Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	50 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age ≥ 50y. 2. Asian ethnicity. 3. First diagnosis (stroke, Traumatic Brain Injury (TBI), knee osteoarthritis, breast cancer) 4. Living in community. 5. Able to understand 1 step simple commands. 6. For inpatients: (i) within 12 weeks of disease (stroke/TBI) onset, and (ii) within 2 weeks of rehabilitation ward admission. 7. 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:

1. Nursing home or dormitory resident. 2. Non-resident status in Singapore (e.g. foreign worker, tourist, temporary visit pass) 3. Impairments affecting understanding of questionnaires and tasks: e.g. severe deafness, severe visual impairment and severe /global aphasia, 4. Presence of active fractures, dislocations, non-weight bearing status, burns, unhealed wounds, active skin infections/eczema and agitated behaviour or delirium. 5. Anticipated life expectancy < 1 year. 6. Presence of tracheostomy, ventilator, renal dialysis, end-organ failure. 7. Patients with disorders of consciousness. 8. Pregnant or lactating participants. For Knee Osteoarthritis patients only: 9. Alternative diagnosis to knee OA e.g. Referred pain from hip or spine. 10. Other forms of knee arthritis eg. Inflammatory, post traumatic. 11. Previous knee arthroplasty

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06073106
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Tan Tock Seng Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Karen Chua
Principal Investigator Affiliation	Tan Tock Seng Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Singapore
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Stroke, Traumatic Brain Injury, Knee Osteoarthritis, Breast Cancer

Additional Details

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.

Arms & Interventions

Arms

: Stroke

Both acutely admitted stroke patients undergoing rehabilitation and chronic recovered stroke outpatients will be recruited.

: Traumatic Brain Injury

Both acutely admitted TBI patients undergoing rehabilitation and chronic recovered TBI outpatients will be recruited.

: Breast Cancer

Only recovered breast cancer patients.

: Knee Osteoarthritis

For patients with chronic knee osteoarthritis.

Interventions

Contact a Trial Team

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International Sites

Tan Tock Seng Hospital, Singapore, Singapore

Status

Address

Tan Tock Seng Hospital

Singapore, , 308433

Site Contact

[email protected]

68894580

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