StrokeOPTIMA-CNCT06073106
Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention
An observational study of Stroke and Traumatic Brain Injury, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke, Traumatic Brain Injury, Knee Osteoarthritis
- How many people
- 500 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jan 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in both outpatient and inpatient clinics
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Low Ai Mei Jaclyn, Jaclyn_AM_LOW@ttsh.com.sg
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Traumatic Brain Injury, Knee Osteoarthritis, Breast Cancer
- Keywords
- Frailty, Multimorbidity, Osteosarcopaenia
- Medical subject headings
- Stroke, Brain Injuries, Traumatic, Osteoarthritis, Knee, Breast Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Incidence (rates) of Frailty
Based off different outcomes determined in the study
Measured: 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.
Measured: 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)
Measured using weak electrical current passed from feet to estimate proportion of muscle, fat and water mass.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Jan 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rehabilitation Research Institute of Singapore (RRIS), Woodlands Health (WH)
- Responsible party
- Sponsor
- Investigators
- Karen Chua, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073106
- Sponsor's protocol ID
- DSRB 2023/00105
- Acronym
- OPTIMA-C
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40409965
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention Through Identification and Deep Phenotyping Methods in Healthy Aging and High-burden Disease Cohorts.
- ClinicalTrials.gov ID
- NCT06073106
- Acronym / sponsor ID
- OPTIMA-C / DSRB 2023/00105
- Conditions
- Stroke, Traumatic Brain Injury, Knee Osteoarthritis, Breast Cancer
- Keywords
- Frailty, Multimorbidity, Osteosarcopaenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Rehabilitation Research Institute of Singapore (RRIS), Woodlands Health (WH)
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in both outpatient and inpatient clinics
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence (rates) of Frailty
Time frame: Through study's data collection period, up to 4 years
Based off different outcomes determined in the study
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.
5 secondary outcomes
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)
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)
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)
Muscle Ultrasound imaging
Time frame: For Inpatient: Visit 1 (within 2 weeks of admission), Visit 2 (1 week pre-discharge)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 40409965Tay 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Chua principal investigator
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Traumatic Brain Injury, run by Tan Tock Seng Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Low Ai Mei Jaclyn (68894580, Jaclyn_AM_LOW@ttsh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (rates) of Frailty (time frame: Through study's data collection period, up to 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06073106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.