Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:48 AM
Study NCT ID:
NCT07441551
Status:
COMPLETED
Last Update Posted:
2026-03-02
First Post:
2026-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ergonomic Risk and Musculoskeletal Characteristics in Industrial Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-24', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Joint Range of Motion', 'timeFrame': 'Baseline (single time point)', 'description': 'Active joint range of motion (ROM) of the cervical spine, lumbar spine, and upper and lower extremities was measured using a universal goniometer (Hawker et al., 2011).'}, {'measure': 'Muscle Strength', 'timeFrame': 'Baseline (single time point)', 'description': 'Hand grip strength was measured using a Jamar hand dynamometer, positioned according to the recommendations of the American Society of Hand Therapists (Mathiowetz et al., 1985). Isometric muscle strength of the deltoid, biceps brachii, triceps brachii, quadriceps, and hamstring muscle groups was assessed using a Lafayette handheld dynamometer (Mentiplay et al., 2015). Three maximal contraction trials were performed for each muscle group and hand grip strength, and the highest value obtained was recorded.'}, {'measure': 'Muscle Flexibility', 'timeFrame': 'Baseline (single time point)', 'description': 'Lumbar extensor, hamstring, and gastrosoleus muscle flexibility were evaluated using the sit-and-reach test. The distance between the middle fingertip and the testing surface was recorded in centimeters (Otman et al., 2003).'}], 'secondaryOutcomes': [{'measure': 'Musculoskeletal Complaints', 'timeFrame': 'Baseline (single time point)', 'description': 'Musculoskeletal symptoms were assessed using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), a validated self-report instrument that evaluates the presence, frequency, and severity of musculoskeletal discomfort across multiple body regions. The questionnaire also captures the extent to which discomfort interferes with work performance. Scores are calculated based on frequency, severity, and work interference multipliers, allowing region-specific and total discomfort scores to be derived. Higher scores indicate greater musculoskeletal burden (Hedge et al., 1999). The Turkish version has demonstrated established validity and reliability (Erdinc et al., 2011). In the statistical analyses, the total CMDQ score, reflecting overall musculoskeletal discomfort burden, was used.'}, {'measure': 'Ergonomic Risk Assessment', 'timeFrame': 'Baseline (single time point)', 'description': 'Ergonomic Risk Assessment: Ergonomic risk was evaluated using the Rapid Entire Body Assessment (REBA) method, an observational tool designed to assess whole-body postural risk associated with work tasks. REBA systematically scores trunk, neck, leg, and upper extremity positions, as well as load/force and coupling factors, generating a composite score that categorizes ergonomic risk into different action levels. Higher REBA scores indicate greater postural risk and the need for more urgent ergonomic intervention. Both static and dynamic working postures were directly observed and analyzed in the actual workplace environment. Observations were conducted by the same trained assessor to ensure consistency (Hignett \\& McAtamney, 2000\\[HÇ).'}, {'measure': 'Quality of Life Assessment', 'timeFrame': 'Baseline (single time point)', 'description': 'Health-related quality of life was measured using the Short Form-36 (SF-36), a widely used generic instrument consisting of eight subdomains: physical functioning, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health. Subscale scores range from 0 to 100, with higher scores representing better perceived health status (Ware \\& Sherbourne 1992). The Turkish version has demonstrated established validity and reliability (Koçyiğit et al., 1999).'}, {'measure': 'Anxiety Assessment', 'timeFrame': 'Baseline (single time point)', 'description': 'Anxiety levels were assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire designed to measure the severity of anxiety symptoms. Each item is rated on a 4-point Likert scale (0-3), yielding a total score ranging from 0 to 63. Higher scores reflect greater anxiety severity (Beck et al., 1988). The Turkish version has demonstrated established validity and reliability (Ulusoy et al., 1998). The instrument has been widely used in both clinical and occupational populations.'}, {'measure': 'Body Awareness Assessment', 'timeFrame': 'Baseline (single time point)', 'description': "Body awareness was evaluated using the Body Awareness Questionnaire (BAQ), which measures an individual's sensitivity to normal bodily processes and internal physiological signals. The scale includes items rated on a Likert-type format, with higher total scores indicating greater body awareness (Shields et al., 1989). The Turkish version has demonstrated established validity and reliability (Karaca et al., 2021). This construct is particularly relevant in occupational settings, as heightened body awareness may influence early recognition of musculoskeletal strain and adaptive behavior"}, {'measure': 'Evaluation of Satisfaction and Awareness', 'timeFrame': '8 weeks after baseline assessment', 'description': "A structured questionnaire was developed to assess participants' satisfaction with the educational components and perceived awareness. Participants rated their satisfaction with posture education, ergonomic training, exercise instruction, and information regarding musculoskeletal conditions on a 0-5 scale.\n\nBaseline knowledge regarding ergonomics, work posture, workstation organization, and preventive exercises was assessed prior to education. The same items were re-administered after eight weeks to evaluate perceived changes in awareness. The questionnaire included items related to recognition of potential musculoskeletal risks, ability to identify appropriate working postures, knowledge of ergonomic adjustments, and understanding of preventive exercises.\n\nThis evaluation aimed to describe perceived satisfaction and awareness changes rather than to determine objective clinical effectiveness."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Occupational health', 'Ergonomic risk', 'Musculoskeletal characteristics', 'Industrial workers'], 'conditions': ['Ergonomic Risk and Work-related Musculoskeletal Characteristics in Blue- and White-collar Workers']}, 'descriptionModule': {'briefSummary': 'Musculoskeletal disorders (MSDs) are among the most common occupational health problems and are closely associated with ergonomic risk factors in the workplace. Different occupational roles expose workers to distinct biomechanical and postural demands, which may influence musculoskeletal health in different ways. Field-based (blue-collar) work is typically characterized by physical workload and repetitive movements, whereas office-based (white-collar) work mainly involves prolonged sitting and static postures.\n\nThis cross-sectional comparative study aims to evaluate and compare musculoskeletal characteristics and ergonomic risk levels between blue-collar and white-collar workers employed in the same industrial setting. Full-time employees aged 18-65 years who have been working in the same factory for at least two years are included.\n\nOutcomes include muscle strength, joint range of motion, ergonomic risk assessed using the Rapid Entire Body Assessment (REBA), musculoskeletal complaints, body awareness, health-related quality of life, and anxiety levels. Objective measurements and validated self-report questionnaires are used.\n\nFollowing baseline assessment, individualized ergonomic and exercise-based recommendations are provided as part of a workplace health promotion approach. Participant satisfaction and perceived ergonomic awareness are descriptively evaluated after eight weeks. The findings aim to support occupation-specific ergonomic risk assessment and preventive strategies in industrial work environments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study Population Description\n\nThe study population consists of full-time blue-collar and white-collar employees aged 18 to 65 years who are working in the same industrial (factory) setting. Participants have been employed in the factory for at least two consecutive years and have maintained their current job position for a minimum of one year. The population represents actively working adults exposed to different occupational ergonomic demands within the same organizational environment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18 and 65 years\n* Employed in the same factory for at least two consecutive years\n* Actively working in either field-based (blue-collar) or office-based (white-collar) positions\n* Full-time employment status\n* Maintained the current job position for at least one year prior to assessment\n* Willingness to participate and provision of written informed consent\n\nExclusion Criteria\n\n* Presence of a diagnosed cardiovascular condition contraindicating physical activity\n* Orthopedic surgery within the previous 12 months\n* Presence of a neurological disorder affecting motor performance\n* Acute musculoskeletal injury within the previous 3 months\n* Currently receiving structured physiotherapy or rehabilitation for musculoskeletal conditions\n* Pregnancy at the time of assessment'}, 'identificationModule': {'nctId': 'NCT07441551', 'briefTitle': 'Ergonomic Risk and Musculoskeletal Characteristics in Industrial Workers', 'organization': {'class': 'OTHER', 'fullName': 'Istinye University'}, 'officialTitle': 'A Cross-Sectional Comparative Study Of Ergonomic Risk And Musculoskeletal Characteristics İn Blue- And White-Collar Workers İn An Industrial Setting', 'orgStudyIdInfo': {'id': 'Protocol No: 25-85'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Industrial Blue-Collar Workers', 'description': 'This cohort includes full-time field-based employees working in physically demanding tasks within an industrial (factory) setting. Participants are primarily involved in manual labor, equipment handling, repetitive movements, and activities requiring dynamic postures. No experimental intervention is applied. Following baseline assessment, participants receive individualized ergonomic and exercise-based recommendations as part of a workplace health promotion initiative.', 'interventionNames': ['Other: Workplace Ergonomic and Exercise Education']}, {'label': 'Industrial White-Collar Workers', 'description': 'This cohort includes full-time office-based employees working in administrative and desk-based roles within the same industrial setting. Participants are primarily exposed to prolonged sitting, static working postures, and computer-based tasks. No experimental intervention is applied. Following baseline assessment, participants receive individualized ergonomic and exercise-based recommendations as part of a workplace health promotion initiative.', 'interventionNames': ['Other: Workplace Ergonomic and Exercise Education']}], 'interventions': [{'name': 'Workplace Ergonomic and Exercise Education', 'type': 'OTHER', 'description': 'This intervention consists of individualized ergonomic and exercise-based recommendations provided following assessment. The content includes education on optimal working postures, workstation and task-related ergonomic principles, avoidance of prolonged static positions, safe manual handling techniques, and brief workplace-appropriate exercises aimed at promoting musculoskeletal health. The recommendations are delivered as part of a workplace health promotion and awareness approach and are not designed as a therapeutic or experimental intervention. No objective outcome-based effectiveness analysis is conducted.', 'armGroupLabels': ['Industrial Blue-Collar Workers', 'Industrial White-Collar Workers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'İstinye Üniversitesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Elif Cantürk, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'Istinye University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istinye University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}