Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-01-17 @ 2:39 PM
Study NCT ID:
NCT02165150
Status:
COMPLETED
Last Update Posted:
2014-06-17
First Post:
2014-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Senior Elastic Band (SEB) on Institutional Elders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-13', 'studyFirstSubmitDate': '2014-06-11', 'studyFirstSubmitQcDate': '2014-06-13', 'lastUpdatePostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in physical functional fitness at 3, 6, 9, 12, 15 months', 'timeFrame': 'participants will be followed for 15 months', 'description': 'including cardiovascular-respiratory function, body flexibility, muscle power/muscle endurance, and balance'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in sleep quality at 3, 6, 9, 12, 15 months', 'timeFrame': 'participants will be followed for 15 months', 'description': 'measured by PSQI'}, {'measure': 'Change from baseline in depression at 3, 6, 9, 12, 15 months', 'timeFrame': 'participants will be followed for 15 months', 'description': 'measured by Taiwanese Depression Questionnaire (TDQ)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Elastic Band', 'Institutional Elders', 'Functional Fitness', 'Sleep Quality', 'Depression'], 'conditions': ['Institutional Older Adults']}, 'descriptionModule': {'briefSummary': 'The goals of this research project are: 1) to develop and evaluate the safety and feasibility of the Senior Elastic Band (SEB) exercise program for elderly residents in long term care facilities, 2) to evaluate the long-term effects of the SEB on physical functional fitness and sleep quality of elderly residents in long term care facilities, and 3) to investigate the compliance of elderly residents with long-term SEB exercises.', 'detailedDescription': 'A three-year, longitudinal, triangulation research method will be used. The study purpose of the first year is to develop a safe and appropriate SEB program for the elderly residents in long term care facilities using Delphi survey with a panel of 12 experts and pilot-testing on a group of 15-20 elderly residents in long term care facilities. In the second year of the study, a quasi-experimental, non-equivalent control group design will be used to evaluate the effects of the SEB exercise program on the physical functional fitness (cardiovascular-respiratory function, body flexibility, muscle power/muscle endurance, and balance) and sleep quality of elderly residents in long term care facilities. Through the convenience sampling strategy, a total of four long term care facilities with approximately 120 elders in Kaohsiung will be recruited and randomly assigned based on the resided facilities to a SEB experimental group or a waiting-list control group. The subjects in the experimental group will receive the SEB interventions lead by the certified instructors, three times per week, 40 minutes per practice for six months; the subjects in the waiting-list control group will remain regular daily activities in the facilities. All subjects will receive one pre-test and two post-tests three months apart during the study. In the third year, the elderly participants will continue practicing the SEB guided by a VCD for another nine months, and the compliance of the participants toward regular SEB exercise and its long-term effects on the physical functional fitness and sleep quality outcomes will be tested with additional three post-tests, three months apart.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elderly residents aged 65 and over\n* Mandarin or Taiwanese speakers\n* have been living in the facility for at least 3 months\n* able to stand alone without assistive devices\n* cognitively alert and able to verbally state their name, address, and answer questions.\n\nExclusion Criteria:\n\n* participants with severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses'}, 'identificationModule': {'nctId': 'NCT02165150', 'acronym': 'SEB', 'briefTitle': 'Senior Elastic Band (SEB) on Institutional Elders', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University'}, 'officialTitle': 'Development, Application , and Evaluation of the Senior Elastic Band (SEB) Exercise Program for Elderly Residents in Long-term Care Facilities', 'orgStudyIdInfo': {'id': 'FYH-IRB-098-12-02'}, 'secondaryIdInfos': [{'id': 'NSC99-2628-B-037-066-MY3', 'type': 'OTHER_GRANT', 'domain': 'National Science Council'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wheelchair-bound Senior Elastic Band', 'description': 'WSEB interventions three times per week, 40 minutes per practice', 'interventionNames': ['Other: Wheelchair-bound Senior Elastic Band exercise program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'routine care'}], 'interventions': [{'name': 'Wheelchair-bound Senior Elastic Band exercise program', 'type': 'OTHER', 'description': 'three times per week, 40 minutes per practice', 'armGroupLabels': ['Wheelchair-bound Senior Elastic Band']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80708', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Kuei-Min Chen, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaohsiung Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kuei-Min Chen, Ph.D., RN.', 'investigatorAffiliation': 'Kaohsiung Medical University'}}}}