FrailtyNCT07081282
Precision Stratification for Frailty and Cognitive Decline
A study testing Care4Senior mobile Application, Intensive Aerobic Resistance Training and Brain Health (CIRTAB) and Centre-Based Exercise Health Session in people with Frailty and Cognitive Decline, run by National University of Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Frailty, Cognitive Decline
- What is being tested?
- Care4Senior mobile Application, Intensive Aerobic Resistance Training and Brain Health (CIRTAB) and Centre-Based Exercise Health Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jul 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Delphine Ms Chen contact
Singapore1 site, 1 recruiting
- Recruiting
Active Ageing Centres Under Changi General Hospital's Community Health Team Cluster (East Region)
Singapore
Michelle Ms Kee, +6569365827, michelle.kee.m.n@singhealth.com.sg
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Frailty, Cognitive Decline
- Being tested
- Care4Senior mobile Application, Intensive Aerobic Resistance Training and Brain Health (CIRTAB), Centre-Based Exercise Health Session
- Medical subject headings
- Frailty, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care4Senior mobile Application, Intensive Aerobic Resistance Training and Brain Health (CIRTAB)Behavioural
Also called CIRTAB
Care4Senior mobile Application, Intensive Aerobic Resistance Training and Brain Health (CIRTAB)
Centre-Based Exercise Health SessionBehavioural
Participants will receive one time centre-based exercise health programme each week.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants will receive the CIRTAB intervention three times each week over 12-weeks. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks.
Secondary outcomes (4)
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.
Measured: From enrollment to the end of treatment at 12 weeks.
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.
Measured: From enrollment to the end of treatment at 12 weeks.
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.
Measured: From enrollment to the end of treatment at 12 weeks.
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.
Measured: From enrollment to the end of treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Jul 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Changi General Hospital
- Responsible party
- Principal investigator, Vivien Xi WU, PhD, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081282
- Sponsor's protocol ID
- NUS-IRB-2023-526
- Status last verified
- Jul 2025
- First submitted
- 6 Jun 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07081282
- Acronym / sponsor ID
- NUS-IRB-2023-526
- Conditions
- Frailty, Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Changi General Hospital
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Care4Senior mobile Application, Intensive Aerobic Resistance Training and Brain Health (CIRTAB)Participants will receive the CIRTAB intervention three times each week over 12-weeks. |
| Active Control | Active comparator | Behavioral: Centre-Based Exercise Health SessionParticipants will receive once in centre-based exercise health programme each week over 12-weeks. |
| Control | No intervention | –Participants will not participate in any exercise-related or brain health-related research studies or centre-based programme during trial period. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care4Senior mobile Application, Intensive Aerobic Resistance Training and Brain Health (CIRTAB)Also: CIRTABCare4Senior mobile Application, Intensive Aerobic Resistance Training and Brain Health (CIRTAB) | Behavioural | Intervention Arm |
| Centre-Based Exercise Health SessionParticipants will receive one time centre-based exercise health programme each week. | Behavioural | Active Control |
Primary outcome
Frailty Status: - Edmonton Frailty Scale - Clinical Frailty Scale - Oral Frailty Index-8
Time frame: 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
Time frame: 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.
Presence of Cognitive Decline: - Montreal Cognitive Assessment - Symbol Digit Modalities Test - Cognitive Predictive Risk Score (developed from previous study)
Time frame: 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.
Immunological Biomarkers: - C1q (complement component 1q) - IL-6 (Interleukin-6)
Time frame: 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.
Skeletomuscular Biomarkers: - IGF-1 (Insulin-like Growth Factor-1) - Myostatin
Time frame: 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.
4 secondary outcomes
Self-Care Ability - Self-Care of Chronic Illness Inventory (SCCII)
Time frame: From enrollment to the end of treatment at 12 weeks.
Physical Activity Level - Global Physical Activity Questionnaire (GPAQ)
Time frame: From enrollment to the end of treatment at 12 weeks.
Physical Function - Short Physical Performance Battery (SPPB)
Time frame: From enrollment to the end of treatment at 12 weeks.
Intrinsic Capacity - World Health Organization (WHO) Integrated Care for Older People (ICOPE) tool
Time frame: From enrollment to the end of treatment at 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Delphine Ms Chen contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care4Senior mobile Application, Intensive Aerobic Resistance Training and Brain Health (CIRTAB) and Centre-Based Exercise Health Session in people with Frailty and Cognitive Decline, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vivien Dr Wu (+6566012756, vivien.wu@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty Status: - Edmonton Frailty Scale - Clinical Frailty Scale - Oral Frailty Index-8 (time frame: From enrollment to the end of treatment at 12 weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.