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Recruiting NCT06514950

Yoga Breath Training to Improve Cardiorespiratory Synchrony in Spinal Cord Injury

No phase Interventional Spinal Cord Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ujjayi Yogic Breathing.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Ventilatory pattern after regular Ujjayi breathing [Time frame: Change in ventilatory pattern, Time Frame: Baseline, Week 6]
  • Pulmonary function after regular Ujjayi breathing [Time frame: Change in pulmonary function, Time Frame: Baseline, Week 6]
  • Central and peripheral chemosensitivity after regular Ujjayi breathing [Time frame: Change in central and peripheral chemosensitivity, Time Frame: Baseline, Week 6]
  • Ventilatory perfusion after regular Ujjayi breathing [Time frame: Change in ventilatory perfusion, Time Frame: Baseline, Week 6]
  • Sleep quality after regular Ujjayi breathing [Time frame: Change in sleep quality, Time Frame: Baseline, Week 6]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Diabetes
  • Renal disease
  • Cancer
  • Epilepsy or other neurological diseases
  • Current use of CPAP/BIPAP
  • Has smartphone or device incompatible with the PranaTM application

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Spaulding Rehabilitation Hospital — Cambridge

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 16034232

Identifiers

NCT: NCT06514950 · 2024P001385

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗