Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
Study NCT ID:
NCT06604650
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2024-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Community Park-Based Programs for Health Promotion: Active Older Adults Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular 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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2024-09-10', 'studyFirstSubmitQcDate': '2024-09-17', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body mass index (height and weight)', 'timeFrame': 'Baseline, 12 months, 36 months'}, {'measure': 'Change in blood pressure', 'timeFrame': 'Baseline, 12 months, 36 months'}, {'measure': 'Change in arm strength', 'timeFrame': 'Baseline, 12 months, 36 months', 'description': 'Participant arm strength is measured as the total number of arm curls performed in 30 seconds. Participants are seated in a chair while holding a dumbbell or cuff weight (5lb for women and 8lb for men) wrapped around their right or left wrist (the left wrist is employed when the right wrist is impractical).'}, {'measure': 'Change in leg strength', 'timeFrame': 'Baseline, 12 months, 36 months', 'description': 'Leg strength is assessed as the number of chair stands a person could complete in 30 seconds. For one chair stand, participants get up from their seats (with assistance if necessary) and then sit back down.'}, {'measure': 'Change in mobility', 'timeFrame': 'Baseline, 12 months, 36 months', 'description': 'Mobility is measured as the time spent in an Eight-Foot-Up-and-Go test. Participants start seated in a chair, and are instructed to stand up, quickly circle a cone placed eight feet in front of the chair, and then sit back down in the chair. The stopwatch will start when the person fully stands up from the chair and stops when the person sits back down into the chair (recorded in seconds).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Overweight', 'Obesity', 'Cardiovascular Diseases', 'Sedentary Behavior', 'Low Physical Fitness']}, 'referencesModule': {'references': [{'pmid': '33348319', 'type': 'BACKGROUND', 'citation': "Kling HE, D'Agostino EM, Booth J, Hansen E, Hawver E, Mathew MS, Messiah SE. The Feasibility of Collecting Longitudinal Cardiovascular and Fitness Outcomes From a Neighborhood Park-Based Fitness Program in Ethnically Diverse Older Adults: A Proof-of-Concept Study. J Aging Phys Act. 2021 Jun 1;29(3):496-504. doi: 10.1123/japa.2020-0139. Epub 2020 Dec 20."}, {'pmid': '30589639', 'type': 'BACKGROUND', 'citation': "Kling HE, D'Agostino EM, Booth JV, Patel H, Hansen E, Mathew MS, Messiah SE. The Effect of a Park-Based Physical Activity Program on Cardiovascular, Strength, and Mobility Outcomes Among a Sample of Racially/Ethnically Diverse Adults Aged 55 or Older. Prev Chronic Dis. 2018 Dec 27;15:E166. doi: 10.5888/pcd15.180326."}]}, 'descriptionModule': {'briefSummary': 'The Active Older Adults prospective cohort study examines the effects of a park-based fitness program on cardiovascular fitness outcomes for older adults (aged 50 years and older). Duke will perform a secondary analysis of the data collected as part of the Active Older Adults prospective cohort study run by Miami-Dade County Parks and Recreation.', 'detailedDescription': "The Active Older Adults prospective cohort study examines the effects of a park-based fitness program on cardiovascular fitness outcomes for older adults (aged 50 years and older). Active Older Adults is designed to provide older adults of all fitness levels with physical activity, and aims to promote participant's abilities to maintain independent lifestyles. It is a low-cost, evidence-based group exercise and falls-prevention program. The program entails one-hour sessions two or three times per week including aerobic workout, strength training, balance and flexibility exercise delivered online or in-person. Data are collected at eight Miami Dade Department of Parks, Recreation and Open Spaces (MDPROS) park locations where the program is offered every four months (fall, winter, spring).\n\nActive Older Adults is a park-based fitness program offered by the Miami Dade Department of Parks, Recreation and Open Spaces (MDPROS) that is designed to provide older adults of all fitness levels with physical activity, and aims to promote participant's abilities to maintain independent lifestyles. It is a low-cost, evidence-based group exercise and falls-prevention program. The program entails one-hour sessions two or three times per week including aerobic workout, strength training, balance and flexibility exercise delivered online or in-person. Exercise classes at each park location are offered by bilingual (English/Spanish) licensed instructors and program classes had a consistent format across all parks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Active Older Adults is offered in Miami-Dade County (MDC), FL where 40.9% of people older than 65 are sedentary (did not participate in any leisure-time activities, physical activities other than their regular job, during the past month). Within MDC, age-adjusted death rates per 100,000 population (2020-2022) from cardiovascular disease were higher for both Black (291.8.7 vs. 263.4) and Hispanic (179.2 vs. 171.2) residents of MDC vs. statewide, respectively, compared with White (186.2 vs. 198.7) residents. This disparity is particularly relevant for MDC where 69% of people identify as Hispanic or Latino and 17% identify as Black, as opposed to about 19% and 14%, respectively in the United States and 27% and 17% respectively in Florida.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 50 years or older, residing in Miami-Dade County\n* All participants enrolled in the Miami-Dade Active Older Adults study will be included in this secondary analysis\n\nExclusion Criteria:\n\n* Aged less than 50 years, not residing in Miami-Dade County\n* Anyone not enrolled in the Miami-Dade Active Older Adults study will be excluded from this secondary analysis'}, 'identificationModule': {'nctId': 'NCT06604650', 'acronym': 'AOA', 'briefTitle': 'Community Park-Based Programs for Health Promotion: Active Older Adults Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Community Park-Based Programs for Health Promotion: Active Older Adults Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'Pro00105669_1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Active Older Adults', 'description': 'Body mass index (height and weight), blood pressure and pulse, arm and leg strength and mobility', 'interventionNames': ['Behavioral: Active older Adults']}], 'interventions': [{'name': 'Active older Adults', 'type': 'BEHAVIORAL', 'description': 'The program entails one-hour sessions two or three times per week including aerobic workout, strength training, balance and flexibility exercise delivered online or in-person. Miami-Dade Parks and Recreation is the sponsor of the Active Older Adults prospective cohort study. Duke is conducting a secondary data analysis on data collected as part of the Active Older Adults study.', 'armGroupLabels': ['Active Older Adults']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33128', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Miami-Dade County Parks, Recreation and Open Spaces Department', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': "Emily M D'Agostino, DPH, MS, MEd, MA", 'role': 'CONTACT', 'email': 'emily.m.dagostino@duke.edu'}], 'overallOfficials': [{'name': "Emily D'Agostino", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Miami-Dade County Parks and Recreation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}