Yoga Breath Training to Improve Cardiorespiratory Synchrony in Spinal Cord Injury

NCT ID: NCT06514950

Last Updated: 2025-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-04-01

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Ujjayi yogic breathing training

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

Group Type EXPERIMENTAL

Ujjayi Yogic Breathing

Intervention Type BEHAVIORAL

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

Interventions

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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).

Intervention Type BEHAVIORAL

Other Intervention Names

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resistive breathing

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spaulding Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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J. Andrew Taylor

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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J. Andrew Taylor, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School/Spaulding Rehabilitation Hospital

Locations

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Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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J. Andrew Taylor, MS, PhD

Role: CONTACT

617-758-5503

Maria Sukhoplyasova, BSc

Role: CONTACT

617-758-5506

Facility Contacts

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Glen Picard, MS

Role: primary

617-758-5511

References

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Reference Type BACKGROUND
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Other Identifiers

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2024P001385

Identifier Type: -

Identifier Source: org_study_id

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