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

Effect of Slow Breathing and Yogic-Derived Breathing on 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Spinal Cord Injuries; Slow Breathing
• Intervention / Treatment: Behavioral: Slow Breathing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Spaulding Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. BP >140/90 mmHg
2. Current use of cardioactive medications (except medication to support blood pressure)
3. Current tobacco use
4. Significant arrhythmia
5. Coronary artery disease
6. Diabetes
7. Renal Disease
8. Cancer
9. Epilepsy or other neurological diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Spinal Cord Injury Subjects; 20 medically stable male and female subjects between 18 and 60 years old, BMI between 18.5-35 kg/m2, with a history of SCI and who use a wheelchair were included. 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Variability	R-R interval on a 5 lead Electrocardiogram (EKG)	1,5 hour during Slow-breathing
beat-by-beat arterial pressure	blood pressure fluctuations via Finometer and Dinamap blood pressure cuff	1,5 hour during Slow-breathing
beat-by-beat limb blood flow	brachial blood flow via doppler	1,5 hour during Slow-breathing
peripheral capillary oxygen saturation (SpO2)	blood oxygen saturation via pulse oximetry	1,5 hour during Slow-breathing
respiratory excursions	Measuring belly and chest depth of inspiration and expiration	1,5 hour during Slow-breathing

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Anticipated): January 20, 2024
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: spinal cord injury; pranayama; resonance; yogic
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Trauma, Nervous System; Signs and Symptoms, Respiratory; Spinal Cord Diseases; Respiratory Insufficiency; Respiratory Aspiration; Wounds and Injuries; Spinal Cord Injuries; Hypoventilation
• Other Study ID Numbers: 2022P001696

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No