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

Spinal Cord Injuries Clinical Trial

— SCOGA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05480618
• Other study ID #: 2022P001696
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 22, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: April 2023
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: January 31, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoventilation
• Respiratory Aspiration
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

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