Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 4:43 AM
Study NCT ID:
NCT07398495
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Training Effects in Middle-Aged and Older Adults With Diabetic Sarcopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-04', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-04', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Function (5TSTS)', 'timeFrame': 'Change from Baseline at Week 12 and Week 24', 'description': 'The Five-Times Sit-to-Stand Test (5TSTS) assesses lower limb muscle power. Participants are asked to stand up and sit down five times as quickly as possible with arms folded. The time to completion is recorded in seconds and analyzed as a continuous variable. Longer completion times indicate poorer physical performance'}, {'measure': 'Handgrip Strength (HGS)', 'timeFrame': 'Change from Baseline at Week 12 and Week 24', 'description': 'Measured using a digital dynamometer (e.g., Jamar or equivalent). Participants perform the test in a standing position with the arm fully extended. Two trials are performed for each hand, and the highest value (kg) is used for analysis. Low muscle strength is defined according to AWGS 2019 criteria (\\<28 kg for men and \\<18 kg for women).'}, {'measure': 'Skeletal Muscle Mass Index (SMI)', 'timeFrame': 'Change from Baseline at Week 12 and Week 24', 'description': 'Determined by bioelectrical impedance analysis (BIA). Appendicular skeletal muscle mass (ASM, kg) is calculated as the sum of lean mass from both arms and legs. SMI is expressed as ASM divided by height squared (kg/m²). Low muscle mass is defined according to AWGS 2019 cut-off values (\\<7.0 kg/m² for men and \\<5.7 kg/m² for women).'}, {'measure': 'Sarcopenia Risk (SARC-CalF)', 'timeFrame': 'Change from Baseline at Week 12 and Week 24', 'description': 'Assessed using the SARC-CalF questionnaire, combining the SARC-F (5 items: strength, walking, rising, climbing stairs, falls; scored 0-10) with calf circumference measurement. Calf circumference ≤34 cm (men) or ≤33 cm (women) adds 10 points to the score. A total SARC-CalF score ≥11 indicates a high risk of sarcopenia.'}], 'secondaryOutcomes': [{'measure': 'Glycated Hemoglobin (HbA1c)', 'timeFrame': 'Change from Baseline at Week 12 and Week 24', 'description': 'Metabolic control evaluated by HbA1c levels. Venous blood samples are collected after an overnight fast and analyzed using standardized high-performance liquid chromatography (HPLC). Values are reported as percentages.'}, {'measure': 'Quality of Life (SF-12)', 'timeFrame': 'Change from Baseline at Week 12 and Week 24', 'description': 'Assessed using the 12-Item Short Form Health Survey (SF-12). The survey covers eight domains summarized into two composite scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scores range from 0 to 100, with higher scores indicating better quality of life.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus (T2DM)', 'Sarcopenia']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effects of a 12-week multimodal exercise intervention on middle-aged and older adults (aged 45\\~85 years) with Type 2 Diabetes Mellitus (T2DM). The program combines supervised training, home-based sessions, and digital support to improve muscle function, physical performance, metabolic control, and quality of life.', 'detailedDescription': 'Middle-aged and older adults with T2DM, particularly in Asian populations, face a heightened risk of sarcopenia. This condition leads to a decline in muscle mass and function, negatively impacting quality of life. Effective interventions are urgently needed to slow disease progression. This randomized controlled trial will recruit 58 adults. Participants will be randomly assigned to either a control group or an intervention group. The intervention involves a multimodal exercise program and educational materials, while the control group receives standard health education. Assessments will be conducted at baseline, week 12, and week 24 to evaluate physical function, sarcopenia risk, metabolic control, and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with both Type 2 Diabetes Mellitus (T2DM) and sarcopenia.\n* Maintained on a stable regimen of oral hypoglycemic agents.\n* Aged 45 years or older.\n* Capable of communicating effectively in Mandarin or Taiwanese.\n* Willing to provide informed consent or have it obtained from a legally authorized representative.\n\nExclusion Criteria:\n\n* • Limited limb or joint function that prevents exercise (e.g., recent fractures or dislocations).\n\n * Communication barriers or severe emotional/psychological issues (e.g., uncontrolled depression or severe mental illness).\n * Severe cognitive impairment (e.g., dementia).\n * End-stage renal disease (ESRD).\n * Major comorbidities or complications, including active diabetic foot ulcers, amputation, recent myocardial infarction, severe autonomic neuropathy, or a history of stroke within the last 3 years.'}, 'identificationModule': {'nctId': 'NCT07398495', 'briefTitle': 'Multimodal Training Effects in Middle-Aged and Older Adults With Diabetic Sarcopenia', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Effects of Multimodal Training on Muscle Function and Glucose Metabolism in Middle-Aged and Older Adults With Type 2 Diabetes Mellitus and Sarcopenia', 'orgStudyIdInfo': {'id': 'CSH-2026-A-036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group (Multimodal Exercise)', 'description': '• Arm Description: Participants in this group will engage in a 12-week multimodal exercise program. The program includes supervised training sessions, home-based exercises, and digital support. They will also receive a "Diabetes and Muscle Health Handbook" to guide their training.', 'interventionNames': ['Behavioral: Multimodal Exercise Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group (Standard Care)', 'description': 'Participants in this group will serve as the control. They will receive a "Nutrition and Muscle Health Education Sheet" at the beginning of the study. They will not participate in the multimodal exercise program and will continue with their routine health management based on existing medical advice.'}], 'interventions': [{'name': 'Multimodal Exercise Program', 'type': 'BEHAVIORAL', 'otherNames': ['Control Group'], 'description': 'Participants will engage in a 12-week multimodal exercise program comprising supervised training sessions, home-based exercises, and digital support. To facilitate adherence and proper technique, participants will also receive a "Diabetes and Muscle Health Handbook" as a training guide.', 'armGroupLabels': ['Intervention Group (Multimodal Exercise)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '402306', 'city': 'Taichung', 'state': 'Taiwan', 'country': 'Taiwan', 'contacts': [{'name': 'WU YUEH CHU', 'role': 'CONTACT', 'email': 'yueh.chu46240@gmail.com', 'phone': '886-4-24739595', 'phoneExt': '20340'}], 'facility': 'Chung Shan Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'yueh chu wu WU YUEH CHU', 'role': 'CONTACT', 'email': 'yueh.chu46240@gmail.com', 'phone': '886-952680613'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Diabetes Educator', 'investigatorFullName': 'yueh chu wu', 'investigatorAffiliation': 'Chung Shan Medical University'}}}}