Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2026-02-13 @ 2:31 PM
Study NCT ID:
NCT04851795
Status:
UNKNOWN
Last Update Posted:
2022-07-18
First Post:
2021-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Supervised Hospital-based Physical Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-14', 'studyFirstSubmitDate': '2021-04-15', 'studyFirstSubmitQcDate': '2021-04-19', 'lastUpdatePostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Stress', 'timeFrame': 'at six months', 'description': 'Perceived stress scale-PSS. PSS scores are obtained by inverting the responses (e.g. 0 = 4, 1 = 3, 2 = 2, 3 = 1 and 4 = 0) to the four positive items (items 4, 5, 7 and 8) and then adding up all the points on the scale.'}], 'secondaryOutcomes': [{'measure': 'Goldberg anxiety questionnaire', 'timeFrame': 'at six months', 'description': 'Goldberg anxiety questionnaire. This questionnaire has a total of 9 items. A score greater than or equal to 4 is indicative of anxiety.'}, {'measure': 'Short Form Survey_Mental health', 'timeFrame': 'at six months', 'description': 'Mental component of the SF12 questionnaire. For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (worst health status for that dimension) to 100 (best health status). The number of response options ranges from three to six, depending on the item.'}, {'measure': 'Short Form Survey_Physical condition', 'timeFrame': 'at six months', 'description': 'Physical component of the SF12 questionnaire. For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (worst health status for that dimension) to 100 (best health status). The number of response options ranges from three to six, depending on the item.'}, {'measure': 'Ruffier index', 'timeFrame': 'at six months', 'description': 'The Ruffier test is a test performed to measure short-term aerobic endurance and cardiac recovery capacity, and therefore the level of physical fitness in individuals. An index below 0 indicates a good physical condition. Its average value is between 5 and 10. Above 10 the patient is considered to have a poor adaptation to exertion.'}, {'measure': 'Weight', 'timeFrame': 'at six months', 'description': 'Weight'}, {'measure': 'Body mass index', 'timeFrame': 'at six months', 'description': 'Body mass index'}, {'measure': 'lipid profile', 'timeFrame': 'at six months', 'description': 'Colesterol, HDL, LDL, triglycerides'}, {'measure': 'glycosylated hemoglobin', 'timeFrame': 'at six months', 'description': 'glycosylated hemoglobin'}, {'measure': 'work absenteeism', 'timeFrame': 'at six months', 'description': 'work absenteeism'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress, Psychological', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'To assess if physical activity is effective in reducing stress and anxiety in healthcare professionals.', 'detailedDescription': 'To assess if physical activity is effective in reducing stress and anxiety in healthcare professionals.\n\nTo evaluate if physical activity is effective in improving the physical and mental state of health care professionals and improving several blood parameters (lipid profile and blood glucose).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Apt for sports practice after review by the corresponding health professional of the Occupational Health Service,\n* Motivation for sports practice (could be self-referred or on an EVA scale from a score for example of 6) being 0 not motivated at all and 10 totally motivated.\n\nOne could extrapolate the score limits of the EVA scale pain no motivation=0; mild motivation=1,2; moderate=3-5; high from 6.\n\n* Professionals whose working day does not coincide with the hours during which the sessions are to be given.\n* Professionals who do not work shifts.\n\nExclusion Criteria:\n\n* Any type of contraindication for sports practice (Annex I),\n* Staff who, due to their activity, have greater mobility in the hospital (orderlies).\n* Osteoarticular injuries, cervical and lumbalgias.\n\nWithdrawal criteria\n\n-Within the intervention group - absence maximum two weeks to the exercises. This will not be taken into account during the summer period.'}, 'identificationModule': {'nctId': 'NCT04851795', 'briefTitle': 'Effectiveness of a Supervised Hospital-based Physical Exercise', 'organization': {'class': 'NETWORK', 'fullName': 'Bioaraba Health Research Institute'}, 'officialTitle': 'Effectiveness of a Supervised Hospital-based Physical Exercise Intervention to Reduce Stress in Health Care Professionals', 'orgStudyIdInfo': {'id': 'PA01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'supervised physical exercise sessions', 'description': 'Participants assigned to the supervised exercise group will perform a supervised routine of approximately 30 minutes, 2 days per week (Monday and Wednesday at the Txagorritxu hospital, and Tuesday and Thursday at the Santiago hospital from 7:15 to 7:45 and from 15:15 to 15:45).', 'interventionNames': ['Other: supervised physical exercise sessions']}, {'type': 'OTHER', 'label': 'unsupervised physical exercise sessions', 'description': 'For the non-supervised group, we will propose climbing the stairs from floor 0 to floor 7 three times during the working day and doing planks and stretching exercises outside of work. For the latter, an educational session will be given at the beginning of the study to explain how to perform them correctly.', 'interventionNames': ['Other: unsupervised physical exercise']}], 'interventions': [{'name': 'supervised physical exercise sessions', 'type': 'OTHER', 'description': 'Participants assigned to the supervised exercise group will perform a supervised routine of approximately 30 minutes, 2 days per week (Monday and Wednesday at the Txagorritxu hospital, and Tuesday and Thursday at the Santiago hospital from 7:15 to 7:45 and from 15:15 to 15:45).', 'armGroupLabels': ['supervised physical exercise sessions']}, {'name': 'unsupervised physical exercise', 'type': 'OTHER', 'description': 'For the non-supervised group, we will propose climbing the stairs from floor 0 to floor 7 three times during the working day and doing planks and stretching exercises outside of work. For the latter, an educational session will be given at the beginning of the study to explain how to perform them correctly.', 'armGroupLabels': ['unsupervised physical exercise sessions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01009', 'city': 'Vitoria-Gasteiz', 'state': 'Alava', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'RAQUEL COBOS, phD', 'role': 'CONTACT', 'email': 'raquel.coboscampos@osakidetza.eus', 'phone': '+34945207935'}], 'facility': 'Araba university hospital', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}, {'zip': '01009', 'city': 'Vitoria-Gasteiz', 'state': 'Alava', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Raquel Cobos', 'role': 'CONTACT', 'email': 'raquel.coboscampos@osakidetza.eus'}], 'facility': 'Bioaraba Health Research Institute', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}], 'centralContacts': [{'name': 'Raquel Cobos', 'role': 'CONTACT', 'email': 'raquel.coboscampos@osakidetza.eus', 'phone': '945207935'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioaraba Health Research Institute', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}