- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05480618
Slow Yogic-Derived Breathing and Respiration and Cardiovascular Variability in Spinal Cord Injury Patients (SCOGA)
May 12, 2026 updated by: J. Andrew Taylor, Spaulding Rehabilitation Hospital
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
Completed
Conditions
Intervention / Treatment
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 (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Cambridge, Massachusetts, United States, 02138
- Spaulding Rehabilitation Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Spinal Cord Injured Participants
17 medically stable male and female subjects between 18 and 60 years old, BMI between 18.5-35 kg/m2, with a SCI and who use a wheelchair were recruited.
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.
|
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:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HRV
Time Frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14
|
Heart rate variability assessed in the frequency domain during paced or unpaced breathing via Welch's modified periodogram method.
Average power calculated by integrating the power spectral density in the low and high frequency bands.
|
7 minutes of paced or unpaced breathing at single study visit on Day 14
|
|
BPV
Time Frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14
|
Systolic blood pressure variability from a Finometer assessed in the frequency domain via Welch's modified periodogram method.
Average power calculated by integrating the power spectral density in the low and high frequency bands.
|
7 minutes of paced or unpaced breathing at single study visit on Day 14
|
|
SpO2
Time Frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14
|
Peripheral oxygen saturation during paced or unpaced breathing
|
7 minutes of paced or unpaced breathing at single study visit on Day 14
|
|
Expired Carbon Dioxide (CO2)
Time Frame: 7 minutes of paced or unpaced breathing at single study visit on Day 14
|
Expired CO2 from a nasal cannula
|
7 minutes of paced or unpaced breathing at single study visit on Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 22, 2022
Primary Completion (Actual)
January 20, 2024
Study Completion (Actual)
January 20, 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)
May 29, 2026
Last Update Submitted That Met QC Criteria
May 12, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Respiratory Tract Diseases
- Respiration Disorders
- Signs and Symptoms, Respiratory
- Trauma, Nervous System
- Spinal Cord Diseases
- Respiratory Insufficiency
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord Injuries
-
Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingInjury, Spinal Cord
-
Universidade do Vale do ParaíbaCompletedInjuries, Spinal Cord
-
Khon Kaen UniversityUnknownInjuries, Spinal Cord
-
Institut GuttmannNot yet recruitingSpinal Cord Injury | Spinal Cord Disease | Spinal Cord Injuries (SCI) | Traumatic Spinal Cord InjuriesSpain
-
InVivo TherapeuticsTerminated
-
Ekso BionicsBurke Medical Research InstituteCompletedInjuries, Spinal CordUnited States
-
ReWalk Robotics, Inc.Unknown
-
Chang Gung Memorial HospitalNot yet recruitingSpine Injury | Complete Spinal Cord Injury | Incomplete Spinal Cord Injury | Cord Injury, Spinal | Cord Infarction Spinal
-
Shepherd Center, Atlanta GACompletedInjuries, Spinal Cord
Clinical Trials on Slow Breathing
-
Oregon Health and Science UniversityNational Center for Complementary and Integrative Health (NCCIH); Oregon Clinical...CompletedPost-Traumatic Stress DisordersUnited States
-
Vanderbilt University Medical CenterNational Center for Complementary and Integrative Health (NCCIH)CompletedStress | Healthy AdultsUnited States
-
Albert Einstein Healthcare NetworkCompletedHeart FailureUnited States
-
University of MalagaAsociación de Pacientes de Fibromialgia y Síndrome de Fatiga Crónica de Málaga... and other collaboratorsEnrolling by invitationFibromyalgia | Fibromyalgia SyndromeSpain
-
Queen Mary University of LondonCompletedGastro Esophageal RefluxUnited Kingdom
-
Queen Mary University of LondonCompleted
-
Vanderbilt University Medical CenterWithdrawnCongestive Heart Failure
-
Texas State UniversityCompleted
-
Texas State UniversityTerminated
-
Penang Hospital, MalaysiaMinistry of Health, MalaysiaUnknown