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Clinical Trials/NCT06514950
NCT06514950
Recruiting
Not Applicable

Yoga Breath Training to Improve Cardiorespiratory Synchrony in Spinal Cord Injury

Spaulding Rehabilitation Hospital1 site in 1 country20 target enrollmentAugust 1, 2024

Overview

Phase
Not Applicable
Intervention
Ujjayi Yogic Breathing
Conditions
Spinal Cord Injuries
Sponsor
Spaulding Rehabilitation Hospital
Enrollment
20
Locations
1
Primary Endpoint
Pulmonary function after regular Ujjayi breathing
Status
Recruiting
Last Updated
last month

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
August 1, 2024
End Date
April 1, 2027
Last Updated
last month
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Spaulding Rehabilitation Hospital
Responsible Party
Principal Investigator
Principal Investigator

J. Andrew Taylor

PhD

Spaulding Rehabilitation Hospital

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

Arms & Interventions

Ujjayi yogic breathing training

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

Intervention: Ujjayi Yogic Breathing

Outcomes

Primary Outcomes

Pulmonary function after regular Ujjayi breathing

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

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).

Ventilatory perfusion after regular Ujjayi breathing

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

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.

Sleep quality after regular Ujjayi breathing

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

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.

Ventilatory pattern after regular Ujjayi breathing

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

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.

Central and peripheral chemosensitivity after regular Ujjayi breathing

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

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.

Study Sites (1)

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