Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Incidence (rates) of Frailty [Срок оценки: Through study's data collection period, up to 4 years]
• Severity of Frailty [Срок оценки: 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)]

Вторичные конечные точки (5)

• Body Composition Analysis (BCA) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: For Inpatient: Visit 1 (within 2 weeks of admission), Visit 2 (1 week pre-discharge)]
• FRAIL Questionnaire [Срок оценки: 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)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Сингапур · 1 центр

• Tan Tock Seng Hospital — Singapore

Публикации

• 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 mus PMID 40409965

Идентификаторы

NCT: NCT06073106 · DSRB 2023/00105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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