Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention

Breast Cancer Clinical Trial

— OPTIMA-C  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06073106
• Other study ID #: DSRB 2023/00105
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: January 2027

Study information

• Verified date: October 2023
• Source: Tan Tock Seng Hospital
• Contact: Low Ai Mei Jaclyn
• Phone: 68894580
• Email: Jaclyn_AM_LOW[@]ttsh.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Breast Cancer
• Frailty
• Knee Osteoarthritis
• Stroke
• Traumatic Brain Injury

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital	Rehabilitation Research Institute of Singapore (RRIS), Woodlands Health (WH)

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence (rates) of Frailty	Based off different outcomes determined in the study	Through study's data collection period, up to 4 years
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)