search
Back to results

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

Primary Purpose

Spinal Cord Injuries, Slow Breathing

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Slow Breathing
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries focused on measuring resonance, yogic, pranayama, spinal cord injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spaulding Rehabilitation Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spinal Cord Injury Subjects

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 27, 2022
Last Updated
April 10, 2023
Sponsor
Spaulding Rehabilitation Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05480618
Brief Title
Slow Yogic-Derived Breathing and Respiration and Cardiovascular Variability in Spinal Cord Injury Patients
Acronym
SCOGA
Official Title
Effect of Slow Breathing and Yogic-Derived Breathing on Respiration and Cardiovascular Variability in Spinal Cord Injury Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
January 20, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Slow Breathing
Keywords
resonance, yogic, pranayama, spinal cord injury

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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 participant 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)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal Cord Injury Subjects
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Slow Breathing
Other Intervention Name(s)
Yogic-Derived Breathing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heart Rate Variability
Description
R-R interval on a 5 lead Electrocardiogram (EKG)
Time Frame
1,5 hour during Slow-breathing
Title
beat-by-beat arterial pressure
Description
blood pressure fluctuations via Finometer and Dinamap blood pressure cuff
Time Frame
1,5 hour during Slow-breathing
Title
beat-by-beat limb blood flow
Description
brachial blood flow via doppler
Time Frame
1,5 hour during Slow-breathing
Title
peripheral capillary oxygen saturation (SpO2)
Description
blood oxygen saturation via pulse oximetry
Time Frame
1,5 hour during Slow-breathing
Title
respiratory excursions
Description
Measuring belly and chest depth of inspiration and expiration
Time Frame
1,5 hour during Slow-breathing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs