Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention

Study Overview
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Brief Summary
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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. In 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.

Detailed Description
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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. OPTIMA-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.

Official Title
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Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention Through Identification and Deep Phenotyping Methods in Healthy Aging and High-burden Disease Cohorts.

Conditions
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Stroke, Traumatic Brain Injury, Knee Osteoarthritis, Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 50y Asian ethnicity First diagnosis (stroke, Traumatic Brain Injury (TBI), knee osteoarthritis, breast cancer) Living in community Able to understand 1 step simple commands For inpatients: (i) within 12 weeks of disease (stroke/TBI) onset, and (ii) within 2 weeks of rehabilitation ward admission 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. Exclusion Criteria: Nursing home or dormitory resident Non-resident status in Singapore (e.g. foreign worker, tourist, temporary visit pass) Impairments affecting understanding of questionnaires and tasks: e.g. severe deafness, severe visual impairment and severe /global aphasia, Presence of active fractures, dislocations, non-weight bearing status, burns, unhealed wounds, active skin infections/eczema and agitated behaviour or delirium Anticipated life expectancy < 1 year Presence of tracheostomy, ventilator, renal dialysis, end-organ failure Patients with disorders of consciousness. Pregnant or lactating participants For Knee Osteoarthritis patients only: Alternative diagnosis to knee OA e.g. Referred pain from hip or spine. Other forms of knee arthritis eg. Inflammatory, post traumatic Previous knee arthroplasty

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stroke<br>Both acutely admitted stroke patients undergoing rehabilitation and chronic recovered stroke outpatients will be recruited. | |
| Traumatic Brain Injury<br>Both acutely admitted TBI patients undergoing rehabilitation and chronic recovered TBI outpatients will be recruited. | |
| Breast Cancer<br>Only recovered breast cancer patients. | |
| Knee Osteoarthritis<br>For patients with chronic knee osteoarthritis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence (rates) of Frailty | Based off different outcomes determined in the study | Through study's data collection period, up to 4 years | 
| Severity of Frailty | Based on CFS - 9-point clinical assessment tool evaluating an individual's frailty status; maximum score: 9; higher score indicates increased frailty. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition Analysis (BCA) | Measured using weak electrical current passed from feet to estimate proportion of muscle, fat and water mass. | 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) | 
| Short Physical Performance Battery (SPPB) | 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. | 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) | 
| Hand Grip Strength (kg) | Measured seated with arms on a table bent to 90° using a dynamometer (mean of 3 readings will be recorded) | 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) | 
| Muscle Ultrasound imaging | Determines state of muscle health of arm, thigh and jaw muscles through size, area and structural properties. | For Inpatient: Visit 1 (within 2 weeks of admission), Visit 2 (1 week pre-discharge) | 
| FRAIL Questionnaire | 5-point questionnaire; (1-2 point) indicates pre-frail, (3-5 points) indicates frail | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Multimorbidity, Osteosarcopaenia