Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT05480618
Status:
UNKNOWN
Last Update Posted:
2023-04-11
First Post:
2022-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Slow Yogic-Derived Breathing and Respiration and Cardiovascular Variability in Spinal Cord Injury Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D007040', 'term': 'Hypoventilation'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2022-07-27', 'studyFirstSubmitQcDate': '2022-07-27', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart Rate Variability', 'timeFrame': '1,5 hour during Slow-breathing', 'description': 'R-R interval on a 5 lead Electrocardiogram (EKG)'}, {'measure': 'beat-by-beat arterial pressure', 'timeFrame': '1,5 hour during Slow-breathing', 'description': 'blood pressure fluctuations via Finometer and Dinamap blood pressure cuff'}, {'measure': 'beat-by-beat limb blood flow', 'timeFrame': '1,5 hour during Slow-breathing', 'description': 'brachial blood flow via doppler'}, {'measure': 'peripheral capillary oxygen saturation (SpO2)', 'timeFrame': '1,5 hour during Slow-breathing', 'description': 'blood oxygen saturation via pulse oximetry'}, {'measure': 'respiratory excursions', 'timeFrame': '1,5 hour during Slow-breathing', 'description': 'Measuring belly and chest depth of inspiration and expiration'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['resonance', 'yogic', 'pranayama', 'spinal cord injury'], 'conditions': ['Spinal Cord Injuries', 'Slow Breathing']}, 'referencesModule': {'references': [{'pmid': '38507692', 'type': 'DERIVED', 'citation': 'Mazur MD, Hamner JW, Anand AN, Taylor JA. Cardiorespiratory Effects of Yogic Versus Slow Breathing in Individuals with a Spinal Cord Injury: An Exploratory Cohort Study. J Integr Complement Med. 2024 Sep;30(9):878-885. doi: 10.1089/jicm.2023.0641. Epub 2024 Mar 20.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18-60 years old\n2. Wheelchair user\n3. Medically stable \\& able to follow directions\n4. Body mass index (18.5 - 35 kg/m2)\n\nExclusion Criteria:\n\n1. BP \\>140/90 mmHg\n2. Current use of cardioactive medications (except medication to support blood pressure)\n3. Current tobacco use\n4. Significant arrhythmia\n5. Coronary artery disease\n6. Diabetes\n7. Renal Disease\n8. Cancer\n9. Epilepsy or other neurological diseases'}, 'identificationModule': {'nctId': 'NCT05480618', 'acronym': 'SCOGA', 'briefTitle': 'Slow Yogic-Derived Breathing and Respiration and Cardiovascular Variability in Spinal Cord Injury Patients', 'organization': {'class': 'OTHER', 'fullName': 'Spaulding Rehabilitation Hospital'}, 'officialTitle': 'Effect of Slow Breathing and Yogic-Derived Breathing on Respiration and Cardiovascular Variability in Spinal Cord Injury Patients', 'orgStudyIdInfo': {'id': '2022P001696'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spinal Cord Injury Subjects', '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.', 'interventionNames': ['Behavioral: Slow Breathing']}], 'interventions': [{'name': 'Slow Breathing', 'type': 'BEHAVIORAL', 'otherNames': ['Yogic-Derived Breathing'], '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.\n\nThe breathing techniques will be varied in:\n\n1. frequency (between 0.25 and 0.1 Hz)\n2. Inspiratory:Expiratory (I:E) ratio or 'Duty Cycle'\n3. with and without ujjayi (yogic throat restriction)\n4. with and without inspiratory/expiratory breath holding\n\nAt 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.", 'armGroupLabels': ['Spinal Cord Injury Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02138', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Spaulding Rehabilitation Hospital', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spaulding Rehabilitation Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Physical Medicine and Rehabilitation, Principal Investigator', 'investigatorFullName': 'J. Andrew Taylor', 'investigatorAffiliation': 'Spaulding Rehabilitation Hospital'}}}}