Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT06182020
Status:
UNKNOWN
Last Update Posted:
2023-12-26
First Post:
2023-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Integrated Care Involving Peripheral Functional Magnetic Stimulation for Sarcopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'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': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2023-11-23', 'studyFirstSubmitQcDate': '2023-12-13', 'lastUpdatePostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body composition', 'timeFrame': 'Before the intervention, and 1-2 weeks after the 8-week intervention', 'description': 'We use dual energy x-ray absorptiometry to evaluate the muscle mass (kg/m2) in the subjects.'}, {'measure': 'Handgrip strength', 'timeFrame': 'Before the intervention, and 1-2 weeks after the 8-week intervention', 'description': 'We use a dynamometer to measure the handgrip strength (kg)'}, {'measure': '5-time chair stand test', 'timeFrame': 'Before the intervention, and 1-2 weeks after the 8-week intervention', 'description': 'We measure the time of a subject to transfer from a seated to a standing position and back to sitting five times.'}, {'measure': '6-meter walk', 'timeFrame': 'Before the intervention, and 1-2 weeks after the 8-week intervention', 'description': 'We measure the time of a subject to walk with the usual speed straightly for 6 meters.'}], 'secondaryOutcomes': [{'measure': 'Leg circumference', 'timeFrame': 'Before the intervention, and 1-2 weeks after the 8-week intervention', 'description': 'We measure the largest calf circumference with seated position with knee flexed in 90 degrees.'}, {'measure': 'Cytokines related to sarcopenia', 'timeFrame': 'Before the intervention, and 1-2 weeks after the 8-week intervention', 'description': 'We will check the concentrations of cytokines including the c-reactive protein from our subjects.'}, {'measure': 'Nutritional status', 'timeFrame': 'Before the intervention, and 1-2 weeks after the 8-week intervention', 'description': "We use the questionnaire Mini Nutritional Assessment to evaluate the subjects' nutritional status."}, {'measure': 'Activity level', 'timeFrame': 'Before the intervention, and 1-2 weeks after the 8-week intervention', 'description': "We use the International Physical Activity Questionnaire to evaluate the subjects' activity levels."}, {'measure': 'Life quality', 'timeFrame': 'Before the intervention, and 1-2 weeks after the 8-week intervention', 'description': "We use the EuroQol-5 dimensions (EQ-5D) and Taiwan Short Form-36 questionnaires to evaluate the subjects' health life quality."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sarcopenia', 'Functional magnetic stimulation'], 'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical randomized trial is to test whether an integrated care involving peripheral functional magnetic stimulation and nutritional supplement is beneficial in population with age-related sarcopenia, as compared to usual care.', 'detailedDescription': 'We will recruit participants with sarcopenia or possible sarcopenia. The participants will be divided into 2 groups. One group, the "integrated care" group, will receive both the peripheral functional magnetic stimulation to both the upper and lower limbs and nutritional supplement for consecutive 8 weeks. The other group, the "usual care" group, will receive an educational digital versatile disc (DVD) and a handbook for exercise suggestions on sarcopenia. We will compare before and after the intervention about the body composition, handgrip strength, 5-time chair stand test, 6-meter walk, and blood test for C-reactive protein and other cytokines related to sarcopenia. The participant\'s nutritional condition, activity level, life quality will also be analyzed via questionnaires before and after the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 65 to 90\n* Can walk independently for over 15 minutes\n* Diagnosed with possible sarcopenia or sarcopenia (by Asian Working Group for Sarcopenia: 2019 Consensus Update onSarcopenia Diagnosis and Treatment)\n\nExclusion Criteria:\n\n* Cognitive impairment\n* History of cerebrovascular disease\n* Deep vein thrombosis\n* Malignancy under treatment\n* Coagulopathy\n* Serious orthopedic condition over limbs\n* Inability to walk independently without assistive device\n* Any other conditions not suggested to performance exercise\n* Medical implants (e.g. pacemaker, defibrillator, deep brain nerve stimulation, infusion pump, etc.)'}, 'identificationModule': {'nctId': 'NCT06182020', 'briefTitle': 'Effect of Integrated Care Involving Peripheral Functional Magnetic Stimulation for Sarcopenia', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Effect of Integrated Care Involving Peripheral Functional Magnetic Stimulation and Nutritional Supplement for Age-related Sarcopenia', 'orgStudyIdInfo': {'id': '202309121RIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Integrated care', 'description': 'Participants in this group will receive both the peripheral functional magnetic stimulation to both the upper and lower limbs and nutritional supplement for consecutive 8 weeks.', 'interventionNames': ['Device: Peripheral functional magnetic stimulation (ISKRA MEDICAL TESLA Former prestige Magneto therapy)', 'Dietary Supplement: Nutritional supplementation (ENSURE HIGH CALCIUM)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Participants in this group will receive an educational DVD and one session of oral instructions on general care and exercise suggestions for sarcopenia.', 'interventionNames': ['Behavioral: Education']}], 'interventions': [{'name': 'Peripheral functional magnetic stimulation (ISKRA MEDICAL TESLA Former prestige Magneto therapy)', 'type': 'DEVICE', 'description': 'The peripheral functional magnetic stimulation will be conducted 30 minutes a session, 2 sessions per week, for consecutive 8 weeks. The stimulation will be placed over bilateral forearm flexor muscles and bilateral thighs over rectus femoris muscles.', 'armGroupLabels': ['Integrated care']}, {'name': 'Nutritional supplementation (ENSURE HIGH CALCIUM)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The nutritional supplementation includes 7 cans of "ENSURE HIGH CALCIUM" per week for 8 consecutive weeks.', 'armGroupLabels': ['Integrated care']}, {'name': 'Education', 'type': 'BEHAVIORAL', 'description': 'The education includes a DVD and one session of oral instructions on general care and exercise suggestions for sarcopenia.', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital Bei-Hu Branch', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Shao-Yu Chi', 'role': 'CONTACT', 'email': 'shaoyuchi.tw@gmail.com', 'phone': '+886972653975'}], 'overallOfficials': [{'name': 'Shao-Yu Chi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital Bei-Hu Branch'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}