Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-26 @ 12:49 AM
Study NCT ID:
NCT07269834
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Workplace Exercise and Well-Being in Radiologic Technologists
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-11-25', 'studyFirstSubmitQcDate': '2025-11-25', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Quality of Life Levels', 'timeFrame': 'From baseline to 6 weeks (end of the exercise program)', 'description': 'The World Health Organization Quality of Life - BREF (WHOQOL-BREF) was used. The Portuguese version was adapted and validated by Canavarro et al. (2007).'}, {'measure': 'Changes in Burnout Levels', 'timeFrame': 'From baseline to 6 weeks (end of the exercise program)', 'description': 'The Copenhagen Burnout Inventory (CBI), developed by Kristensen et al. (2005) and adapted for the Portuguese population by Fonte (2011), was used to assess burnout levels.'}, {'measure': 'Changes in Perceived Stress Levels', 'timeFrame': 'From baseline to 6 weeks (end of the exercise program)', 'description': "The Perceived Stress Scale (PSS) was developed by Cohen, Kamarck, and Mermelstein (1983) and aims to measure an individual's subjective perception of stress intensity in their life - specifically, the degree to which situations are evaluated as unpredictable, uncontrollable, or overwhelming. The Portuguese version of the PSS-10 was validated by Trigo et al. (2010)."}], 'secondaryOutcomes': [{'measure': 'Changes in quality of life, stress, and burnout', 'timeFrame': 'End of intervention (week 6) and after 4 weeks of detraining (week 10)', 'description': 'WHOQOL-BREF; Perceived Stress Scale; Copenhagen Burnout Inventory (CBI)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Occupational Stress or Workplace Stress', 'Burnout', 'Quality of Life', 'Exercise Training', 'Radiologists', 'Health Promotion']}, 'descriptionModule': {'briefSummary': 'Radiologic technologists often face demanding work conditions that contribute to elevated stress levels and increased burnout risk, ultimately affecting both their well-being and professional effectiveness. Workplace exercise initiatives have shown potential benefits for improving physical and psychological health; however, experimental research targeting this specific occupational group is still scarce. The main aim of this study is to evaluate the effects of a structured workplace exercise intervention on perceived stress, burnout, and quality of life among radiologic technologists. The secondary objective is to assess the effects of a detraining period on the same outcomes following completion of the exercise program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy radiographers (diagnostic and therapeutic imaging technologists)\n* Currently employed in the radiology department of the participating hospital\n* Voluntary participation with signed informed consent\n\nExclusion Criteria:\n\n* Presence of major musculoskeletal, cardiovascular, or neurological conditions that contraindicate physical exercise;\n* Pregnancy;\n* Unavailability to attend regular exercise sessions'}, 'identificationModule': {'nctId': 'NCT07269834', 'briefTitle': 'Workplace Exercise and Well-Being in Radiologic Technologists', 'organization': {'class': 'OTHER', 'fullName': 'University of Beira Interior'}, 'officialTitle': 'Effects of a Workplace Exercise Program on Stress, Burnout, and Quality of Life in Radiologic Technologists', 'orgStudyIdInfo': {'id': 'EXER-RAD-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'description': 'Participants are involved in a workplace exercise program.', 'interventionNames': ['Behavioral: Workplace Exercise Program']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Non-exercise group', 'interventionNames': ['Other: Control (Non-exercise)']}], 'interventions': [{'name': 'Workplace Exercise Program', 'type': 'BEHAVIORAL', 'description': 'Participants complete a six-week workplace exercise program comprising structured sessions based on methodologies described in previous studies (Alqhtani et al., 2023; Gelfman et al., 2024). Sessions are conducted three times per week, twice per day, with each session lasting approximately 15 to 20 minutes.\n\nThe program includes exercises primarily performed in a standing position and aims to improve flexibility, balance, and strength.\n\nFlexibility training: Static and dynamic stretching exercises performed three times per week, 1-2 sets per exercise, held for 10-15 seconds each.\n\nBalance training: Static and dynamic balance exercises performed three times per week, 1-3 sets per exercise, for 10-20 repetitions or 10-20 seconds over a 3-6 meter distance.\n\nStrength training: Bodyweight and resistance exercises using auxiliary equipment (e.g., elastic bands), performed three times per week, 1-3 sets per exercise, 8-15 repetitions per set, with a slow to moderate tempo.', 'armGroupLabels': ['Exercise group']}, {'name': 'Control (Non-exercise)', 'type': 'OTHER', 'description': 'Participants in the control (non-exercise) group maintain their usual work routines and will not participate in any structured exercise sessions during the study period.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Castelo Branco', 'state': 'Castelo Branco District', 'country': 'Portugal', 'facility': 'Local Health Unit of Castelo Branco (ULSCB)', 'geoPoint': {'lat': 39.82364, 'lon': -7.49101}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'De-identified data that support the findings of this study may be made available from the corresponding author upon reasonable request and following approval by the Ethics Committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pedro Ramalho', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Beira Interior', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MSc Student', 'investigatorFullName': 'Pedro Ramalho', 'investigatorAffiliation': 'University of Beira Interior'}}}}