Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
Study NCT ID:
NCT06073106
Status:
RECRUITING
Last Update Posted:
2025-04-11
First Post:
2023-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Venous blood samples will be collected (50ml; about 10 teaspoons) for lab assay to assess metabolic health and inflammation'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2023-09-20', 'studyFirstSubmitQcDate': '2023-10-04', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence (rates) of Frailty', 'timeFrame': "Through study's data collection period, up to 4 years", 'description': 'Based off different outcomes determined in the study'}, {'measure': 'Severity of Frailty', 'timeFrame': 'For inpatient: Visit 1 (within 2 weeks of admission) to Visit 6 (end of 3rd year); For outpatient: Visit 1 (baseline) to Visit 4 (end of 3rd year)', 'description': "Based on CFS - 9-point clinical assessment tool evaluating an individual's frailty status; maximum score: 9; higher score indicates increased frailty."}], 'secondaryOutcomes': [{'measure': 'Body Composition Analysis (BCA)', 'timeFrame': 'For inpatient: Visit 3 (6 months post-event) to Visit 6 (end of 3rd year); For outpatient: Visit 1 (baseline) to Visit 4 (end of 3rd year)', 'description': 'Measured using weak electrical current passed from feet to estimate proportion of muscle, fat and water mass.'}, {'measure': 'Short Physical Performance Battery (SPPB)', 'timeFrame': 'For inpatient: Visit 1 (within 2 weeks of admission) to Visit 6 (end of 3rd year); For outpatient: Visit 1 (baseline) to Visit 4 (end of 3rd year)', 'description': 'Measures 3 components: (1) 5 times chair stand test; (2) Balance test; (3) Gait speed (4m walk test). Score from 0-12 with higher score indicating greater functional capacity.'}, {'measure': 'Hand Grip Strength (kg)', 'timeFrame': 'For inpatient: Visit 1 (within 2 weeks of admission) to Visit 6 (end of 3rd year); For outpatient: Visit 1 (baseline) to Visit 4 (end of 3rd year)', 'description': 'Measured seated with arms on a table bent to 90° using a dynamometer (mean of 3 readings will be recorded)'}, {'measure': 'Muscle Ultrasound imaging', 'timeFrame': 'For Inpatient: Visit 1 (within 2 weeks of admission), Visit 2 (1 week pre-discharge)', 'description': 'Determines state of muscle health of arm, thigh and jaw muscles through size, area and structural properties.'}, {'measure': 'FRAIL Questionnaire', 'timeFrame': 'For inpatient: Visit 1 (within 2 weeks of admission) to Visit 6 (end of 3rd year); For outpatient: Visit 1 (baseline) to Visit 4 (end of 3rd year)', 'description': '5-point questionnaire; (1-2 point) indicates pre-frail, (3-5 points) indicates frail'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Frailty', 'Multimorbidity', 'Osteosarcopaenia'], 'conditions': ['Stroke', 'Traumatic Brain Injury', 'Knee Osteoarthritis', 'Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '40409965', 'type': 'DERIVED', 'citation': 'Tay MRJ, Kim JM, Ong PL, Khin LW, Wong CJ, Kong KH, Tan BY, Lee ES, Sim SZ, Lim WS, Yam MGJ, Chew JL, Tan AWK, Sidarta A, Yee E, Chua KSG. Targeting osteosarcopenia and multimorbidity for frailty prevention through identification and deep phenotyping methods in healthy ageing and high-burden disease cohorts (OPTIMA-C): a longitudinal observational cohort study protocol for neuromusculoskeletal muscle health. BMJ Open. 2025 May 23;15(5):e094279. doi: 10.1136/bmjopen-2024-094279.'}]}, 'descriptionModule': {'briefSummary': 'The aging population and its accompanying burden from non-communicable chronic diseases predicts an increasing impact imposed by frailty on healthcare systems. This is due to a lack of normative data for older adults and reliable risk stratification methods to develop effective approaches to the prevention of frailty.\n\nIn this study, the investigators plan to form a common dataset for phenotype identification, risk stratification of frailty and its targeted treatment plans in the at-risk and mildly frail population.', 'detailedDescription': 'Osteosarcopaenia and multimorbidity have emerged as two key antecedent factors driving the cycle of frailty, leading to adverse outcomes. However, it remains unclear how multimorbidity and/or osteosarcopaenia act singly or in concert to influence the expression and trajectory of the frailty continuum.\n\nOPTIMA-C will develop unifying administrative and data platforms, exploring the feasibility of inclusive screening for sarcopaenia early during rehabilitation hospital stay. Early muscle ultrasound will also be utilised to determine key muscles possibly predictive of rehabilitation functional or global outcomes in the studied populations and their correlation with acute disease outcomes. Digital markers are quantified and correlations are investigated with physical, muscle and bone imaging findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in both outpatient and inpatient clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 50y\n2. Asian ethnicity\n3. First diagnosis (stroke, Traumatic Brain Injury (TBI), knee osteoarthritis, breast cancer)\n4. Living in community\n5. Able to understand 1 step simple commands\n6. For inpatients: (i) within 12 weeks of disease (stroke/TBI) onset, and (ii) within 2 weeks of rehabilitation ward admission\n7. For outpatients: (i) \\>6 months from initial diagnosis of first stroke, TBI, knee osteoarthritis or breast cancer, and (ii) at least standby assistance, modified independent or independent in ambulation with /without walking.\n\nExclusion Criteria:\n\n1. Nursing home or dormitory resident\n2. Non-resident status in Singapore (e.g. foreign worker, tourist, temporary visit pass)\n3. Impairments affecting understanding of questionnaires and tasks: e.g. severe deafness, severe visual impairment and severe /global aphasia,\n4. Presence of active fractures, dislocations, non-weight bearing status, burns, unhealed wounds, active skin infections/eczema and agitated behaviour or delirium\n5. Anticipated life expectancy \\< 1 year\n6. Presence of tracheostomy, ventilator, renal dialysis, end-organ failure\n7. Patients with disorders of consciousness.\n8. Pregnant or lactating participants\n\n For Knee Osteoarthritis patients only:\n9. Alternative diagnosis to knee OA e.g. Referred pain from hip or spine.\n10. Other forms of knee arthritis eg. Inflammatory, post traumatic\n11. Previous knee arthroplasty'}, 'identificationModule': {'nctId': 'NCT06073106', 'acronym': 'OPTIMA-C', 'briefTitle': 'Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Tan Tock Seng Hospital'}, 'officialTitle': 'Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention Through Identification and Deep Phenotyping Methods in Healthy Aging and High-burden Disease Cohorts.', 'orgStudyIdInfo': {'id': 'DSRB 2023/00105'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stroke', 'description': 'Both acutely admitted stroke patients undergoing rehabilitation and chronic recovered stroke outpatients will be recruited.'}, {'label': 'Traumatic Brain Injury', 'description': 'Both acutely admitted TBI patients undergoing rehabilitation and chronic recovered TBI outpatients will be recruited.'}, {'label': 'Breast Cancer', 'description': 'Only recovered breast cancer patients.'}, {'label': 'Knee Osteoarthritis', 'description': 'For patients with chronic knee osteoarthritis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '308433', 'city': 'Singapore', 'state': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Low Ai Mei Jaclyn', 'role': 'CONTACT', 'email': 'Jaclyn_AM_LOW@ttsh.com.sg'}], 'facility': 'Tan Tock Seng Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Low Ai Mei Jaclyn', 'role': 'CONTACT', 'email': 'Jaclyn_AM_LOW@ttsh.com.sg', 'phone': '68894580'}], 'overallOfficials': [{'name': 'Karen Chua', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tan Tock Seng Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tan Tock Seng Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rehabilitation Research Institute of Singapore (RRIS)', 'class': 'UNKNOWN'}, {'name': 'Woodlands Health (WH)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}