Precision Stratification for Frailty and Cognitive Decline

Not Applicable

Recruiting

• Conditions: Frailty; Cognitive Decline

• Registration Number: NCT07081282
• Lead Sponsor: National University of Singapore

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-06-06
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted QC: 2025-07-15
• Last Update Submitted: 2025-07-15
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23
• Primary Completion: 2027-01-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Frailty Status: - Edmonton Frailty Scale - Clinical Frailty Scale - Oral Frailty Index-8	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	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)	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)	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	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.

Secondary Outcome Measures

Name	Time	Method
Physical Activity Level - Global Physical Activity Questionnaire (GPAQ)	From enrollment to the end of treatment at 12 weeks.	The GPAQ measures physical activity in Metabolic Equivalent of Task (MET) minutes per week, with 0 MET-minutes/week as the minimum (no activity) and no theoretical upper limit. The Global Physical Activity Questionnaire (GPAQ) does not have a fixed minimum or maximum score, the higher the GPAQ score, the greater the level of physical activity.
Intrinsic Capacity - World Health Organization (WHO) Integrated Care for Older People (ICOPE) tool	From enrollment to the end of treatment at 12 weeks.	The WHO ICOPE tool comprise nine domains test on cognitive decline, limited mobility, malnutrition, visual impairment, hearing loss, depressive symptoms, social care and support, carer support and urinary incontinence. Any failure or no to each domain will lead to a suggested pathway as per WHO. There is no fixed minimum or maximum scores, the lower the number of flagged areas, the better the intrinsic capacity.
Self-Care Ability - Self-Care of Chronic Illness Inventory (SCCII)	From enrollment to the end of treatment at 12 weeks.	A generic measure designed to assess the process of self-care used by individuals with a variety of chronic conditions. It consists of 30 items that can be rated using 5-point Likert scale. There are four subdomains including self-help behavior, symptom management, health seeking behavior and self-care confidence. The minimum score is 28 and maximum score is 150. The higher the score, the better the self-care abilities.
Physical Function - Short Physical Performance Battery (SPPB)	From enrollment to the end of treatment at 12 weeks.	The SPPB is a standardised tool designed to assess lower limb function and overall physical performance in older adults. It has a minimum score of 0 and a maximum score of 12, with higher scores indicating better lower extremity function and physical performance.

Trial Locations

Locations (1)

Active Ageing Centres Under Changi General Hospital's Community Health Team Cluster (East Region); 🇸🇬 Singapore, Singapore