YogaNCT05330026
Ultrasound Imaging of the Diaphragm During Yoga Breathing
A study testing Diaphragm´s study during yoga breathing in people with Yoga, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Yoga
- What is being tested?
- Diaphragm´s study during yoga breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2022to Sep 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- yoga practitioners for more than a year
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Autónoma de Madrid
Madrid, 29049
Teresa E Fernandez Pardo, PT, Msc, 0034650193112, teresaemilia.fernandez@estudiante.uam.es
About this study
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.
Read more
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.
- Conditions
- Yoga
- Being tested
- Diaphragm´s study during yoga breathing
- Keywords
- breathing, diaphragm, ultrasound
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm´s study during yoga breathingCombination product
Study and compare the activation of the diaphragm during different breaths: rest, ujjayi and pursed lips
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: Diaphragm´s study during yoga breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, end maximal inspiration
Secondary outcomes (2)
Diaphragm excursion
The distance it makes in inspiration will be measured, when it contracts and descends. A 2.5 to 3.5 MHz convex probe will be used.
The probe will be positioned firmly below the right costal arch and on the line corresponding to the middle of the clavicle, orienting it cranially. The investigators will visualize the dome of the right hemidiaphragm that appears as a thick hyperechoic line. The investigators look for the highest diaphragmatic position, which is the part of the diaphragm that produces the greatest cranial-caudal excursion. The M mode modality will be activated, which provides us with the pattern of diaphragmatic movement.
It will be measured from the highest point of the diaphragmatic dome (end expiration, in functional residual capacity) to the lowest point achieved at the end of each inspiration.
Measured: Baseline, end maximal inspiration
Activation speed
It is an indirect measurement that is calculated by dividing the diaphragm amplitude in cm by the inspiratory time in seconds. Will be measured with TM mode
Measured: Baseline, end maximal inspiration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start15 Jan 2022
- Primary completionJun 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for YogaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Emilia Fernandez Pardo, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330026
- Sponsor's protocol ID
- CEI-120- 2409
- Status last verified
- Apr 2022
- First submitted
- 4 Feb 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the researchers will participate in all the study phases
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Imaging of the Diaphragm During Yoga Breathing
- ClinicalTrials.gov ID
- NCT05330026
- Acronym / sponsor ID
- CEI-120- 2409
- Conditions
- Yoga
- Keywords
- breathing, diaphragm, ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 15 Apr 2022 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga practitioner | Experimental | Combination Product: Diaphragm´s study during yoga breathingThe 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. |
| Non yoga practitioner | Active comparator | Combination Product: Diaphragm´s study during yoga breathingEach 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- yoga practitioners for more than a year
Key exclusion criteria (6 listed)
- respiratory pathology
- thoracic deformities
- neuromuscular diseases
- Under treatment with corticosteroids, muscle relaxants and/or barbiturates
- allergic episodes in the last 3 weeks
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 |
|---|---|---|
| Diaphragm´s study during yoga breathingStudy and compare the activation of the diaphragm during different breaths: rest, ujjayi and pursed lips | Combination product | Non yoga practitioner, Yoga practitioner |
Primary outcome
Diaphragm thickness
Time frame: Baseline, end maximal inspiration
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.
2 secondary outcomes
Diaphragm excursion
Time frame: Baseline, end maximal inspiration
Activation speed
Time frame: Baseline, end maximal inspiration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No. All the researchers will participate in all the study phases
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragm´s study during yoga breathing in people with Yoga, run by Universidad Autonoma de Madrid at 1 site in Spain.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Apr 2022. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresa E Fernandez Pardo, PT, Msc (0034650193112, teresaemilia.fernandez@estudiante.uam.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm thickness (time frame: Baseline, end maximal inspiration). 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 27 Apr 2022.