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Completed

NCT Number: NCT05480618

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, 02138, United States

About this study

The relationship between respiratory patterns and cardiovascular variability in healthy persons has been previously studied. However, the impact of SCI on the interrelationships between the respiratory and cardiovascular systems remains relatively unstudied. The loss of autonomic control in SCI may mean that slow breathing has profound effects on cardiovascular variability. Hence, those with SCI may represent a population that could benefit from the potential physiologic effects of numerous yogic-based breathing patterns that can be applied anywhere any time. Hence, it is important to determine if slower breathing patterns can shift the cardiovascular control pattern to-wards important healthful effects. This physiological study will compare the effects of uncontrolled breathing and traditional yogic slow-breathing practices on cardiovascular variability in SCI patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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:

  • frequency (between 0.25 and 0.1 Hz)
  • Inspiratory:Expiratory (I:E) ratio or 'Duty Cycle'
  • with and without ujjayi (yogic throat restriction)
  • 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.

Other names: Yogic-Derived Breathing

Primary outcomes

  1. HRV

    Time frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14

    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.

  2. BPV

    Time frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14

    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.

  3. SpO2

    Time frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14

    Peripheral oxygen saturation during paced or unpaced breathing

  4. Expired Carbon Dioxide (CO2)

    Time frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14

    Expired CO2 from a nasal cannula

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Registry information

Official study title

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

Acronym: SCOGA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 29, 2022
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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