Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention

NCT06073106 | Recruiting

• 1 other identifier: DSRB 2023/00105
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Traumatic Brain Injury; Knee Osteoarthritis; Breast Cancer

Keywords

Frailty; Multimorbidity; Osteosarcopaenia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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)

• 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)

• 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 Arms (4)

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in both outpatient and inpatient clinics

You may qualify if:

• Age ≥ 50y
• 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.

You may not qualify if:

• 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.
• Other forms of knee arthritis eg. Inflammatory, post traumatic
• Previous knee arthroplasty

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Rehabilitation Research Institute of Singapore (RRIS): collaborator
• Woodlands Health (WH): collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore, 308433, Singapore

RECRUITING

Related Publications (1)

• Tay MRJ, Kim JM, Ong PL, Khin LW, Wong CJ, Kong KH, Tan BY, Lee ES, Sim SZ, Lim WS, Yam MGJ, Chew JL, Tan AWK, Sidarta A, Yee E, Chua KSG. Targeting osteosarcopenia and multimorbidity for frailty prevention through identification and deep phenotyping methods in healthy ageing and high-burden disease cohorts (OPTIMA-C): a longitudinal observational cohort study protocol for neuromusculoskeletal muscle health. BMJ Open. 2025 May 23;15(5):e094279. doi: 10.1136/bmjopen-2024-094279.

  PMID: 40409965 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood samples will be collected (50ml; about 10 teaspoons) for lab assay to assess metabolic health and inflammation

MeSH Terms

Conditions

Stroke; Brain Injuries, Traumatic; Osteoarthritis, Knee; Breast Neoplasms; Frailty

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Chua

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Low Ai Mei Jaclyn

CONTACT

68894580; Jaclyn_AM_LOW@ttsh.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 10, 2023
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)