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Clinical Trials/NCT06073106
NCT06073106
Recruiting
Not Applicable

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

Tan Tock Seng Hospital1 site in 1 country500 target enrollmentJanuary 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Tan Tock Seng Hospital
Enrollment
500
Locations
1
Primary Endpoint
Incidence (rates) of Frailty
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2025
End Date
January 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Tan Tock Seng Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Incidence (rates) of Frailty

Time Frame: Through study's data collection period, up to 4 years

Based off different outcomes determined in the study

Severity of Frailty

Time Frame: 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)

Based on CFS - 9-point clinical assessment tool evaluating an individual's frailty status; maximum score: 9; higher score indicates increased frailty.

Secondary Outcomes

  • 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))
  • 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))
  • 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))
  • Muscle Ultrasound imaging(For Inpatient: Visit 1 (within 2 weeks of admission), Visit 2 (1 week pre-discharge))
  • FRAIL Questionnaire(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))

Study Sites (1)

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