Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention

NCT ID: NCT06073106

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-01-31

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.

Conditions

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Stroke Traumatic Brain Injury Knee Osteoarthritis Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stroke

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

No interventions assigned to this group

Traumatic Brain Injury

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

No interventions assigned to this group

Breast Cancer

Only recovered breast cancer patients.

No interventions assigned to this group

Knee Osteoarthritis

For patients with chronic knee osteoarthritis.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rehabilitation Research Institute of Singapore (RRIS)

UNKNOWN

Sponsor Role collaborator

Woodlands Health (WH)

UNKNOWN

Sponsor Role collaborator

Tan Tock Seng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Chua

Role: PRINCIPAL_INVESTIGATOR

Tan Tock Seng Hospital

Locations

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Tan Tock Seng Hospital

Singapore, Singapore, Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Low Ai Mei Jaclyn

Role: CONTACT

Facility Contacts

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Low Ai Mei Jaclyn

Role: primary

References

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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.

Reference Type DERIVED
PMID: 40409965 (View on PubMed)

Other Identifiers

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DSRB 2023/00105

Identifier Type: -

Identifier Source: org_study_id

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