20 Participants Needed

Yoga Breath Training for Spinal Cord Injury

JA
MS
Overseen ByMaria Sukhoplyasova, BSc
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Spaulding Rehabilitation Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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: * 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.

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 data supports the effectiveness of the treatment Ujjayi Yogic Breathing for spinal cord injury?

The research on yoga for spinal cord injury suggests that specialized yoga programs can help with pain and improve psychological well-being and mindfulness, which may indicate potential benefits of Ujjayi Yogic Breathing, a type of yoga breathing technique, for similar outcomes.12345

Is yoga breathing safe for people with spinal cord injuries?

A review of yoga safety found no serious adverse events compared to usual care or exercise, but more nonserious events compared to psychological or educational interventions. This suggests yoga, including breathing exercises, is generally safe, though minor issues may occur.12678

How does Ujjayi Yogic Breathing differ from other treatments for spinal cord injury?

Ujjayi Yogic Breathing is unique because it focuses on controlled breathing techniques to enhance neuroplasticity (the brain's ability to reorganize itself) and improve respiratory function, which is crucial for individuals with spinal cord injuries. Unlike other treatments that may involve medication or physical exercises, this method uses breath control to potentially improve both respiratory and non-respiratory functions.910111213

Research Team

JA

J. Andrew Taylor, MS, PhD

Principal Investigator

Harvard Medical School/Spaulding Rehabilitation Hospital

Eligibility Criteria

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

I am medically stable and can follow instructions.
Body mass index of 18.5 - 35 kg/m2
I have a spinal cord injury.
See 2 more

Exclusion Criteria

Resting blood pressure of >140/90 mmHg
I have cancer.
I have been diagnosed with coronary artery disease.
See 9 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Ujjayi yogic breathing trainingExperimental Treatment1 Intervention
This study will be a small (N = 20) prospective cohort study with a single unblinded intervention of Ujjayi resistance breathing.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials
143
Recruited
11,200+

Findings from Research

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

References

Evaluation of a specialized yoga program for persons with a spinal cord injury: a pilot randomized controlled trial. [2020]
A pilot feasibility study of massage to reduce pain in people with spinal cord injury during acute rehabilitation. [2022]
Pilot clinical trial of a clinical meditation and imagery intervention for chronic pain after spinal cord injury. [2022]
Is inspiratory muscle training effective for individuals with cervical spinal cord injury? A qualitative systematic review. [2018]
Is admission to an SCI specialized rehabilitation facility associated with better functional outcomes? Analysis of data from the Thai Spinal Cord Injury Registry. [2021]
The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]
A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. [2023]
Best Practices for Adapting and Delivering Community-Based Yoga for People with Traumatic Brain Injury in the United States and Canada. [2020]
Respiratory Training and Plasticity After Cervical Spinal Cord Injury. [2022]
Community exercise for individuals with spinal cord injury with inspiratory muscle training: A pilot study. [2022]
Concurrent respiratory resistance training and changes in respiratory muscle strength and sleep in an individual with spinal cord injury: case report. [2021]
Revisiting respiratory muscle strength and pulmonary function in spinal cord injury: The effect of body positions. [2019]
Effects of Respiratory Muscle Training on Baroreflex Sensitivity, Respiratory Function, and Serum Oxidative Stress in Acute Cervical Spinal Cord Injury. [2021]
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