Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2025-12-25 @ 11:59 PM
Study NCT ID:
NCT06035094
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2023-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Exercise Intervention to Improve Overall Brain Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-06', 'studyFirstSubmitDate': '2023-09-06', 'studyFirstSubmitQcDate': '2023-09-06', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved overall Brain Care Score metric.', 'timeFrame': '10 weeks', 'description': 'The score is based on lifestyle categories on a scale of 0-21 where 21 is best.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain health', 'brain care score', 'exercise', 'hypertension', 'overweight', 'obesity', 'BMI'], 'conditions': ['Brain Care Score', 'Exercise', 'Hypertension', 'BMI']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test the effects of 10 weeks of exercise on overall brain health, reduction in blood pressure, and the number of blood vessels in the back of the eyes in patients with hypertension and have a body mass index ≥ 25 kg/m2. The main question\\[s\\] it aims to answer are:\n\n* To test the effect of moderate vs intensive exercise on Brain Care Score outcomes.\n* To ascertain the differential impact of moderate vs high intensity exercise in reducing hypertension and its downstream effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with hypertension\n* have a body mass index ≥ 25 kg/m2\n* are between the ages of 35-65 years old\n* access to a smart phone that allows installation of 2 two applications that record your workouts\n* pass a fitness evaluation.\n\nExclusion Criteria:\n\n* do not have hypertension\n* weight over 300 lbs\n* unable to pass the fitness evaluation\n* BMI less than 25kg/m2'}, 'identificationModule': {'nctId': 'NCT06035094', 'briefTitle': 'An Exercise Intervention to Improve Overall Brain Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'An Exercise Intervention to Improve Overall Brain Health: PEDAL (Physical Education for an Active Lifestyle) Study', 'orgStudyIdInfo': {'id': 'IRB-300011511'}, 'secondaryIdInfos': [{'id': '2027708', 'type': 'OTHER_GRANT', 'domain': 'McCance/ UAB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Intensity Interval Training (HIIT) exercise group,', 'description': 'Participants will be asked to exercise independently 4 days/week for 10 weeks, following a high intensity interval training (HIIT) protocol.', 'interventionNames': ['Behavioral: Exercise Intervention to improve overall Brain Health']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Intensity Training (MIT) exercise group', 'description': 'Participants will be asked to exercise independently 4 days/week for 10 weeks, following a moderate intensity training (MIT) protocol.', 'interventionNames': ['Behavioral: Exercise Intervention to improve overall Brain Health']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control exercise group', 'description': 'Participants will be advised to follow the American Heart Association (AHA) guidelines on exercise.', 'interventionNames': ['Behavioral: Exercise Intervention to improve overall Brain Health']}], 'interventions': [{'name': 'Exercise Intervention to improve overall Brain Health', 'type': 'BEHAVIORAL', 'description': 'During each exercise session, the participant will be assigned to the HIIT or MIT exercise group and asked to ride the stationary bicycle for approximately 30-40 minutes, while wearing the heart rate monitor and recording the session on their smart phone application. For each exercise session, the Polar Beat application will record the time in each of four intensity "zones". The participant will receive training on how to use the outlined schedule during the initial supervised training session.', 'armGroupLabels': ['Control exercise group', 'High Intensity Interval Training (HIIT) exercise group,', 'Moderate Intensity Training (MIT) exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Pamela G. Bowen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Pamela G Bowen PhD, CRNP, FNP-BC, BBA', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}