Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-01-01 @ 9:45 AM
Study NCT ID:
NCT03898492
Status:
COMPLETED
Last Update Posted:
2019-04-02
First Post:
2019-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality Assessment of a Training Period for Physical and Mentally Disabled People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}], 'ancestors': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One intervention group and one control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-01', 'studyFirstSubmitDate': '2019-03-26', 'studyFirstSubmitQcDate': '2019-04-01', 'lastUpdatePostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body mass index', 'timeFrame': 'Through study completion, an average of 8 weeks', 'description': 'weight (kg)/height (m) x height (m)'}, {'measure': 'Blood pressure', 'timeFrame': 'Through study completion, an average of 8 weeks', 'description': 'Diastolic pressure (mmHg) Systolic pressure (mmHg)'}, {'measure': 'Completed chair stands', 'timeFrame': 'Through study completion, an average of 8 weeks', 'description': 'Number of completed chair stands'}, {'measure': 'Aastrand test', 'timeFrame': 'Through study completion, an average of 8 weeks', 'description': 'Bike test to measure the physical fitness.'}, {'measure': 'Waist circumference', 'timeFrame': 'Through study completion, an average of 8 weeks', 'description': 'Measured in cm'}, {'measure': 'Physical activity', 'timeFrame': 'During test session - 2-3 days', 'description': 'Number of steps and active minutes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Disabled Persons', 'Exercise']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to evaluate the effect of a 8 week training period compared with control group in physical and mentally disabled adults. The effect was evaluated in relation to their physical status. Furthermore, physical activity was measured using steps and active minutes.', 'detailedDescription': 'This study aimed at making a quality assessment of a 8 week training period for adults with physical and mental disabilities. A control group was added to compare the effect of the training with no training. Before the training period the participants were tested in relation to their physical status: weight, height, fat%, blood pressure, Aastrand test, chair stand test and waist circumference. In addition to this, the participants were instructed to wear an accelerometer to measure step and active minutes for 2-3 days a work.\n\nThe staff at the day center, where the participants works in daytime, were responsible for the physical training 2 times/week for 8 weeks. The training was an hour of combined aerobic, strength, balance and flexibility training.\n\nThe participants were tested after the training period using the same test-protocol as before.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* User of the centers included in the study\n* Being able to stand alone\n* Being able to use an exercise bike\n* Being able to understand danish\n\nExclusion Criteria:\n\n* Pregnancy\n* Pacemaker\n* Not being able to stand up by themselves'}, 'identificationModule': {'nctId': 'NCT03898492', 'briefTitle': 'Quality Assessment of a Training Period for Physical and Mentally Disabled People', 'organization': {'class': 'OTHER', 'fullName': 'University College of Northern Denmark'}, 'officialTitle': 'Quality Assessment of a Training Period for Physical and Mentally Disabled People', 'orgStudyIdInfo': {'id': 'FOU-UU-2018-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention', 'description': 'The participants in this group participated in exercise two times/week for 8 weeks', 'interventionNames': ['Other: Physical training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The participants in the control group were instructed to maintain their daily routines.'}], 'interventions': [{'name': 'Physical training', 'type': 'OTHER', 'description': 'Training two times/week for an hour each time in 8 weeks. The training included strength training, aerobic training, balance training and flexibility training. The training was modified to the participants and initiated by the staff at the center.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9220', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Department of Physiotherapy, University College of Northern Jutland', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Dorte Drachmann, Msc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University College of Northern Jutland, Denmark. Department of Physiotherapy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College of Northern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'TRYG Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}