Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT06660706
Status:
RECRUITING
Last Update Posted:
2024-10-28
First Post:
2024-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Exercise Intervention on Skeletal Muscle and Other Organs in Aged Population and the Discovery of Associated Circulating Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-25', 'studyFirstSubmitDate': '2024-10-25', 'studyFirstSubmitQcDate': '2024-10-25', 'lastUpdatePostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Physical performance', 'timeFrame': 'baseline, 6 month', 'description': 'Change in hand-grip strength (kg), or six-meter walking speed (m/s), or 5 times sit to stand test from baseline to 6 months in all participants'}], 'secondaryOutcomes': [{'measure': 'Change in DHEA-S', 'timeFrame': 'baseline, 6 month', 'description': 'Change in DHEA-S concentration from baseline to 6 months in all participants'}, {'measure': 'Change in IGF-1', 'timeFrame': 'baseline, 6 month', 'description': 'Change in IGF-1 concentration from baseline to 6 months in all participants'}, {'measure': 'Change in hs-CRP', 'timeFrame': 'baseline, 6 month', 'description': 'Change in hs-CRP concentration from baseline to 6 months in all participants'}, {'measure': 'Change in Myostatin', 'timeFrame': 'baseline, 6 month', 'description': 'Change in Myostatin concentration from baseline to 6 months in all participants'}, {'measure': 'Change in Activing A', 'timeFrame': 'baseline, 6 month', 'description': 'Change in Activing A concentration from baseline to 6 months in all participants'}, {'measure': 'Change in Follistatin', 'timeFrame': 'baseline, 6 month', 'description': 'Change in Follistatin concentration from baseline to 6 months in all participants'}, {'measure': 'Change in Relative appendicular skeletal muscle index (RASM)', 'timeFrame': 'baseline, 6 month', 'description': 'Change in RASM from baseline to 6 months in all participants'}, {'measure': 'Change in body fat %', 'timeFrame': 'baseline, 6 month', 'description': 'Change in body fat % from baseline to 6 months in all participants'}, {'measure': 'Change in Cognitive performance', 'timeFrame': 'baseline, 6 month', 'description': 'Change in Montreal Cognitive Assessment (MoCA), or Mini-mental state examination (MMSE) from baseline to 6months in all participants'}, {'measure': 'Change from lipoproflie', 'timeFrame': 'baseline, 6 month', 'description': 'Change in Total Cholesterol, Triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol from baseline to 6months in all participants'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aging', 'muscle health', 'body composition'], 'conditions': ['Age-related Functional Decline']}, 'descriptionModule': {'briefSummary': 'This project aims to investigate the intricate interplay between skeletal muscle and adipose tissue during the aging process by integrating human studies. Utilizing interventional research and randomized trials combined with examining blood samples from elderly individuals engaged in exercise, we aim to investigate the effects of exercise on muscle health and explore the underlying mechanisms of muscle aging and related biomarkers. Interdisciplinary research allowed us to investigate the systemic impact of exercise on muscles. This approach allowed us to gain a better understanding of the interconnectedness of skeletal muscle and adipose tissue in the aging process and devise efficient strategies to reverse age-related changes. These findings hold promise for promoting a future society where long and healthy life is achievable for all.', 'detailedDescription': 'This study is a randomized controlled trial of 6-month multidomain intervention program among community-living older adults with early physical impairments.\n\nInclusion criteria are: (1) community-dwelling adults aged ≥ 65 years, (2) slow gait speed (\\<1 m/s in 6-meter walk test) or weakness (dominant handgrip strength \\<28 kg in men, \\<18 kg in women); subjects with the following conditions will be excluded: (1) established diagnosis of dementia, Parkinsonism or other neurodegenerative disease (2) disable status: mobilitylimiting conditions, (3) active, acute diseases receiving treatment, such as cancer, heart failure, COPD and so on, (4) estimated life expectancy \\<12 months, (5) current nursing home residents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged ≥ 65 years\n* slow gait speed (\\<1 m/s in 6-meter walk test) or weakness (dominant handgrip strength \\<28 kg in men, \\<18 kg in women)\n\nExclusion Criteria:\n\n* established diagnosis of dementia, Parkinsonism or other mobility-limiting, disable conditions\n* active, acute diseases receiving treatment, such as cancer, heart failure, COPD and so on\n* estimated life expectancy \\<12 months\n* current nursing home residents'}, 'identificationModule': {'nctId': 'NCT06660706', 'briefTitle': 'The Effects of Exercise Intervention on Skeletal Muscle and Other Organs in Aged Population and the Discovery of Associated Circulating Biomarkers', 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': 'The Effects of Exercise Intervention on Skeletal Muscle and Other Organs in Aged Population and the Discovery of Associated Circulating Biomarkers', 'orgStudyIdInfo': {'id': 'NYCU112162AF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multidomain intervention group', 'description': 'The multidomain intervention program is designed as structural training sessions of 2-hour training sessions two times per week.', 'interventionNames': ['Behavioral: Multi-domain intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care group', 'description': 'Provide conventional health educations in every three-month interval'}], 'interventions': [{'name': 'Multi-domain intervention', 'type': 'BEHAVIORAL', 'description': 'Each session comprises of 45 minutes physical fitness activities targeting on muscle strength, balance, and flexibility; 1-hour cognitive training primarily on reasoning and memory exercises; and 15-minute for nutritional advices based on national diet guidelines for older adults', 'armGroupLabels': ['Multidomain intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Li-Ning Peng, M.D., PhD', 'role': 'CONTACT', 'email': 'lining.peng@gmail.com', 'phone': '+886-28239014'}], 'facility': 'Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Li-Ning Peng, M.D., PhD', 'role': 'CONTACT', 'email': 'lining.peng@gmail.com', 'phone': '+886-28239014'}], 'overallOfficials': [{'name': 'Li-Ning Peng, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Yang Ming Chiao Tung University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health Research Institutes, Taiwan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Li-Ning Peng', 'investigatorAffiliation': 'National Yang Ming Chiao Tung University'}}}}