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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Low Ai Mei Jaclyn; Phone Number: 68894580; Email: Jaclyn_AM_LOW@ttsh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 308433
    • Recruiting
    • Tan Tock Seng Hospital
    • Contact: Low Ai Mei Jaclyn; Email: Jaclyn_AM_LOW@ttsh.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in both outpatient and inpatient clinics

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence (rates) of Frailty	Based off different outcomes determined in the study	Through study's data collection period, up to 4 years
Severity of Frailty	Based on CFS - 9-point clinical assessment tool evaluating an individual's frailty status; maximum score: 9; higher score indicates increased 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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Composition Analysis (BCA)	Measured using weak electrical current passed from feet to estimate proportion of muscle, fat and water mass.	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)	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.	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)
Hand Grip Strength (kg)	Measured seated with arms on a table bent to 90° using a dynamometer (mean of 3 readings will be recorded)	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	Determines state of muscle health of arm, thigh and jaw muscles through size, area and structural properties.	For Inpatient: Visit 1 (within 2 weeks of admission), Visit 2 (1 week pre-discharge)
FRAIL Questionnaire	5-point questionnaire; (1-2 point) indicates pre-frail, (3-5 points) indicates frail	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)

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital
• Collaborators: Rehabilitation Research Institute of Singapore (RRIS); Woodlands Health (WH)
• Investigators: Principal Investigator: Karen Chua, Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Frailty; Multimorbidity; Osteosarcopaenia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries, Traumatic; Frailty; Brain Injuries
• Other Study ID Numbers: DSRB 2023/00105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No