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NCT Number: NCT06073106

Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Incidence (rates) of Frailty

    Time frame: Through study's data collection period, up to 4 years

    Based off different outcomes determined in the study

  2. Severity of Frailty

    Time frame: 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 outcomes

  1. Body Composition Analysis (BCA)

    Time frame: 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.

  2. Short Physical Performance Battery (SPPB)

    Time frame: 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.

  3. Hand Grip Strength (kg)

    Time frame: 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)

  4. Muscle Ultrasound imaging

    Time frame: 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.

  5. FRAIL Questionnaire

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Low Ai Mei Jaclyn

CONTACT

[email protected]

68894580

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Collaborators

  • Rehabilitation Research Institute of Singapore (RRIS)
  • Woodlands Health (WH)

Registry information

Official study title

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

Acronym: OPTIMA-C

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 10, 2023
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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