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Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06073106
Acronym
OPTIMA-C
Enrollment
500
Registered
2023-10-10
Start date
2025-01-01
Completion date
2027-01-31
Last updated
2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Knee Osteoarthritis, Stroke, Traumatic Brain Injury

Keywords

Frailty, Multimorbidity, Osteosarcopaenia

Brief summary

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

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.

Interventions

None listed

Sponsors

Rehabilitation Research Institute of Singapore (RRIS)
CollaboratorUNKNOWN
Woodlands Health (WH)
CollaboratorUNKNOWN
Tan Tock Seng Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence (rates) of FrailtyThrough study's data collection period, up to 4 yearsBased off different outcomes determined in the study
Severity of FrailtyFor 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)Based on CFS - 9-point clinical assessment tool evaluating an individual's frailty status; maximum score: 9; higher score indicates increased frailty.

Secondary

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

Countries

Singapore

Contacts

Primary ContactLow Ai Mei Jaclyn
Jaclyn_AM_LOW@ttsh.com.sg68894580

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026