Precision Stratification for Frailty and Cognitive Decline

NCT07081282 | Recruiting

• 1 other identifier: NUS-IRB-2023-526
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Cognitive Decline

Outcome Measures

Primary Outcomes (5)

• 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.

  From enrollment to the end of treatment at 12 weeks.

• 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.

  From enrollment to the end of treatment at 12 weeks.

• 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.

  From enrollment to the end of treatment at 12 weeks.

• 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.

  From enrollment to the end of treatment at 12 weeks.

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

  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.

  From enrollment to the end of treatment at 12 weeks.

Secondary Outcomes (4)

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

  From enrollment to the end of treatment at 12 weeks.

• Physical Activity Level - Global Physical Activity Questionnaire (GPAQ)

  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.

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

  From enrollment to the end of treatment at 12 weeks.

Study Arms (3)

Intervention Arm

EXPERIMENTAL

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

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

Active Control

ACTIVE COMPARATOR

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

Behavioral: Centre-Based Exercise Health Session

Control

NO INTERVENTION

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

Interventions

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

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

Also known as: CIRTAB

Intervention Arm

Centre-Based Exercise Health Session BEHAVIORAL

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

Active Control

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National University of Singapore: lead
• Changi General Hospital: collaborator

Study Sites (1)

Active Ageing Centres Under Changi General Hospital's Community Health Team Cluster (East Region)

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Frailty; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Vivien Dr Wu

CONTACT

+6566012756; vivien.wu@nus.edu.sg

Delphine Ms Chen

CONTACT

e0002650@u.nus.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: July 23, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)