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Trial Title:
Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention
NCT ID:
NCT06073106
Condition:
Stroke
Traumatic Brain Injury
Knee Osteoarthritis
Breast Cancer
Conditions: Official terms:
Brain Injuries
Brain Injuries, Traumatic
Frailty
Conditions: Keywords:
Frailty
Multimorbidity
Osteosarcopaenia
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Patients in both outpatient and inpatient clinics
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
50 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tan Tock Seng Hospital
Address:
City:
Singapore
Zip:
308433
Country:
Singapore
Start date:
December 2023
Completion date:
January 2027
Lead sponsor:
Agency:
Tan Tock Seng Hospital
Agency class:
Other
Collaborator:
Agency:
Rehabilitation Research Institute of Singapore (RRIS)
Agency class:
Other
Collaborator:
Agency:
Woodlands Health (WH)
Agency class:
Other
Source:
Tan Tock Seng Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06073106
