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

Not Applicable

• Conditions: Spinal Cord Injuries; Slow Breathing
• Interventions: Behavioral: Slow Breathing

• Registration Number: NCT05480618
• Lead Sponsor: Spaulding Rehabilitation Hospital

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.

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 Timeline

• Study First Submitted: 2022-07-27
• Study First Submitted QC: 2022-07-27
• Study First Posted: 2022-07-29
• Study Start: 2022-08-22
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11
• Primary Completion: 2024-01-20
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spinal Cord Injury Subjects	Slow Breathing	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Spaulding Rehabilitation Hospital; 🇺🇸 Cambridge, Massachusetts, United States