Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention

Recruiting

• Conditions: Traumatic Brain Injury; Breast Cancer; Stroke; Knee Osteoarthritis

• Registration Number: NCT06073106
• Lead Sponsor: Tan Tock Seng Hospital

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.

Study Timeline

• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-10
• Study Start: 2025-01-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence (rates) of Frailty	Through study's data collection period, up to 4 years	Based off different outcomes determined in the study
Severity of Frailty	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 Outcome Measures

Name	Time	Method
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)	Measured seated with arms on a table bent to 90° using a dynamometer (mean of 3 readings will be recorded)
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)	Measured using weak electrical current passed from feet to estimate proportion of muscle, fat and water mass.
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)	Measures 3 components: (1) 5 times chair stand test; (2) Balance test; (3) Gait speed (4m walk test). Score from 0-12 with higher score indicating greater functional capacity.
Muscle Ultrasound imaging	For Inpatient: Visit 1 (within 2 weeks of admission), Visit 2 (1 week pre-discharge)	Determines state of muscle health of arm, thigh and jaw muscles through size, area and structural properties.
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)	5-point questionnaire; (1-2 point) indicates pre-frail, (3-5 points) indicates frail

Trial Locations

Locations (1)

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore