Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-01-01 @ 1:22 AM
Study NCT ID:
NCT06519695
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-31
First Post:
2024-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Intervention for Pre-frail Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2024-07-19', 'studyFirstSubmitQcDate': '2024-07-19', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reversal of pre-frailty', 'timeFrame': '24 weeks', 'description': 'Reversal rate of pre-frailty (from pre-frail to robust in this study)'}], 'secondaryOutcomes': [{'measure': 'Self-efficacy for exercise', 'timeFrame': '24 weeks', 'description': "The Self-Efficacy for Exercise Scale was designed to test people's confidence to continue exercising despite barriers to exercise. The score of each item ranged from 0 to 10, with higher scores representing greater exercise self-efficacy."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['frail', 'exercise'], 'conditions': ['Older Adults']}, 'referencesModule': {'references': [{'pmid': '35231098', 'type': 'RESULT', 'citation': 'Dun Y, Hu P, Ripley-Gonzalez JW, Zhou N, Li H, Zhang W, Chen M, Zheng Q, Cui N, Wu S, Liu S. Effectiveness of a multicomponent exercise program to reverse pre-frailty in community-dwelling Chinese older adults: a randomised controlled trial. Age Ageing. 2022 Mar 1;51(3):afac026. doi: 10.1093/ageing/afac026.'}, {'pmid': '26389979', 'type': 'RESULT', 'citation': 'McMahon SK, Wyman JF, Belyea MJ, Shearer N, Hekler EB, Fleury J. Combining Motivational and Physical Intervention Components to Promote Fall-Reducing Physical Activity Among Community-Dwelling Older Adults: A Feasibility Study. Am J Health Promot. 2016 Nov;30(8):638-644. doi: 10.4278/ajhp.130522-ARB-265. Epub 2016 Jun 16.'}, {'pmid': '33189414', 'type': 'RESULT', 'citation': 'Barrachina-Igual J, Martinez-Arnau FM, Perez-Ros P, Flor-Rufino C, Sanz-Requena R, Pablos A. Effectiveness of the PROMUFRA program in pre-frail, community-dwelling older people: A randomized controlled trial. Geriatr Nurs. 2021 Mar-Apr;42(2):582-591. doi: 10.1016/j.gerinurse.2020.10.014. Epub 2020 Nov 12.'}, {'pmid': '39478450', 'type': 'DERIVED', 'citation': 'Fang J, Ren J, Wang J, Qiu X, Zhang S, Yuan S, Wu L, Xie L. Combining motivational and exercise intervention components to reverse pre-frailty and promote self-efficacy among community-dwelling pre-frail older adults: a randomized controlled trial. BMC Geriatr. 2024 Oct 30;24(1):896. doi: 10.1186/s12877-024-05464-6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effectiveness of multicomponet exercise for reversing pre-frailty among Chinese community-dwelling pre-frail older adults.Meanwhile,to explore the effects of multicomponent exercise on self-efficiency of exercise.', 'detailedDescription': 'Based on the Wellness Motivation Theory (WMT), this study aimed to develop a theoretical model of exercise intervention for the pre-frail elderly. This study was to establish an exercise intervention mode, conduct empirical research through randomized controlled trials, and propose improvement strategies, aiming at improving the effectiveness of health management services for the community-dwelling pre-frail elderly. Specific research objectives are as follows:\n\n1. To develop a theoretical model of exercise intervention for the pre-frail elderly based on the WMT, and to explain the operation mechanism of the exercise intervention mode.\n2. An empirical study was conducted to verify the applicability and effectiveness of the exercise intervention mode, analyze the influencing factors of the intervention effect, and propose optimization strategies to improve the exercise intervention effect of the elderly in pre-frailty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* community-dwelling prefrail older adults based on Fried frailty phenotype;\n* age≥60 years,≤85 years;\n* not engaged in regular physical activity or exercise programs in the previous 6 months;\n* no hearing or visual impairment that might hinder communication;\n* Written informed consent.\n\nExclusion Criteria:\n\n* physical restrictions to perform the tests and/or exercises,\n* cognitive impairment;\n* medical contraindications for participation in an exercise program.'}, 'identificationModule': {'nctId': 'NCT06519695', 'briefTitle': 'Exercise Intervention for Pre-frail Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Hangzhou Normal University'}, 'officialTitle': 'A Study on the Exercise Intervention Mode of Modern Exercises and Traditional Chinese Exercises for the Community-Dwelling Pre-frail Elderly: Based on the Wellness Motivation Theory', 'orgStudyIdInfo': {'id': 'JRen'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multicomponent exercises group', 'description': 'Multicomponent exercise intervention under the guidance of the wellness motivation theory', 'interventionNames': ['Behavioral: Multicomponent exercises']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Health education about exercise only once.'}], 'interventions': [{'name': 'Multicomponent exercises', 'type': 'BEHAVIORAL', 'description': 'Performed exercise three times a week, one time at a community health service station and two times at home', 'armGroupLabels': ['Multicomponent exercises group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '311121', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Hangzhou Normal University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Ren Jianping', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hangzhou Normal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hangzhou Normal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director of department', 'investigatorFullName': 'Jianping Ren', 'investigatorAffiliation': 'Hangzhou Normal University'}}}}