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Spinal Cord InjuriesNCT06514950

Yoga Breath Training to Improve Cardiorespiratory Synchrony in Spinal Cord Injury

A study testing Ujjayi Yogic Breathing in people with Spinal Cord Injuries, run by Spaulding Rehabilitation Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this interventional study is to understand how regular yogic breathing practice, particularly a slow resistive yogic breathing technique called Ujjayi, would benefit individuals between the ages of 18 and 60 with spinal cord injuries. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Ujjayi Yogic Breathing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Aug 2024to 1 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Spinal cord injury
  • American Spinal Injury Association Impairment Scale (AIS) score of A, B, or C
  • Aged 18-60 years
  • Wheelchair user
  • Medically stable and able to follow directions
  • Body mass index of 18.5 - 35 kg/m2

Who cannot join

  • Resting blood pressure of >140/90 mmHg
  • Current use of tobacco or cardioactive medications (except medication to support blood pressure)
  • Significant arrhythmia
  • Bleeding disorder
  • Pulmonary disease
  • Coronary artery disease
Show all 12Show fewer
  • Diabetes
  • Renal disease
  • Cancer
  • Epilepsy or other neurological diseases
  • Current use of CPAP/BIPAP
  • Has smartphone or device incompatible with the PranaTM application

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

J. Andrew Taylor, MS, PhD contact

617-758-5503

jandrew_taylor@hms.harvard.edu

Maria Sukhoplyasova, BSc contact

617-758-5506

msukhoplyasova@partners.org

United States1 site, 1 recruiting
  • Spaulding Rehabilitation Hospital

    Cambridge, Massachusetts, 02138

    Glen Picard, MS, 617-758-5511, GPICARD@PARTNERS.ORG

    Recruiting

Other trials in United States

About this study

The goal of this interventional study is to understand how regular yogic breathing practice, particularly a slow resistive yogic breathing technique called Ujjayi, would benefit individuals between the ages of 18 and 60 with spinal cord injuries. Previously yogic breathing has shown to improve respiratory function and sleep- we'd like to explore this further.

The main questions this study aims to answer are:

Read more
  • How does Ujjayi breathing affect breathing patterns in individuals with spinal cord injuries?
  • How does Ujjayi breathing affect lung function in individuals with spinal cord injuries?
  • How does Ujjayi breathing affect the part of the nervous system responsible for ventilatory control in individuals with spinal cord injuries?
  • How does Ujjayi breathing affect ventilatory perfusion (how well air and blood flow match in the lungs for efficient gas exchange) in individuals with spinal cord injuries?
  • How does Ujjayi breathing affect sleep quality in individuals with spinal cord injuries?

Participants will undergo six weeks of training in Ujjayi breathing. Before and after this period, they will visit the lab for measurements of blood pressure, pulse, blood oxygen levels, and breathing. They will also perform several tests:

  • Pulmonary function testing to assess lung capacity and respiratory muscle strength.
  • Pace breathing frequency to four pre-recorded audio files at various breathing rates.
  • Breathing exercises involving higher levels of carbon dioxide for a short time.
  • Breathing exercises involving lower levels of oxygen for a short time.
  • At-home sleep evaluation.

Between the two laboratory testing sessions, participants will practice yogic resistance breathing (Ujjayi breathing) for six weeks.

Read the detailed description

This study investigates the impact of a type of slow-resistive yogic breathing, Ujjayi Pranayama, on cardiopulmonary function in 20 men and women aged 18-60 with spinal cord injuries classified under the American Spinal Injury Association Impairment Scale (AIS) score of A, B, or C. Participants will undergo baseline and post-intervention laboratory assessments over six weeks at Spaulding Hospital Cambridge, with cardiovascular and respiratory measurements taken during controlled and uncontrolled breathing conditions. Ujjayi Pranayama training, focusing on resistance breathing during exhalation and inhalation, will include coaching sessions in weeks 1 and 4, supplemented by virtual support for home practice (~20 min, twice daily). The study aims to determine whether regular yogic breathing practice enhances sleep quality, hypercapnic ventilatory response, and overall cardiopulmonary synchrony, potentially reducing respiratory and cardiovascular risks associated with SCI.

Being tested
Ujjayi Yogic Breathing
Keywords
SCI, Ujjayi, yogic breathing, pranayama
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ujjayi Yogic BreathingBehavioural

    Also called resistive breathing

    Participants will undergo 6 weeks of resistive yogic breathing (Ujjayi) upon exhalation (first three weeks) and upon inhalation and exhalation (second three weeks).

Study groups in NCT06514950
Study groupRoleWhat they receive
Ujjayi yogic breathing trainingExperimentalThis study will be a small (N = 20) prospective cohort study with a single unblinded intervention of Ujjayi resistance breathing.
Receives: Behavioral: Ujjayi Yogic Breathing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ventilatory pattern after regular Ujjayi breathing

    Ventilatory patterns measured as rate and regularity by breathing belts (pneumobelts). A normal respiratory rate for an adult at rest is 12 to 18 breaths per minute.

    Measured: Change in ventilatory pattern, Time Frame: Baseline, Week 6

  2. Pulmonary function after regular Ujjayi breathing

    Pulmonary function measured by spirometry, maximal voluntary ventilation, and maximum inspiratory and expiratory pressures. Results will be reported as forced vital capacity (FVC), Forced Expiratory Volume in 1 second (FEV1), FEV1/FVC ratio, Peak Expiratory Flow (PEF), and Forced Expiratory Flow (FEF) 25%-75%. An absolute range cannot be provided as it depends on various factors such as injury level, completeness of injury, age, race, and sex. In healthy adults, MVV is typically around 120-170 liters per minute (L/min).

    Measured: Change in pulmonary function, Time Frame: Baseline, Week 6

  3. Central and peripheral chemosensitivity after regular Ujjayi breathing

    The Read rebreathing method assesses neural drive to breathe and CO2 sensitivity (central chemosensitivity). A three-way valve connects the breathing circuit to room air or 95% O2-5% CO2. Subjects exhale to functional residual capacity, then rebreathe until PETCO2 reaches 55 mmHg, they can't continue, SPO2 drops below 95%, or 10 minutes elapse. Peripheral chemosensitivity uses brief exposures to hypercapnic (10% CO2, 21% O2) or hypoxic gas (pure nitrogen). Ventilatory response is measured over up to 30 seconds, followed by room air. Each test takes about 15 minutes. Tests are conducted seated and supine. Chemosensitivity is measured by plotting ventilation against pulmonary gas levels.

    Measured: Change in central and peripheral chemosensitivity, Time Frame: Baseline, Week 6

  4. Ventilatory perfusion after regular Ujjayi breathing

    Ventilatory perfusion will be calculated from mixed expired and end tidal CO2 measures. The V/Q ratio in healthy lungs is close to 1- this means that ventilation (V) matches perfusion (Q) almost perfectly in well-ventilated alveoli. Certain pathologies could increase or decrease the V/Q ratio.

    Measured: Change in ventilatory perfusion, Time Frame: Baseline, Week 6

  5. Sleep quality after regular Ujjayi breathing

    Sleep quality is assessed using two methods: the PROMIS Sleep Disturbance Short Form and NoxA1 polysomnography. The PROMIS survey provides raw scores that are converted into T-scores. T-scores falling between 40 and 59 indicate average sleep disturbance levels, considered within the normal range. Scores above 60 suggest more sleep disturbances than average, while scores below 39 indicate less disturbance compared to average.

    NoxA1 polysomnography records several parameters including EEG waves for sleep stages, wake after onset, nocturnal disturbances, maximum and minimum heart rates at rest, breathing rates, limb movements, teeth grinding (monitored via chin movement sensors), blood oxygen saturation, and respiratory patterns.

    Measured: Change in sleep quality, Time Frame: Baseline, Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2024
  2. Study start1 Aug 2024
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
This study is a small (N = 20) prospective cohort with a single unblinded intervention of Ujjayi resistance breathing at Spaulding Hospital Cambridge. Participants will have two lab visits: a baseline assessment and a post-intervention assessment six weeks later, each lasting about 4 hours. Cardiovascular and respiratory variables will be recorded during controlled and uncontrolled breathing. Coaching sessions in weeks 1 and 4 and virtual sessions via Zoom will train participants in the intervention, focusing on resistance breathing techniques. Participants will practice these techniques twice daily at home (\~20 min/day) over six weeks, totaling \~10 hours of in-person lab time.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06514950
Sponsor's protocol ID
2024P001385
Status last verified
Mar 2026
First submitted
17 Jul 2024
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shields RK. Muscular, skeletal, and neural adaptations following spinal cord injury. J Orthop Sports Phys Ther. 2002 Feb;32(2):65-74. doi: 10.2519/jospt.2002.32.2.65.

    PubMed 11838582
  • Zimmer MB, Nantwi K, Goshgarian HG. Effect of spinal cord injury on the respiratory system: basic research and current clinical treatment options. J Spinal Cord Med. 2007;30(4):319-30. doi: 10.1080/10790268.2007.11753947.

    PubMed 17853653
  • Tollefsen E, Fondenes O. Respiratory complications associated with spinal cord injury. Tidsskr Nor Laegeforen. 2012 May 15;132(9):1111-4. doi: 10.4045/tidsskr.10.0922. English, Norwegian.

    PubMed 22614314
  • Burns SP, Kapur V, Yin KS, Buhrer R. Factors associated with sleep apnea in men with spinal cord injury: a population-based case-control study. Spinal Cord. 2001 Jan;39(1):15-22. doi: 10.1038/sj.sc.3101103.

    PubMed 11224009
  • van den Berg ME, Castellote JM, de Pedro-Cuesta J, Mahillo-Fernandez I. Survival after spinal cord injury: a systematic review. J Neurotrauma. 2010 Aug;27(8):1517-28. doi: 10.1089/neu.2009.1138.

    PubMed 20486810
  • Waddimba AC, Jain NB, Stolzmann K, Gagnon DR, Burgess JF Jr, Kazis LE, Garshick E. Predictors of cardiopulmonary hospitalization in chronic spinal cord injury. Arch Phys Med Rehabil. 2009 Feb;90(2):193-200. doi: 10.1016/j.apmr.2008.07.026.

    PubMed 19236973
  • Tran K, Hukins C, Geraghty T, Eckert B, Fraser L. Sleep-disordered breathing in spinal cord-injured patients: a short-term longitudinal study. Respirology. 2010 Feb;15(2):272-6. doi: 10.1111/j.1440-1843.2009.01669.x. Epub 2009 Nov 30.

    PubMed 19947995
  • Burns SP, Rad MY, Bryant S, Kapur V. Long-term treatment of sleep apnea in persons with spinal cord injury. Am J Phys Med Rehabil. 2005 Aug;84(8):620-6. doi: 10.1097/01.phm.0000171008.69453.b9.

    PubMed 16034232
  • Raguindin PF, Frankl G, Itodo OA, Bertolo A, Zeh RM, Capossela S, Minder B, Stoyanov J, Stucki G, Franco OH, Muka T, Glisic M. The neurological level of spinal cord injury and cardiovascular risk factors: a systematic review and meta-analysis. Spinal Cord. 2021 Nov;59(11):1135-1145. doi: 10.1038/s41393-021-00678-6. Epub 2021 Aug 20.

    PubMed 34417550
  • Schuster AK, Fischer JE, Thayer JF, Mauss D, Jarczok MN. Decreased heart rate variability correlates to increased cardiovascular risk. Int J Cardiol. 2016 Jan 15;203:728-30. doi: 10.1016/j.ijcard.2015.11.027. Epub 2015 Nov 6. No abstract available.

    PubMed 26587729
  • Solinsky R, Vivodtzev I, Hamner JW, Taylor JA. The effect of heart rate variability on blood pressure is augmented in spinal cord injury and is unaltered by exercise training. Clin Auton Res. 2021 Apr;31(2):293-301. doi: 10.1007/s10286-020-00677-2. Epub 2020 Mar 12.

    PubMed 32166421
  • Ely MR, Schleifer GD, Singh TK, Baggish AL, Taylor JA. Exercise Training Does Not Attenuate Cardiac Atrophy or Loss of Function in Individuals With Acute Spinal Cord Injury: A Pilot Study. Arch Phys Med Rehabil. 2023 Jun;104(6):909-917. doi: 10.1016/j.apmr.2022.12.001. Epub 2022 Dec 23.

    PubMed 36572202
  • Solinsky R, Mercier H, Picard G, Taylor JA. Cardiometabolic Effects of High-Intensity Hybrid Functional Electrical Stimulation Exercise after Spinal Cord Injury. PM R. 2021 Sep;13(9):937-944. doi: 10.1002/pmrj.12507. Epub 2020 Dec 4.

    PubMed 33027550
  • Chou RC, Taylor JA, Solinsky R. Effects of hybrid-functional electrical stimulation (FES) rowing whole-body exercise on neurologic improvement in subacute spinal cord injury: secondary outcomes analysis of a randomized controlled trial. Spinal Cord. 2020 Aug;58(8):914-920. doi: 10.1038/s41393-020-0445-3. Epub 2020 Feb 24.

    PubMed 32094516
  • Bertisch SM, Hamner J, Taylor JA. Slow Yogic Breathing and Long-Term Cardiac Autonomic Adaptations: A Pilot Study. J Altern Complement Med. 2017 Sep;23(9):722-729. doi: 10.1089/acm.2016.0074. Epub 2017 Apr 18.

    PubMed 28418684

Questions about this trial

What is this clinical trial studying?

A study testing Ujjayi Yogic Breathing in people with Spinal Cord Injuries, run by Spaulding Rehabilitation Hospital at 1 site in United States.

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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 5 Mar 2026. 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact J. Andrew Taylor, MS, PhD (617-758-5503, jandrew_taylor@hms.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ventilatory pattern after regular Ujjayi breathing (time frame: Change in ventilatory pattern, Time Frame: Baseline, Week 6). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06514950, which also lists 25 linked publications.

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 5 Mar 2026.

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