Slow Yogic-Derived Breathing and Respiration and Cardiovascular Variability in Spinal Cord Injury Patients

NCT05480618 | Completed Results DMC

• 1 other identifier: 2022P001696
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This research will aid in understanding of slow-breathing and its effect on heart rate and blood pressure in people with a spinal cord injury (SCI). This research will investigate if traditional 'yogic' breathing exercises can be performed by subjects with SCI and its influence on the cardiovascular system.

Conditions

Spinal Cord Injuries; Slow Breathing

Keywords

resonance; yogic; pranayama; spinal cord injury

Outcome Measures

Primary Outcomes (4)

• HRV

  Heart rate variability assessed in the frequency domain during paced or unpaced breathing via Welch's modified periodogram method. Average power calculated by integrating the power spectral density in the low and high frequency bands.

  7 minutes of paced or unpaced breathing

• BPV

  Systolic blood pressure variability from a Finometer assessed in the frequency domain via Welch's modified periodogram method. Average power calculated by integrating the power spectral density in the low and high frequency bands.

  7 minutes of paced or unpaced breathing

• SpO2

  Peripheral oxygen saturation during paced or unpaced breathing

  7 minutes of paced or unpaced breathing

• Expired Carbon Dioxide (CO2)

  Expired CO2 from a nasal cannula

  7 minutes of paced or unpaced breathing

Study Arms (1)

Spinal Cord Injured Participants

EXPERIMENTAL

17 medically stable male and female subjects between 18 and 60 years old, BMI between 18.5-35 kg/m2, with a SCI and who use a wheelchair were recruited. Participants that did not speak English or with a history of renal, neurological, or coronary artery disease, cancer, diabetes, significant arrhythmia smoking, or using cardioactive medications were excluded.

Behavioral: Slow Breathing

Interventions

Slow Breathing BEHAVIORAL

On two separate visits (on Day 1 and between Day 7 and 9 of their self-practice) the subject will be coached on yoga breathing techniques. The breathing techniques will be varied in: 1. frequency (between 0.25 and 0.1 Hz) 2. Inspiratory:Expiratory (I:E) ratio or 'Duty Cycle' 3. with and without ujjayi (yogic throat restriction) 4. with and without inspiratory/expiratory breath holding At the end of the first coaching visit the subject will be given a diary to record their own practice of the breathing techniques they were coached on.

Also known as: Yogic-Derived Breathing

Spinal Cord Injured Participants

Eligibility Criteria

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

You may qualify if:

• Age: 18-60 years old
• Wheelchair user
• Medically stable \& able to follow directions
• Body mass index (18.5 - 35 kg/m2)

You may not qualify if:

• BP \>140/90 mmHg
• Current use of cardioactive medications (except medication to support blood pressure)
• Current tobacco use
• Significant arrhythmia
• Coronary artery disease
• Diabetes
• Renal Disease
• Cancer
• Epilepsy or other neurological diseases

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (1)

• Mazur MD, Hamner JW, Anand AN, Taylor JA. Cardiorespiratory Effects of Yogic Versus Slow Breathing in Individuals with a Spinal Cord Injury: An Exploratory Cohort Study. J Integr Complement Med. 2024 Sep;30(9):878-885. doi: 10.1089/jicm.2023.0641. Epub 2024 Mar 20.

  PMID: 38507692 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Hypoventilation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This exploratory study had a limited sample size, consisting of only 12 participants and specific exclusion criteria, certain medical histories, smoking, and use of cardioactive medications potentially which may restrict the generalizability of the results. The recruitment strategy from a single rehabilitation hospital program may introduce selection bias, limiting the diversity of the sample and potentially impacting the external validity of the findings.

Results Point of Contact

• Title: J. Andrew Taylor
• Organization: Spaulding Hospital Cambridge

jandrew_taylor@hms.harvard.edu

617-753-5503

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Associate Professor of Physical Medicine and Rehabilitation, Principal Investigator

Model Details: This study was a small prospective cohort (N = 12 out of 17 completed) study with a one-time unblinded intervention of 4 differing breathing techniques/ratios compared to spontaneous breathing. Patients will receive instruction on D1 and on D7 lasting about 45 minutes and a diary for self-practice. On D14 the participant will be asked to sequentially perform the directed breathing frequencies and ratios. The lab visit will last approximately 1.5 hours, during which beat-by-beat cardiovascular variables and breath-by-breath respiratory variables will be recorded. The total in-person time commitment (\~4 hours) over the 14 days.

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 29, 2022
• Study Start: August 22, 2022
• Primary Completion: January 20, 2024
• Study Completion: January 20, 2024
• Last Updated: April 28, 2026
• Results First Posted: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)