Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT04592718
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2020-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Four-week Breathing Interventions on Gut Symptoms, Heart Rate Variability, and Psychological Measures in Runners
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D059265', 'term': 'Visceral Pain'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D059226', 'term': 'Nociceptive Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-07', 'studyFirstSubmitDate': '2020-10-12', 'studyFirstSubmitQcDate': '2020-10-15', 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in gastrointestinal symptom occurrence', 'timeFrame': 'The intervention will last 4 weeks. Gastrointestinal symptoms will be collected for a 1-week period before the intervention and during the 4th week of the intervention.', 'description': 'Percentage of training runs that runners experience at least 1 gastrointestinal symptom (\\>2 on 0-10 scale).'}, {'measure': 'Change in anxiety levels', 'timeFrame': 'The intervention will last 4 weeks. The General Anxiety Disorder-7 will be assessed before the intervention begins, 2 weeks into the intervention, and at the end of the intervention.', 'description': 'Levels of anxiety will be assessed with the General Anxiety Disorder-7 questionnaire. Scores on the General Anxiety Disorder-7 range from 0 to 21, with higher scores indicating higher levels of anxiety.'}], 'secondaryOutcomes': [{'measure': 'Change in visceral sensitivity', 'timeFrame': 'The intervention will last 4 weeks. The Visceral Sensitivity Index will be assessed before the intervention begins, 2 weeks into the intervention, and at the end of the intervention.', 'description': 'Perceptions of visceral sensitivity will be assessed via the Visceral Sensitivity Index. Scores on the Visceral Sensitivity Index can range from 0 to 75, with higher scores indicating a higher level of visceral sensitivity.'}, {'measure': 'Change in mindfulness', 'timeFrame': 'The intervention will last 4 weeks. The Five Facet Mindfulness Questionnaire will be assessed before the intervention begins, 2 weeks into the intervention, and at the end of the intervention.', 'description': 'Perceptions of mindfulness will be assessed via the 15-item Five Facet Mindfulness Questionnaire. Scores on the Five Facet Mindfulness Questionnaire can range from 15-75, with higher scores indicating higher levels of mindfulness.'}, {'measure': 'Change in body vigilance', 'timeFrame': 'The intervention will last 4 weeks. The Body Vigilance Scale will be assessed before the intervention begins, 2 weeks into the intervention, and at the end of the intervention.', 'description': 'Perceptions of body vigilance will be assessed via the Body Vigilance Scale. Scores on the Body Vigilance Scale can range from 0-40, with higher levels meaning greater amounts of body vigilance.'}, {'measure': 'Change in heart rate variability (Ln RMSSD)', 'timeFrame': 'The intervention will last 4 weeks. Ln RMSSD will be assessed before the intervention begins, and at the end of the intervention.', 'description': 'Heart rate variability will be assessed via a portable fingertip monitor (CorSense) and quantified as the Ln root mean square of successive differences (Ln RMSSD) between normal heartbeats.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrointestinal System--Abnormalities', 'Anxiety', 'Visceral Pain']}, 'descriptionModule': {'briefSummary': 'Recent research has suggested that stress and anxiety levels are associated with gastrointestinal (GI) symptoms in endurance athletes (runners, cyclists, triathletes). Yet, there has been limited attempt to evaluate whether GI symptoms during running can be mitigated by interventions designed to reduce stress and anxiety. Thus, this study will evaluate the effects of four-week slow deep breathing and mindful breath counting interventions on subjective and objective measures of stress/anxiety and GI symptoms in runners with mild-to-high anxiety and that are prone to GI symptoms during runs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Run at least 15 miles per week\n* Access to internet\n* Access to a smart phone that is compatible with iOS or Android applications\n* Score at least a 5 on the GAD-7\n* Report to have experienced GI symptoms "sometimes", "often" or "always" during runs in the previous month.\n* If on a psychotropic medication, must be on a stable dose for the past 3 months.\n* Live within the contiguous United States\n\nExclusion Criteria:\n\n* Younger than 18 years\n* Run less than 15 miles per week\n* Do not have access to the internet\n* Do not have access to a smart phone that is compatible with iOS or Android applications\n* Score less than 5 on the GAD-7\n* Report to have "never" or "rarely" experienced GI symptoms during runs in the previous month\n* Are being prescribed a psychotropic medication and have not had a stable dose for at least three months.\n* Do not live within the contiguous United States'}, 'identificationModule': {'nctId': 'NCT04592718', 'briefTitle': 'Four-week Breathing Interventions on Gut Symptoms, Heart Rate Variability, and Psychological Measures in Runners', 'organization': {'class': 'OTHER', 'fullName': 'Old Dominion University'}, 'officialTitle': 'The Effects of Four-week Breathing Interventions on Gastrointestinal Symptoms, Heart Rate Variability, and Psychological Measures in Runners', 'orgStudyIdInfo': {'id': '1655312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Slow deep breathing plus breath counting', 'description': 'Participants in this group will do a daily 5-min slow deep breathing exercise (6 breaths/minute) and will also count their breaths', 'interventionNames': ['Behavioral: Slow deep breathing plus breath counting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal-paced breathing plus breath counting', 'description': 'Participants in this group will do a daily 5-min normal-paced breathing (15 breaths/minute) and will also count their breaths', 'interventionNames': ['Behavioral: Normal-paced breathing plus breath counting']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants in this group will serve as a control and will not do any breathing exercises or breath counting.'}], 'interventions': [{'name': 'Slow deep breathing plus breath counting', 'type': 'BEHAVIORAL', 'description': 'Participants will perform a daily 5-min slow deep breathing exercise for 4 weeks. A breathing rate of 6 breaths per minute will be targeted. In addition, participants will count their breaths during the exercise.', 'armGroupLabels': ['Slow deep breathing plus breath counting']}, {'name': 'Normal-paced breathing plus breath counting', 'type': 'BEHAVIORAL', 'description': 'Participants will perform a daily 5-min normal-paced breathing exercise for 4 weeks. A breathing rate of 15 breaths per minute will be targeted. In addition, participants will count their breaths during the exercise.', 'armGroupLabels': ['Normal-paced breathing plus breath counting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23529', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Human Performance Laboratory', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Patrick Wilson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Old Dominion University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Old Dominion University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Exercise Science', 'investigatorFullName': 'Patrick Wilson, PhD', 'investigatorAffiliation': 'Old Dominion University'}}}}