Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-25 @ 1:03 AM
Study NCT ID:
NCT01646632
Status:
UNKNOWN
Last Update Posted:
2012-07-20
First Post:
2012-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Intervention in Institutionalized Elderly People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-18', 'studyFirstSubmitDate': '2012-07-11', 'studyFirstSubmitQcDate': '2012-07-18', 'lastUpdatePostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADL performance in institutionalized elderly people', 'timeFrame': '16 weeks', 'description': 'the intervention was either an group -based exercise program (the experimental intervention), or a recreational program (the control intervention), lasting 16 weeks, two times a week, including one hour sessions'}], 'secondaryOutcomes': [{'measure': 'Physical fitness in institutionalized older people', 'timeFrame': '16 weeks', 'description': 'the intervention was either an group -based exercise program (the experimental intervention), or a recreational program (the control intervention), lasting 16 weeks, two times a week, including one hour sessions'}, {'measure': 'Care dependency in institutionalized older people', 'timeFrame': '16 weeks', 'description': 'the intervention was either an group -based exercise program (the experimental intervention), or a recreational program (the control intervention), lasting 16 weeks, two times a week, including one hour sessions'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['institutionalized ADL fitness care-dependency'], 'conditions': ['Fragility', 'Physical Disability']}, 'referencesModule': {'references': [{'pmid': '20798482', 'type': 'BACKGROUND', 'citation': 'Weening-Dijksterhuis E, Kamsma YP, van Heuvelen MJ. Psychometric properties of the PAT: an assessment tool for ADL performance of older people living in residential homes. Gerontology. 2011;57(5):405-13. doi: 10.1159/000318151. Epub 2010 Aug 26.'}, {'pmid': '20881587', 'type': 'BACKGROUND', 'citation': 'Weening-Dijksterhuis E, de Greef MH, Scherder EJ, Slaets JP, van der Schans CP. Frail institutionalized older persons: A comprehensive review on physical exercise, physical fitness, activities of daily living, and quality-of-life. Am J Phys Med Rehabil. 2011 Feb;90(2):156-68. doi: 10.1097/PHM.0b013e3181f703ef.'}]}, 'descriptionModule': {'briefSummary': 'Questions: Does an evidence-based exercise program increase activities of daily living and physical fitness in institutionalized older adults? Does this program decrease the care dependency of institutionalized older adults? Design: A randomized control trial using group-based exercise was performed in 14 assisted-living facilities for the elderly (\\>70 years old).\n\nOutcome measures: Outcome measures were performance on ADL, physical fitness, and care dependency measures. The exercise program comprised group-based progressive resistance training, balance training, and functional training. The control intervention comprised social group meetings.', 'detailedDescription': 'To improve physical fitness, a combined exercise program including progressive resistance training, balance training, and functional training will be used in a sample of institutionalized elderly people. The exercise program has a frequency of 2 times a week and a duration of 16 weeks. The intensity is moderate, measured on a 0-10 scale. The level of intensity is specified as follows: on a 10- point scale, where no movement is 0 and maximal effort of a muscle group is 10, moderate-intensity effort is a 5 or 6, and high- intensity effort is a 7 or 8. There is currently insufficient evidence that a combined exercise program, developed to improve physical fitness, can improve ADL performance and care dependency also.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 70 and older\n* Being able to walk at least 10 meters\n* Not cognitive impaired\n\nExclusion Criteria:\n\n* Dementia\n* Severe hart failure\n* Progressive neurological diseases'}, 'identificationModule': {'nctId': 'NCT01646632', 'acronym': 'BENENFIT', 'briefTitle': 'Exercise Intervention in Institutionalized Elderly People', 'organization': {'class': 'OTHER', 'fullName': 'Hanze University of Applied Sciences Groningen'}, 'officialTitle': 'Effects of Exercise on ADL Performance, Physical Fitness, and Care Dependency in Institutionalized Elderly People', 'orgStudyIdInfo': {'id': 'ABR NL 24558.042.09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical exercise intervention', 'description': 'Progressive resistance training, balance training, functional training', 'interventionNames': ['Behavioral: Physical exercise intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Lifestyle counseling', 'description': 'Recreational sessions', 'interventionNames': ['Behavioral: Lifestyle counseling']}], 'interventions': [{'name': 'Physical exercise intervention', 'type': 'BEHAVIORAL', 'otherNames': ['strength training', 'muscle training', 'coordination training'], 'description': 'the experimental intervention included group- based progressive resistance training, balance training, and functional training, two times a week, one hour sessions, lasting 16 weeks.', 'armGroupLabels': ['Physical exercise intervention']}, {'name': 'Lifestyle counseling', 'type': 'BEHAVIORAL', 'otherNames': ['leisure time activities without physical activity'], 'description': "the control intervention included recreational sessions, including talks, video's, music, board games etc. No physical activity was involved in the control intervention.", 'armGroupLabels': ['Lifestyle counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9714 CE', 'city': 'Groningen', 'state': 'Provincie Groningen', 'country': 'Netherlands', 'facility': 'Hanze University Applied Sciences', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Cees P van der Schans, Prof., PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hanze University Applied Science Groningen The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanze University of Applied Sciences Groningen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Medical Center Groningen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'researcher', 'investigatorFullName': 'Mrs. Elizabeth Weening-Dijksterhuis', 'investigatorAffiliation': 'Hanze University of Applied Sciences Groningen'}}}}