Clinical trial NCT06073106: Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention
Official title: Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention Through Identification and Deep Phenotyping Methods in Healthy Aging and High-burden Disease Cohorts.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Traumatic Brain Injury
Knee Osteoarthritis
Breast Cancer
Keywords: Frailty
Multimorbidity
Osteosarcopaenia
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
Collaborators: name: Rehabilitation Research Institute of Singapore (RRIS)
name: Woodlands Health (WH)
First posted: 2023-10-10
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in both outpatient and inpatient clinics

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.

Eligibility 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

Primary outcomes:
measure: Incidence (rates) of Frailty
timeFrame: Through study's data collection period, up to 4 years
measure: Severity of Frailty
timeFrame: 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)
Secondary outcomes:
measure: Body Composition Analysis (BCA)
timeFrame: 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)
measure: Short Physical Performance Battery (SPPB)
timeFrame: 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)
measure: Hand Grip Strength (kg)
timeFrame: 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)
measure: Muscle Ultrasound imaging
timeFrame: For Inpatient: Visit 1 (within 2 weeks of admission), Visit 2 (1 week pre-discharge)
measure: FRAIL Questionnaire
timeFrame: 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)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Karen Chua
role: PRINCIPAL_INVESTIGATOR
References: