Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT03597802
Status:
UNKNOWN
Last Update Posted:
2019-04-17
First Post:
2018-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise at Workplace for Manual Material Handling Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-12-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2018-04-29', 'studyFirstSubmitQcDate': '2018-07-20', 'lastUpdatePostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Pain Intensity at 6 months', 'timeFrame': 'At baseline and after six months', 'description': 'Likert scale (0-10 points)'}, {'measure': 'Change from electromyographic signal at 6 months', 'timeFrame': 'At baseline and after six months', 'description': 'RMS (root mean square error) signal and peak signal by Electromyographic (EMG)'}], 'secondaryOutcomes': [{'measure': 'Change from palmar grip strength at 6 months', 'timeFrame': 'At baseline and six months', 'description': 'Three measure palmar grip strength to use the mean by dynamometer'}, {'measure': 'Change from body mass index at 6 months', 'timeFrame': 'At baseline and after six months', 'description': 'The body mass index will be calculated on height divided by square weight'}, {'measure': 'Change of behavior to exercise', 'timeFrame': 'At baseline and after six months', 'description': 'Practice of exercise (practice - yes or no; number of times per week)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ergonomics', 'Workplace', 'Exercise'], 'conditions': ['Ergonomics', 'Manual Material Handling', 'Occupational Health']}, 'descriptionModule': {'briefSummary': 'This study aim to evaluate the effectiveness of exercise at workplace for manual material handling workers. This is a randomized control trial study by cluster with three parallel groups (n=200). Participants will be randomized in three groups: (1) control group - will be receive ergonomics orientation . (2) Intervention group - exercise at workplace four times per week, during 15 minutes; (3) Intervention group 2 - exercise at workplace three times per week, during 15 minutes.Outcomes: The outcome measure will be verified in three moments at baseline, in six and eleven months of the intervention. The primary outcome is pain, electromyography. Secondary outcome is palmar dynamometer, BMI, physical activity level.', 'detailedDescription': 'Objective: This study aim to evaluate the effectiveness of exercise at workplace for control and prevention nonspecific low back pain. Methods: This is a randomized control trial study by cluster with three parallel groups. The context of this study is a motorcycle parts company importer localized in several states (Piaui, Ceará e Maranhão). The company has 575 workers, being 240 manual material handling. All are men over 18 years old that perform goods shipment (each work develop one this tasks - stock, separation, conference and packaging).\n\nThe inclusion criterial are workers that perform manual material handling for at least six months and signing informed consent form. The exclusion criterial were sick leave. The workers will be included with low back pain or no low back pain (at baseline). All will be interviewed to obtain: weight, height, BMI, age, marital status, educational level, and actual function (stock, separation, conference and packaging sick leave (the last 12 months), musculoskeletal complains, medications, complementary exams, surgery and or fractures. Participants will be randomized in three groups: (1) control group - will be receive orientation about manual material handling, postural and low back care (lecture and guidance). The training will be instructions according Ergonomics standard (NR17) about transportation and load handling and exercise in workout. (2) Intervention group 1 - will receive the same instruction of the control group, and will perform exercise at workplace four times per week, during 15 minutes; (3) Intervention group 2 - will be receive the same instruction of the control group, and will perform exercise at workplace three times per week, during 15 minutes. Outcomes: The outcome measure will be verified in three moments at baseline, six and eleven months of the intervention. The primary outcome is pain, electromyography. Secondary outcome is palmar dynamometer, BMI, exercise workout.\n\nExpected Results: The manual material handling workers will be better after intervention by exercise at workplace. The effectiveness of exercise for low back pain and no low back pain groups will be contribute to change the behavior in occupational context.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'It is more common to be performed by men due to handled load', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criterial are workers that perform manual material handling for at least six months and signing informed consent form.\n\nExclusion Criteria:\n\n* The exclusion criterial were sick leave'}, 'identificationModule': {'nctId': 'NCT03597802', 'briefTitle': 'Exercise at Workplace for Manual Material Handling Workers', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Cidade de Sao Paulo'}, 'officialTitle': 'Effectiveness of Exercise at Workplace for Manual Material Handling Workers', 'orgStudyIdInfo': {'id': '2.372.435'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance).'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention group 1', 'description': 'The workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance), and will perform exercise at workplace three times per week, during 15 minutes', 'interventionNames': ['Other: Exercise at workplace - Four times per week']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention group 2', 'description': 'The workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance) and and will perform exercise at workplace four times per week, during 15 minutes.', 'interventionNames': ['Other: Exercise at workplace - Three times per week']}], 'interventions': [{'name': 'Exercise at workplace - Three times per week', 'type': 'OTHER', 'description': 'The exercise at workplace will be occur during the workday during the rest breaks. The exercises perform are stretching, and using load.', 'armGroupLabels': ['Intervention group 2']}, {'name': 'Exercise at workplace - Four times per week', 'type': 'OTHER', 'description': 'The exercise at workplace will be occur during the workday during the rest breaks. The exercises perform are stretching, and using load.', 'armGroupLabels': ['Intervention group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12942770', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Rosimeire S Padula', 'role': 'CONTACT', 'email': 'rosipadula@gmail.com', 'phone': '+55 11999166215'}], 'facility': 'Rosimeire Simprini Padula', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Cidade de Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Rosimeire Simprini Padula', 'investigatorAffiliation': 'Universidade Cidade de Sao Paulo'}}}}