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Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention (OPTIMA-C)

T

Tan Tock Seng Hospital

Status

Enrolling

Conditions

Breast Cancer
Traumatic Brain Injury
Stroke
Knee Osteoarthritis

Study type

Observational

Funder types

Other

Identifiers

NCT06073106
DSRB 2023/00105

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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 design

500 participants in 4 patient groups

Stroke
Description:
Both acutely admitted stroke patients undergoing rehabilitation and chronic recovered stroke outpatients will be recruited.
Traumatic Brain Injury
Description:
Both acutely admitted TBI patients undergoing rehabilitation and chronic recovered TBI outpatients will be recruited.
Breast Cancer
Description:
Only recovered breast cancer patients.
Knee Osteoarthritis
Description:
For patients with chronic knee osteoarthritis.

Trial contacts and locations

1

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Central trial contact

Low Ai Mei Jaclyn

Data sourced from clinicaltrials.gov

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