Precision Stratification for Frailty and Cognitive Decline

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorNational University of Singapore

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Care4Senior mobile Application, Intensive Aerobic Resistance Training and Brain Health (CIRTAB)

    Behavioral

    Care4Senior mobile Application, Intensive Aerobic Resistance Training and Brain Health (CIRTAB)

  • Centre-Based Exercise Health Session

    Behavioral

    Participants will receive one time centre-based exercise health programme each week.

Treatment groups

252 Participants
are divided into 3 treatment groups
Group A: Intervention ArmExperimental treatment 1 intervention
Group B: Active ControlActive comparator 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
From enrollment to the end of treatment at 12 weeks.
2

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

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.

Time frame
From enrollment to the end of treatment at 12 weeks.
3

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

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.

Time frame
From enrollment to the end of treatment at 12 weeks.
4

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

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.

Time frame
From enrollment to the end of treatment at 12 weeks.

Secondary outcomes

1

Self-Care Ability - Self-Care of Chronic Illness Inventory (SCCII)

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.

Time frame
From enrollment to the end of treatment at 12 weeks.
2

Physical Activity Level - Global Physical Activity Questionnaire (GPAQ)

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.

Time frame
From enrollment to the end of treatment at 12 weeks.
3

Physical Function - Short Physical Performance Battery (SPPB)

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.

Time frame
From enrollment to the end of treatment at 12 weeks.
4

Intrinsic Capacity - World Health Organization (WHO) Integrated Care for Older People (ICOPE) tool

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.

Time frame
From enrollment to the end of treatment at 12 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University of Singapore

Lead sponsor

Changi General Hospital

Collaborator