Yoga Breath Training to Improve Cardiorespiratory Synchrony in Spinal Cord Injury

NCT06514950 | Recruiting

• 1 other identifier: 2024P001385
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

SCI, Ujjayi, yogic breathing, pranayama

Outcome Measures

Primary Outcomes (5)

• 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.

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

• 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).

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

• 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.

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

• 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.

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

• 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.

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

Study Arms (1)

Ujjayi yogic breathing training

EXPERIMENTAL

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

Behavioral: Ujjayi Yogic Breathing

Interventions

Ujjayi Yogic Breathing BEHAVIORAL

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

Also known as: resistive breathing

Ujjayi yogic breathing training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, 02138, United States

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• J. Andrew Taylor, MS, PhD

  Harvard Medical School/Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

J. Andrew Taylor, MS, PhD

CONTACT

617-758-5503; jandrew_taylor@hms.harvard.edu

Maria Sukhoplyasova, BSc

CONTACT

617-758-5506; msukhoplyasova@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)