Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-01-02 @ 2:42 AM
Study NCT ID:
NCT02379559
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2014-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Intervention Metabolic Syndrome Prostate Cancer Black Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-17', 'studyFirstSubmitDate': '2014-09-23', 'studyFirstSubmitQcDate': '2015-03-04', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Waist circumference', 'timeFrame': '6-months', 'description': 'Waist circumference will be measured at baseline, 3- and 6-months of the intervention'}], 'secondaryOutcomes': [{'measure': 'Dietary behaviors questionnaire', 'timeFrame': '6-months', 'description': 'Block 2005 Food Frequency Questionnaires (FFQ) at baseline, 3- and 6-months of the intervention'}, {'measure': 'Cardiovascular fitness test', 'timeFrame': '6-months', 'description': 'Bruce treadmill protocol will be used to determine VO2max at baseline, 3- and 6-months of the intervention.'}, {'measure': 'Fasting glucose levels test', 'timeFrame': '6-months', 'description': 'Fasting blood sample via finger sticks will be administered by a phlebotomist to measure fasting glucose levels at baseline, 3- and 6-months of the intervention.'}, {'measure': 'Lipid level test', 'timeFrame': '6-months', 'description': 'Fasting blood sample via finger sticks will be administered by a phlebotomist to measure lipid levels at baseline, 3- and 6-months of the intervention.'}, {'measure': 'Quality of life questionnaire (SF-36)', 'timeFrame': '6-months', 'description': 'Short Form 36 Health Survey (SF-36) will be administered at baseline, 3- and 6-months of the intervention.'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': '6-months', 'description': 'Weight (lbs) and height (inches) will be measured to calculate BMI at baseline, 3- and 6-months of the intervention.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prostate cancer', 'African-American', 'Metabolic Syndrome', 'Exercise', "Men's Health"], 'conditions': ['Physical Activity', 'Metabolic Syndrome', 'Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to examine the feasibility of an exercise intervention on metabolic syndrome (MetS) components and biomarkers related to prostate cancer in Black men with MetS who are at increased risk of prostate cancer.', 'detailedDescription': 'The specific aim for the proposed study is to examine the feasibility and impact of a 6-month two-arm randomized controlled trial (RCT) on MetS components and biomarkers related to prostate cancer in Black men with MetS. Due to the striking racial disparities of prostate cancer, this proposal will focus on the impact of an aerobic and resistance exercise intervention on MetS and biomarkers related to prostate cancer in Black men. Specifically, our proposed clinical trial compares an aerobic and resistance exercise intervention to an attention control group among Black men.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. African-American and/or Black men;\n2. between the ages of 40-70 years;\n3. waist circumference \\>40 inches (102 cm);\n4. with at least two of the following: elevated BP (≥ 130/85 mmHg);\n5. elevated fasting glucose (≥ 100 mg/dL), reduced HDL cholesterol (\\<50 mg/dL), or elevated triglycerides (≥ 150 mg/dL);\n6. sedentary defined as \\<60 minutes of recreation or work requiring modest PA/week;\n7. be able to speak and read English;\n8. able to provide meaningful consent (i.e., men with severe cognitive impairment will be excluded);\n9. have no physical limitations that prevent from exercising;\n10. and have access to a television and DVD player.\n\nExclusion Criteria:\n\n1. history of cancer except nonmelanoma skin cancer;\n2. current enrollment in another clinical trial or weight loss program;\n3. inability to commit to the intervention schedule. Prior to randomization, participants will be required to have a signed authorization and medical clearance from their personal physician or our nurse practitioner.'}, 'identificationModule': {'nctId': 'NCT02379559', 'acronym': 'STRONG', 'briefTitle': 'Exercise Intervention Metabolic Syndrome Prostate Cancer Black Men', 'organization': {'class': 'OTHER', 'fullName': 'Georgetown University'}, 'officialTitle': 'An Exercise Intervention on Metabolic Syndrome and Prostate Cancer Risk Among Black Men', 'orgStudyIdInfo': {'id': 'Georgetown_University_MC1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Group', 'description': 'Eligible participants randomized into the intervention group will receive a mix of supervised moderate-intensity aerobic and light weight-resistance exercises.', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Attention Control Group', 'description': 'Eligible participants randomized in the attention control group will be asked to maintain their current daily activities and exercise habits for 6-months.', 'interventionNames': ['Behavioral: Attention Control']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'For the first 12-weeks, participants will come to our community based research office for up to 50 min/session, 3-days/week of supervised exercise. Exercise duration will increase from 75 min/wk at week 1 to 150 min/wk by week 4. Thereafter, men will maintain 150 min/wk of moderate-intensity physical activity.', 'armGroupLabels': ['Exercise Group']}, {'name': 'Attention Control', 'type': 'BEHAVIORAL', 'description': 'We will provide weekly healthy lifestyle tips via text messages, and will include tips such as managing stressors in life and getting better sleep.', 'armGroupLabels': ['Attention Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20003', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Office of Minority Health and Health Disparities Research', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgetown University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}