Yoga Breath Training for Spinal Cord Injury

Overseen By Maria Sukhoplyasova, BSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

Must not be taking: Cardioactive medications, Tobacco

Disqualifiers: Hypertension, Pulmonary disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special yoga breathing technique, called Ujjayi, can help people with spinal cord injuries. The researchers aim to determine if this breathing practice improves lung function, breathing patterns, and sleep quality. Participants will practice the technique over six weeks and undergo tests to assess their breathing and sleep before and after. This trial may suit wheelchair users with spinal cord injuries who can follow directions and are in stable health. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance the quality of life for those with spinal cord injuries.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using tobacco or certain heart-related medications, except those for blood pressure.

What prior data suggests that Ujjayi yogic breathing is safe for individuals with spinal cord injuries?

Research shows that Ujjayi breathing, a slow yoga breathing technique, is generally safe for people with spinal cord injuries. Studies have found that it can improve lung function and increase blood oxygen levels. Participants in these studies did not report any major negative effects, indicating that Ujjayi breathing is well-tolerated.

However, because this technique involves controlled breathing, some people might experience slight discomfort or dizziness, especially if unfamiliar with it. Overall, the practice is considered safe, with the benefits likely outweighing these mild effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Ujjayi Yogic Breathing for spinal cord injury because it offers a non-invasive and accessible approach to rehabilitation. Unlike traditional treatments that often rely on medication or surgical interventions, this technique uses controlled breathing to potentially improve respiratory function and overall well-being. By engaging in Ujjayi breathing, individuals might enhance autonomic function and stress management, which are crucial areas often impacted by spinal cord injuries. This method is particularly promising because it empowers patients to actively participate in their own care through a simple, yet potentially impactful, practice.

What evidence suggests that Ujjayi yogic breathing might be an effective treatment for spinal cord injury?

Research has shown that Ujjayi breathing can improve breathing in people with spinal cord injuries. One study found that this breathing technique increased blood oxygen levels compared to normal breathing. Another study discovered that slow yogic breathing, such as Ujjayi, helps the heart and lungs work together more effectively by enhancing a system that controls blood pressure. These early findings suggest that Ujjayi breathing might enhance lung function and breathing patterns, making it a promising practice for those with spinal cord injuries. Participants in this trial will undergo Ujjayi yogic breathing training to further explore these potential benefits. ^{2 3 4 5 6}

Who Is on the Research Team?

J. Andrew Taylor, MS, PhD

Principal Investigator

Harvard Medical School/Spaulding Rehabilitation Hospital

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-60 with spinal cord injuries. It's designed to see if a type of yogic breathing called Ujjayi can improve their respiratory function and sleep quality. Participants will need to commit to six weeks of breath training and lab visits for various tests.

Inclusion Criteria

Body mass index of 18.5 - 35 kg/m2

I am medically stable and can follow instructions.

I use a wheelchair.

Exclusion Criteria

Resting blood pressure of >140/90 mmHg

Has smartphone or device incompatible with the PranaTM application

I have epilepsy or another neurological condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline laboratory assessments including measurements of blood pressure, pulse, blood oxygen levels, and breathing, as well as pulmonary function testing and other breathing exercises.

1 week

1 visit (in-person)

Treatment

Participants practice Ujjayi breathing for six weeks, with coaching sessions in weeks 1 and 4, and virtual support for home practice.

6 weeks

2 visits (in-person), virtual support for home practice

Post-intervention Assessment

Participants undergo post-intervention laboratory assessments similar to baseline, to measure changes in pulmonary function, ventilatory perfusion, ventilatory pattern, chemosensitivity, and sleep quality.

1 week

1 visit (in-person)

Follow-up

Participants are monitored for any long-term effects and safety after the intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ujjayi Yogic Breathing

Trial Overview The study is testing the effects of Ujjayi Yogic Breathing on people with spinal cord injuries, focusing on breathing patterns, lung function, ventilatory control by the nervous system, air-blood flow matching in lungs, and sleep quality. The intervention includes six weeks of breath training.

How Is the Trial Designed?

Group I: Ujjayi yogic breathing training Experimental Treatment 1 Intervention

This study will be a small (N = 20) prospective cohort study with a single unblinded intervention of Ujjayi resistance breathing.

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

Published Research Related to This Trial

Only 30% of the 40 reviewed clinical trials on acute spinal cord injury provided satisfactory reporting of adverse events, indicating a significant gap in safety information that is crucial for assessing risk and designing future studies.

A staggering 82.5% of trials failed to report laboratory-defined toxicity satisfactorily, highlighting the need for improved standards in safety reporting to ensure comprehensive understanding of treatment risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. Aspinall, P., Harrison, L., Scheuren, P., et al.[2023]

A systematic review of 94 randomized controlled trials involving 8,430 participants found that yoga is as safe as usual care and exercise, with no significant differences in serious adverse events or dropouts due to adverse events.

While yoga had a higher occurrence of nonserious adverse events compared to psychological or educational interventions, the overall safety profile suggests that it is a viable therapeutic option, highlighting the need for better reporting of safety data in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cramer, H., Ward, L., Saper, R., et al.[2018]

Spinal cord injuries often leave some neural pathways intact, which can be targeted for recovery through various non-invasive respiratory treatments, enhancing neuroplasticity and long-term recovery.

The review discusses current and emerging respiratory training strategies, such as strength training and chemical stimulation, that may not only improve respiratory function but also positively impact other networks, like locomotion, after cervical level spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory Training and Plasticity After Cervical Spinal Cord Injury. Randelman, M., Zholudeva, LV., Vinit, S., et al.[2022]

A study involving 86 yoga teachers identified best practices for adapting community-based yoga for individuals with traumatic brain injury (TBI), emphasizing the importance of creating a safe and supportive environment with props and low sensory stimulation.

Teachers found the LoveYourBrain Yoga program manual very helpful, but many adapted its content to better meet the needs of TBI participants, highlighting the need for flexibility in instruction and the importance of slow, simple, and repeated cues for effective learning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best Practices for Adapting and Delivering Community-Based Yoga for People with Traumatic Brain Injury in the United States and Canada. Chauhan, N., Zeller, S., Donnelly, KZ.[2020]

In a pilot study involving 6 participants with spinal cord injuries, an 8-week community exercise program that included inspiratory muscle training (IMT) led to significant improvements in functional measures such as transfer times and trunk strength.

Participants reported positive impacts from the program, suggesting that combining IMT with community exercise may help reduce respiratory complications and improve overall health outcomes for individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community exercise for individuals with spinal cord injury with inspiratory muscle training: A pilot study. Leathem, JM., Macht-Sliwinski, M., Boak, S., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38507692/

Cardiorespiratory Effects of Yogic Versus Slow Breathing in ... Results: As expected, all slow breathing patterns markedly increased respiratory sinus arrhythmia (RSA) compared with Unpaced in all (n = 12) ...

2. liebertpub.com liebertpub.com/doi/10.1089/jicm.2023.0641

Cardiorespiratory Effects of Yogic Versus Slow Breathing in ... More importantly, Ujjayi breathing appeared to improve ventilatory efficiency over Unpaced breathing in individuals with SCI by increasing O2 saturation (97.6% ...

3. studenttheses.uu.nl studenttheses.uu.nl/handle/20.500.12932/43994

Effect of Slow Breathing and Yogic-Derived ... These findings suggest that slow yogic breathing with respiratory resistance (ujjayi) shifts cardiovascular control to a baroreflex- mediated feedback ...

4. ctv.veeva.com ctv.veeva.com/study/yoga-breath-training-to-improve-cardiorespiratory-synchrony-in-spinal-cord-injury

Yoga Breath Training to Improve Cardiorespiratory Synchrony ... ... yogic breathing technique called Ujjayi, would benefit individuals between the ages of 18 and 60 with spinal cord injuries. Previously yogic ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0149763423004220

High ventilation breathwork practices: An overview of their ... Both yogic pranayama techniques have been practiced extremely rapidly at over 200 breaths/min (Frostell et al., 1983), in addition to gently (Dhruva et al., ...

6. researchgate.net researchgate.net/publication/379116961_Cardiorespiratory_Effects_of_Yogic_Versus_Slow_Breathing_in_Individuals_with_a_Spinal_Cord_Injury_An_Exploratory_Cohort_Study

Cardiorespiratory Effects of Yogic Versus Slow Breathing in ... More importantly, Ujjayi breathing appeared to improve ventilatory efficiency over Unpaced breathing in individuals with SCI by increasing O2 saturation (97.6% ...