Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-05-05 @ 6:56 AM
Study NCT ID:
NCT01958333
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2013-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscular and Metabolic Adaptations to Exercise to Benefit High-Risk Workforce
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2013-09-29', 'studyFirstSubmitQcDate': '2013-10-08', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Muscular strength', 'timeFrame': 'Baseline and 6 months after intervention'}, {'measure': 'Body composition', 'timeFrame': 'Baseline and 6 months after intervention'}, {'measure': 'Flexibility', 'timeFrame': 'Baseline and 6 months after intervention'}, {'measure': 'AHA/ACSM risk score', 'timeFrame': 'Baseline and 6 months after intervention'}, {'measure': 'PAR-Q score', 'timeFrame': 'Baseline and 6 months after intervention'}], 'primaryOutcomes': [{'measure': 'Cardiorespiratory endurance', 'timeFrame': 'Baseline and 6 months after intervention'}], 'secondaryOutcomes': [{'measure': 'Muscular endurance', 'timeFrame': 'Baseline and 6 months after intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Health-Related Physical Fitness', 'Aerobic Endurance', 'Muscular Endurance', 'Flexibility'], 'conditions': ['Sedentary Lifestyle']}, 'referencesModule': {'references': [{'pmid': '24053219', 'type': 'BACKGROUND', 'citation': 'Andres KL, Renn TA, Gray DA, Englund JM, Olsen GW, Letourneau BK. Evaluation of a cardiovascular Risk Reduction Program at a workplace medical clinic. Workplace Health Saf. 2013 Oct;61(10):459-66; quiz 467. doi: 10.1177/216507991306101006. Epub 2013 Sep 23.'}, {'pmid': '23930658', 'type': 'BACKGROUND', 'citation': 'Smith K. Evaluation of a stretching program to increase worker flexibility. Workplace Health Saf. 2013 Aug;61(8):329-32. doi: 10.1177/216507991306100802.'}, {'pmid': '23618884', 'type': 'BACKGROUND', 'citation': 'Birdee GS, Byrne DW, McGown PW, Rothman RL, Rolando LA, Holmes MC, Yarbrough MI. Relationship between physical inactivity and health characteristics among participants in an employee-wellness program. J Occup Environ Med. 2013 May;55(5):514-9. doi: 10.1097/JOM.0b013e31827f37d7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of three different exercise programs (e.g. low-intensity, medium-intensity, high-intensity) administered for six months on health-related physical fitness, biochemical variables and general health outcomes in high-risk employees, with about 2000 volunteers will participate in the randomized and repeated-measure study.', 'detailedDescription': 'Exercise programs (e.g. low-intensity, medium-intensity, high-intensity) consist of aerobic workout, strength training and flexibility exercise, with different program has different intensity, volume, frequency and duration of exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 years of age\n\nExclusion Criteria:\n\n* no diseases of musculoskeletal system'}, 'identificationModule': {'nctId': 'NCT01958333', 'briefTitle': 'Muscular and Metabolic Adaptations to Exercise to Benefit High-Risk Workforce', 'organization': {'class': 'OTHER', 'fullName': 'Center for Health Sciences, Serbia'}, 'officialTitle': 'The Effects of Medium-Term Exercise Program on Health-Related Physical Fitness and Biochemical Outcomes in High-Risk Employees', 'orgStudyIdInfo': {'id': '01-300613'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise 1', 'description': 'Low-intensity, low-volume cardiorespiratory exercise and strength training', 'interventionNames': ['Procedure: Exercise 1']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise 2', 'description': 'Medium-intensity, medium-volume cardiorespiratory exercise and strength training', 'interventionNames': ['Procedure: Exercise 2']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise 3', 'description': 'High-intensity, High-volume cardiorespiratory exercise and strength training', 'interventionNames': ['Procedure: Exercise 3']}], 'interventions': [{'name': 'Exercise 1', 'type': 'PROCEDURE', 'description': 'Low-intensity, low-volume cardiorespiratory exercise and strength training', 'armGroupLabels': ['Exercise 1']}, {'name': 'Exercise 2', 'type': 'PROCEDURE', 'description': 'Medium-intensity, Medium-volume cardiorespiratory exercise and strength training', 'armGroupLabels': ['Exercise 2']}, {'name': 'Exercise 3', 'type': 'PROCEDURE', 'description': 'High-intensity, High-volume cardiorespiratory exercise and strength training', 'armGroupLabels': ['Exercise 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'state': 'Serbia', 'country': 'Serbia', 'facility': 'Center for Health, Exercise and Sport Sciences', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}], 'overallOfficials': [{'name': 'Sergej M Ostojic, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Health, Exercise and Sport Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Health Sciences, Serbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Exercise Physiology Laboratory', 'investigatorFullName': 'Assoc. Prof. Sergej M. Ostojic, MD, PhD', 'investigatorAffiliation': 'Center for Health Sciences, Serbia'}}}}