NCT05330026

Brief Summary

INTRODUCTION The practice of yoga in recent years is becoming more common. Originating in India, yoga combines physical postures with a philosophy of life and breathing (pranayama). One of the breaths used during yoga practice is the so-called ujjayi or victorious breath. It consists of the voluntary contraction of the muscles of the larynx both in inspiration and expiration. This reduces the diameter of the larynx, reducing airflow and thus increasing intrathoracic pressure, as well as increasing expiratory/inspiratory time and reducing respiratory rate and dead space. It also increases oxygen saturation in healthy subjects, increasing respiratory effort. Several studies have verified the relationship between ujjayi breathing and increased BRS (cardiovagal baroreflex sensitivity), by stimulation of the parasympathetic system at the glottis level. This would favor a decrease in heart rate, as well as better control of stress and anxiety. The cardiovascular and respiratory effects studied with ujjayi breathing have not evaluated the effect that this breath has on the activation of the respiratory muscles, mainly the diaphragm. The diaphragm is the main inspiratory muscle and as such, lung volumes and intrathoracic pressures created during respiration depend on its activation and position. In recent years, ultrasound has become a technique widely used by pulmonologists and intensivists. It is an easy technique to perform, reproducible, non-ionizing, allows bilateral comparison, non-invasive and non-painful and whose results can broaden the information from other techniques such as spirometry and radiography. There are standardized protocols to measure the diaphragmatic excursion, the thickness of the diaphragm HYPOTHESIS: ujjayi breathing is capable of generating greater activation of the diaphragm in subjects healthy with respect to spontaneous or pursed-lip breathing. OBJECTIF: study and compare the activation and work of the diaphragm in different type of breathing (ujjayi, pursed lips and at rest) in healthy subjects who practice yoga or not. DESIGN: cross over study experimental, analytical and prospective. METHODOLOGY: 80 healthy subjets (40 yoga practitioners and 40 non yoga practitioners) participated at this study. All of them volunteers will undergo an ultrasound study of their diaphragm. To do this, following the stipulated protocol, three variables will be analyzed: diaphragm thickness, its rate of contraction, and diaphragmatic excursion, all of them at rest, ujjayi breathing, and pursed-lip breathing. The ultrasound measurements will be taken by a single researcher, who is not the main one, and who will not know which group each of the subjects belongs to, thus avoiding an evaluation bias. To avoid bias and according to the RUSI regulations, the researcher will take 3 measurements of each of the explorations with the average of the 3.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 15, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

February 4, 2022

Last Update Submit

April 19, 2022

Conditions

Keywords

breathingdiaphragmultrasound

Outcome Measures

Primary Outcomes (1)

  • Diaphragm thickness

    The assessment will be taken in the right hemidiaphragm since it is more accessible than the left through its hepatic window. To evaluate the thickness the investigators will use a linear probe at 10-12MHz, placing it perpendicular to the intercostal space between the 9th and 10th rib, in the anterior part of the axillary line. At this level, 3 parallel layers with different echogenicity corresponding to the pleura, diaphragm and peritoneum will be observed. The distance between the inner edge of the pleural line and the inner edge of the peritoneal line will be measured.

    Baseline, end maximal inspiration

Secondary Outcomes (2)

  • Diaphragm excursion

    Baseline, end maximal inspiration

  • Activation speed

    Baseline, end maximal inspiration

Study Arms (2)

Yoga practitioner

EXPERIMENTAL

The RUSI protocol for taking measurements with ultrasound for physiotherapists will be followed. Three measurements of each of the explorations will be made with the average of the three, pausing for 30 seconds between each repetition. Three variables will be analyzed: diaphragm thickness, its rate of contraction, and diaphragmatic excursion, all of them at rest, ujjayi breathing, and pursed-lip breathing.

Combination Product: Diaphragm´s study during yoga breathing

Non yoga practitioner

ACTIVE COMPARATOR

Each subject will have previously received (one week before taking the measurements) the instructions where the main researcher will have shown him what calm diaphragmatic breathing is like, as well as forced breathing at maximum inspired volume with neutral breathing, yoga breathing (ujjayi ) and pursed-lip breathing. During that week prior to taking measurements, the subjects should practice each breath for 20 minutes a day in order to have a good awareness of how to perform them correctly. The RUSI protocol for taking measurements with ultrasound for physiotherapists will be followed. Three measurements of each of the explorations will be made with the average of the three, pausing for 30 seconds between each repetition. Three variables will be analyzed: diaphragm thickness, its rate of contraction, and diaphragmatic excursion, all of them at rest, ujjayi breathing, and pursed-lip breathing.

Combination Product: Diaphragm´s study during yoga breathing

Interventions

Study and compare the activation of the diaphragm during different breaths: rest, ujjayi and pursed lips

Non yoga practitionerYoga practitioner

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yoga practitioners for more than a year

You may not qualify if:

  • respiratory pathology
  • thoracic deformities
  • neuromuscular diseases
  • Under treatment with corticosteroids, muscle relaxants and/or barbiturates
  • allergic episodes in the last 3 weeks
  • thoracic or abdominal surgeries in the last 3 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Autónoma de Madrid

Madrid, 29049, Spain

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Teresa E Fernandez Pardo, PT, Msc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 4, 2022

First Posted

April 15, 2022

Study Start

January 15, 2022

Primary Completion

June 1, 2022

Study Completion

September 1, 2022

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

All the researchers will participate in all the study phases

Locations