques along with body-based asana. Intensive level uses breath, management of abdomen, inner focus in all practices. The "high dose" of yoga is an interpretation of the Translational Model of Yoga (TMY) and Yoga Process formula, both developed in this study's cultural research: a systematized psycho-physical yoga method of Hatha Zone (HZ) focus (below-navel, exhale, inner focus), incorporating key components of practice-focus-surrender (PFS) approach and repeat-engage-trust (RET) elements.

Active Study Group

Medium Dose Yoga OTHER

The "medium dose" of yoga is a regular practice of primarily body-posture training with minimal reference to the breath, but with a longer period of time duration in training prior to intervention commencement. Participants have 5 months of pre-training before initiating the intervention.

Active Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Novice to breath-based yoga practice
• Multicultural international participant base
• Fluent in English comprehension and reading
• In general good health
• Have a smartphone or similar device in order to receive surveys on a dedicated app

You may not qualify if:

• none

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Kaivalyadhama Yoga Institute

Lonavla, Maharashtra, 410403, India

Location

MeSH Terms

Conditions

Stress, Psychological; Psychological Well-Being

Interventions

Yoga

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Paul Dallaghan, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anthropology

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: February 27, 2019
• Study Start: January 11, 2019
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available for sharing beginning immediately and ending 3 years after publication of the results from this study.
• Access Criteria: Data will be available for sharing with researchers who provide a methodologically sound proposal, for the purposes of achieving the aims of the approved proposal. Proposals should be directed to paul.dallaghan@cuanschutz.edu. To gain access, requestors will need to sign a data access agreement.

Locations

IN (1)