Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-02-03 @ 6:42 AM
Study NCT ID:
NCT02262104
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2013-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of an Exercise Program for Nursing Home Patients With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-02', 'studyFirstSubmitDate': '2013-11-23', 'studyFirstSubmitQcDate': '2014-10-09', 'lastUpdatePostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Berg Balance Scale', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Exercise', 'dementia', 'nursing home'], 'conditions': ['Dementia']}, 'referencesModule': {'references': [{'pmid': '28729326', 'type': 'DERIVED', 'citation': 'Kvael LAH, Bergland A, Telenius EW. Associations between physical function and depression in nursing home residents with mild and moderate dementia: a cross-sectional study. BMJ Open. 2017 Jul 20;7(7):e016875. doi: 10.1136/bmjopen-2017-016875.'}, {'pmid': '26630910', 'type': 'DERIVED', 'citation': 'Telenius EW, Engedal K, Bergland A. Long-term effects of a 12 weeks high-intensity functional exercise program on physical function and mental health in nursing home residents with dementia: a single blinded randomized controlled trial. BMC Geriatr. 2015 Dec 3;15:158. doi: 10.1186/s12877-015-0151-8.'}, {'pmid': '25974049', 'type': 'DERIVED', 'citation': 'Telenius EW, Engedal K, Bergland A. Effect of a high-intensity exercise program on physical function and mental health in nursing home residents with dementia: an assessor blinded randomized controlled trial. PLoS One. 2015 May 14;10(5):e0126102. doi: 10.1371/journal.pone.0126102. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of an exercise program on nursing home patients with dementia.', 'detailedDescription': 'The intervention group will be exercising one hour twice a week for 12 weeks. The participants will be doing intensive strength exercises and challenging balance exercises in groups of 4-6. Two physical therapists will be leading the intervention group. The control group will be meeting at the same frequency. Groups of 4-6 will be lead by an occupational therapist. The participants will be doing relaxation exercises, listen to music and social activities such as board games or indoor bowling.\n\nThe investigators will carry out three test periods:\n\n* Baseline testing before intervention start\n* Post test after 12 weeks of intervention\n* Follow-up 12 weeks after post test.\n\nThe testing will comprise:\n\n* Physical tests carried out by physiotherapists\n* Questionnaires concerning mental health and ADL (activities of daily living)\n* Cognition tests\n* Cortisol in saliva'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>55 years old\n* Living in nursing home\n* Able to stand with help from max 1\n* Able to walk 6 meters with or without walking aid\n\nExclusion Criteria:\n\n* Medically unstable\n* Longterm psychotic\n* Severe communication problems'}, 'identificationModule': {'nctId': 'NCT02262104', 'acronym': 'EXDEM', 'briefTitle': 'Effects of an Exercise Program for Nursing Home Patients With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Oslo Metropolitan University'}, 'officialTitle': 'Effects of an Exercise Program for Nursing Home Patients With Dementia - a Six Months Assessor Blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'REK 2012-1150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive exercise', 'description': 'Intensive strengthening and balance exercises 1 hour twice a week 12 weeks. Lead by physiotherapists.', 'interventionNames': ['Behavioral: Intensive exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Control group activities: Social activities one hour twice a week. Light physical activities, reading, conversation, games. Lead by occupational therapist or nursing staff', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Intensive exercise', 'type': 'BEHAVIORAL', 'description': 'Arm 1: Intervention group. Intensive strength exercise (12RM) for lower limb and balance exercises twice a week for 1 hour. Groups of max 3 participants lead by physiotherapist', 'armGroupLabels': ['Intensive exercise']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Arm 2: control. Social activity group with light exercise, reading, and games. Lead by occupational therapist or nursing staff', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo and Akershus University College of Applied Sciences', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Astrid Bergland', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo and Akershus University college of Applied science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo Metropolitan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian Centre for Ageing and Health', 'class': 'OTHER'}, {'name': 'University of Oslo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Fellow', 'investigatorFullName': 'Elisabeth Wiken Telenius', 'investigatorAffiliation': 'Oslo Metropolitan University'}}}}