跳至主要内容
临床试验/NCT07081282
NCT07081282招募中不适用

Precision Care Pathway Through Frailty and Cognitive Assessment Among Older Adults and Development of Care4Senior App, Intensive Aerobic Resistance Training and Brain Health Program in the Community

National University of Singapore1 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
252
试验地点
1
主要终点
Frailty Status: - Edmonton Frailty Scale - Clinical Frailty Scale - Oral Frailty Index-8

研究概览

简要总结

The Care4Senior mobile Application, Intensive Aerobic Resistance Training and Brain Health (CIRTAB) trial aim to test the effectiveness of an exercise, cognitive and lifestyle intervention amongst older adults over a 12-weeks trial period to prevent frailty and promote social bonding.

详细描述

In the Care4Senior mobile Application, Intensive Aerobic Resistance Training and Brain Health (CIRTAB) trial, participants will use the Care4Seniors 2.0 mobile application, in which physical and cognitive exercises will be provided to participants using this digital technology. Weekly in-person group exercise and cognitive sessions will also be conducted to prevent frailty, promote social bonding, as well as reduce social isolation and loneliness.

In the long term, this new service model has the potential to transform care, contain healthcare cost inflation and increase the efficiency of the lean manpower. It will translate knowledge into practice, resulting in impactful outcomes such as better self-management and healthy longevity. The CIRTAB program will raise the awareness of health behaviour, thus attracting more older adults to engage in preventive health and thus better prepare them for healthy ageing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Older Adults Aged 60 to 85 years old
  • •Living in the community
  • •Formally diagnosed with at least one chronic disease
  • •Able to communicate in either English or Mandarin

排除标准

  • •Severe vision or hearing impairment
  • •Diagnosed with severe cognitive impairment (e.g. dementia)
  • •Diagnosed with severe psychiatric disorders (e.g. psychotic disorders, major depressive disorder)

研究组 & 干预措施

Active Control

Active Comparator

Participants will receive once in centre-based exercise health programme each week over 12-weeks.

干预措施: Centre-Based Exercise Health Session (Behavioral)

Intervention Arm

Experimental

Participants will receive the CIRTAB intervention three times each week over 12-weeks.

干预措施: Care4Senior mobile Application, Intensive Aerobic Resistance Training and Brain Health (CIRTAB) (Behavioral)

Control

No Intervention

Participants will not participate in any exercise-related or brain health-related research studies or centre-based programme during trial period.

结局指标

主要结局

Frailty Status: - Edmonton Frailty Scale - Clinical Frailty Scale - Oral Frailty Index-8

时间窗: From enrollment to the end of treatment at 12 weeks.

These measurements will be conducted by researchers at three timepoints - baseline, immediate post-intervention and 6 months post-intervention. The Edmonton Frailty Scale ranges from a minimum score of 0 (not frail) to a maximum score of 17 (severely frail), with higher scores indicating greater frailty. The Clinical Frailty Scale ranges from 1 (very fit) to 9 (terminally ill), with higher scores indicating greater frailty. The Oral Frailty Index-8 (OFI-8) ranges from a minimum score of 0 to a maximum of 8, with higher scores indicating greater oral frailty.

Presence of Sarcopenia: - Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) Questionnaire

时间窗: From enrollment to the end of treatment at 12 weeks.

These measurements will be conducted by researchers at three timepoints - baseline, immediate post-intervention and 6 months post-intervention. The SARC-F Questionnaire ranges from a minimum score of 0 to a maximum of 10, with higher scores indicating greater risk of sarcopenia. A score of 4 or more suggests sarcopenia.

Immunological Biomarkers: - C1q (complement component 1q) - IL-6 (Interleukin-6)

时间窗: From enrollment to the end of treatment at 12 weeks.

These measurements will be conducted by researchers at two timepoints - baseline and immediate post-intervention. The C1q levels typically range from 70 to 180 mg/L, with lower values indicating worsening immune function. The IL-6 levels normally range from 0 to 7 pg/mL, with higher values indicating increased inflammation.

Presence of Cognitive Decline: - Montreal Cognitive Assessment - Symbol Digit Modalities Test - Cognitive Predictive Risk Score (developed from previous study)

时间窗: From enrollment to the end of treatment at 12 weeks.

These measurements will be conducted by researchers at three timepoints - baseline, immediate post-intervention and 6 months post-intervention. The Montreal Cognitive Assessment (MoCA) is a screening tool for mild cognitive impairment, scored out of 30 points, with higher scores indicating better cognitive function. The Symbol Digit Modalities Test (SDMT) assesses attention, processing speed, and visual-motor coordination, typically scored by the number of correct symbol-digit matches in 90 seconds, with higher scores indicating better performance. The total score for SDMT is 110. The Cognitive Predictive Risk Score developed from previous study stratify the participants into those with high risk of cognitive decline and those with low risk of cognitive decline.

Skeletomuscular Biomarkers: - IGF-1 (Insulin-like Growth Factor-1) - Myostatin

时间窗: From enrollment to the end of treatment at 12 weeks.

These measurements will be conducted by researchers at two timepoints - baseline and immediate post-intervention. The IGF-1 levels may range from 100 to 300 ng/mL, with lower levels associated with possible growth hormone deficiency. The Myostatin levels in serum range between 1 to 5 ng/mL, with higher levels associated with reduced muscle mass.

次要结局

  • Physical Activity Level - Global Physical Activity Questionnaire (GPAQ)(From enrollment to the end of treatment at 12 weeks.)
  • Intrinsic Capacity - World Health Organization (WHO) Integrated Care for Older People (ICOPE) tool(From enrollment to the end of treatment at 12 weeks.)
  • Self-Care Ability - Self-Care of Chronic Illness Inventory (SCCII)(From enrollment to the end of treatment at 12 weeks.)
  • Physical Function - Short Physical Performance Battery (SPPB)(From enrollment to the end of treatment at 12 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vivien Xi WU, PhD

Assistant Professor

National University of Singapore

研究点 (1)

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