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

Sponsor

Spaulding Rehabilitation Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05480618

Collaborator

(none)

Enrollment

Arm

4.3

Anticipated Duration (Months)

Study Details

Study Description

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). We are doing the research to investigate if traditional 'yogic' breathing ex-ercises can be performed by subjects with SCI and its influence on the cardiovascular system.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries Slow Breathing	Behavioral: Slow Breathing	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This study will be a small prospective cohort (N= 20) 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 par-ticipant 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.This study will be a small prospective cohort (N= 20) 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 par-ticipant 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.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jul 22, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Spinal Cord Injury Subjects 20 subjects with a spinal cord injury under T4 recruited from the exercise for persons with disabilities program at Spaulding Rehabilitation Hospital or the general public.	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

Arm

Intervention/Treatment

Experimental: Spinal Cord Injury Subjects

20 subjects with a spinal cord injury under T4 recruited from the exercise for persons with disabilities program at Spaulding Rehabilitation Hospital or the general public.

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

Outcome Measures

Primary Outcome Measures

Heart Rate Variability [1,5 hour during Slow-breathing]
R-R interval on a 5 lead EKG
beat-by-beat arterial pressure [1,5 hour during Slow-breathing]
blood pressure fluctuations via Finometer and Dinamap blood pressure cuff
beat-by-beat limb blood flow [1,5 hour during Slow-breathing]
brachial blood flow via doppler
SpO2 [1,5 hour during Slow-breathing]
blood oxygen saturation via pulse oximetry
respiratory excursions [1,5 hour during Slow-breathing]
Measuring belly and chest depth of inspiration and expiration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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