Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT02870868
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2016-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Breathing Interventions for Relaxation: Dosing Through Extended Exhale
Sponsor:
Organization:
Raw JSON
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'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, 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'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56.2', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '56.5', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '56.444', 'spread': '4.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measure of psychological stress taken at baseline before any study intervention.\n\nThe scale ranges from 0 (no anxiety) to 100 (maximal anxiety). In the normal adult population, the average of the PROMIS Cooperative Group. (2011). Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety score is 50. A higher score correlates with increased anxiety and a lower score correlates with lower anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing data'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-15', 'size': 579204, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-14T14:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-03', 'studyFirstSubmitDate': '2016-08-12', 'resultsFirstSubmitDate': '2024-01-17', 'studyFirstSubmitQcDate': '2016-08-12', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-03', 'studyFirstPostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnitude of Change in High Frequency Heart Rate Variability', 'timeFrame': 'Baseline', 'description': 'This is a proxy measure of parasympathetic tone. In normal healthy adults, the average value is around 600 ms\\^2 (miliseconds\\*miliseconds). In hypertensive adults, the average value is around 100 ms\\^2. In patients with autonomic failure (who lacks parasympathetic tone), the average value is around 20 ms\\^2.'}, {'measure': 'Magnitude of Change in High Frequency Heart Rate Variability', 'timeFrame': '6 weeks', 'description': 'This is a proxy measure of parasympathetic tone. In normal healthy adults, the average value is around 600 ms\\^2 (miliseconds\\*miliseconds). In hypertensive adults, the average value is around 100 ms\\^2. In patients with autonomic failure (who lacks parasympathetic tone), the average value is around 20 ms\\^2.'}, {'measure': 'Magnitude of Change in High Frequency Heart Rate Variability', 'timeFrame': '12 weeks', 'description': 'This is a proxy measure of parasympathetic tone. In normal healthy adults, the average value is around 600 ms\\^2 (miliseconds\\*miliseconds). In hypertensive adults, the average value is around 100 ms\\^2. In patients with autonomic failure (who lacks parasympathetic tone), the average value is around 20 ms\\^2.'}, {'measure': 'Magnitude of Change in PROMIS Anxiety Scale', 'timeFrame': 'Baseline', 'description': 'Measure of psychological stress taken at baseline before any study intervention.\n\nThe scale ranges from 0 (no anxiety) to 100 (maximal anxiety). In the normal adult population, the average of the PROMIS Cooperative Group. (2011). Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety score is 50. A higher score correlates with increased anxiety and a lower score correlates with lower anxiety.'}, {'measure': 'Magnitude of Change in PROMIS Anxiety Scale', 'timeFrame': '6 weeks', 'description': 'Measure of psychological stress taken at baseline before any study intervention.\n\nThe scale ranges from 0 (no anxiety) to 100 (maximal anxiety). In the normal adult population, the average of the PROMIS Cooperative Group. (2011). Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety score is 50. A higher score correlates with increased anxiety and a lower score correlates with lower anxiety.'}, {'measure': 'Magnitude of Change in PROMIS Anxiety Scale', 'timeFrame': '12-weeks', 'description': 'Measure of psychological stress taken at baseline before any study intervention.\n\nThe scale ranges from 0 (no anxiety) to 100 (maximal anxiety). In the normal adult population, the average of the PROMIS Cooperative Group. (2011). Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety score is 50. A higher score correlates with increased anxiety and a lower score correlates with lower anxiety.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['slow breathing', 'yoga', 'mind-body practicers'], 'conditions': ['Healthy Adults', 'Stress']}, 'descriptionModule': {'briefSummary': 'Breathing exercises are categorized as a mind-body practice. One in ten adults in the U.S. use breathing exercises for health purposes. The aim of this project is to examine if different slow breathing has different physiological and psychological effects.', 'detailedDescription': 'Breathing exercises are categorized as a mind-body practice. One in ten adults in the U.S. use breathing exercises for health purposes. Slow breathing exercises are commonly used for stress reduction. Higher stress is associated with higher cardiovascular risk. Effective and standardized breathing interventions for stress reduction have not been developed or well-studied. For centuries, mind-body practitioners have proposed that, in addition to breathing slowly, extending the length of exhale relative to inhale increases the dose of relaxation. Few studies have tested this belief. The aim of this proposal is to examine if slow breathing while extending the exhale time relative to the inhale time increases physiological and psychological relaxation. The slow breathing exercises to be studied are based on breathing techniques from yoga. This is a12-week study among healthy adults randomized to daily slow breathing exercises of: (1) exhale greater than inhale versus (2) exhale equal to inhale in length. The first aim of the studies will be to compare 12 weeks of slow breathing with exhale greater than inhale on physiological stress as measured through autonomic tone. The second aim will be to compare changes in psychological stress as measured through validated stress and anxiety questionnaires. The final and third aim will be to measure the correlation between changes in physiological and psychological stress. This project will test if specific breathing techniques produce measurable and meaningful differences in stress in both healthy and disease populations. Because stress reduction is considered the major mechanism of mind-body practices, these studies will advance the field of mind-body science.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 30 to 60 years\n* English speaking\n\nExclusion Criteria:\n\n* Hypertension\n* Heart disease: history of coronary artery disease, myocardial infarction, significant valvular disease, or congestive heart failure\n* Diabetes\n* Renal disease\n* Anxiety disorder\n* Depression\n* Other psychiatric conditions including schizophrenia or bipolar disorder\n* Attention-deficit-disorder or Attention-deficit-hyperactivity disorder\n* Musculoskeletal condition limiting capacity to perform simple movements such as chronic lower back pain or neck pain\n* Pulmonary disorder (asthma, chronic obstructive lung disease, obstructive sleep apnea)\n* Smoker\n* Currently taking blood pressure medications, oral diabetic medication or insulin\n* Current participation in a mind-body practice/program\n* Current cancer other than non- melanoma skin cancer\n* Regular swimmer\n* Plays wind or brass musical instruments\n\nAfter two weeks during screening period unable to:\n\n* Breathe 8 or less a minute\n* Breathe 3 or less breaths a minute\n* Practiced less than 3 times a week'}, 'identificationModule': {'nctId': 'NCT02870868', 'briefTitle': 'Breathing Interventions for Relaxation: Dosing Through Extended Exhale', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Breathing Interventions for Relaxation: Dosing Through Extended Exhale', 'orgStudyIdInfo': {'id': '160817'}, 'secondaryIdInfos': [{'id': '1R61AT009340', 'link': 'https://reporter.nih.gov/quickSearch/1R61AT009340', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Slow breathing with exhale greater than inhale', 'description': 'Participants randomized to slow breathing with prolonged exhale to inhale ratio received progressive increases in expiration relative to inspiration based on initial assessment until they reached a goal breath length or longest comfortable breath. Prior to performing the breathing practice, subjects in this exhale\\>inhale condition performed the same yoga movements as the exhale-inhale group.', 'interventionNames': ['Behavioral: Slow breathing']}, {'type': 'EXPERIMENTAL', 'label': 'Slow breathing with exhale equal to inhale', 'description': 'Participants randomized to slow breathing with equal inspiration and expiration received progressive increases in both inspiration and expiration over 4 weeks until they reach a goal breath length or longest comfortable breath. Goal breaths were assigned based on initial breath assessment. Prior to performing the breathing practice, participants performed a few standardized yoga movements. The purpose of movements was to prepare the subject to sit and focus on breathing. Subjects randomized to exhale=inhale will receive progressive increases in both inspiration and expiration until they reach a goal breath length. Goal breaths will be assigned based on initial breath assessment. Prior to performing the breathing practice, subjects will perform a set of standardized breathing practices. The purpose of these few breathing practices is to prepare the subject to sit and focus on breathing.', 'interventionNames': ['Behavioral: Slow breathing']}], 'interventions': [{'name': 'Slow breathing', 'type': 'BEHAVIORAL', 'description': 'Slow breathing techniques from yoga', 'armGroupLabels': ['Slow breathing with exhale equal to inhale', 'Slow breathing with exhale greater than inhale']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Gurjeet Birdee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Professor', 'investigatorFullName': 'Alfredo Gamboa', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}