The Cardiovascular-Cognitive Health Initiative

NCT07829380 | Recruiting

• 2 other identifiers: 2025/1892NICCOG2024-0024
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 4

Brief Summary

This study aims to understand how memory and thinking abilities (cognition) are affected in patients with heart conditions, and to find out if early detection and interventions can improve health outcomes.

Conditions

Cognitive Impairment

Keywords

cognitive assessment; cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Primary RCT Outcome

  Proportion of participants demonstrating clinically meaningful improvement in cognitive function at 24 weeks, defined as a pre-specified increase in standardized cognitive test scores.

  24 weeks

Study Arms (3)

Main (Observational) Cohort

NO INTERVENTION

Required procedures during baseline visit: i. Blood pressure test ii. Biospecimen collection (Optional) iii. Musculoskeletal analysis iv. Memory test: MoCA and MMSE

Randomized Controlled Trial (RCT) R1 Cohort

OTHER

Baseline: 1. Cardiovascular measurements:- * Blood pressure test * Echocardiography * Electrocardiography 2. Biospecimen collection 3. Six-minute walk test 4. Musculoskeletal Analysis 5. Cardiopulmonary exercise test (CPET) / Treadmill test (TMX) 6. Magnetic resonance imaging 7. Neuropsychological assessment During Intervention: 12 exercise sessions and 12 cognitive sessions Post-Intervention: 1. Same procedures as Baseline except CPET / TMX 2. Post-intervention questionnaire 3. Qualitative interview (Optional)

Other: Structured cognitive and cardiovascular interventions

Randomized Controlled Trial (RCT) R2 Cohort

NO INTERVENTION

Baseline: 1. Cardiovascular measurements:- * Blood pressure test * Echocardiography * Electrocardiography 2. Biospecimen collection 3. Six-minute walk test 4. Musculoskeletal Analysis 5. Cardiopulmonary exercise test (CPET) / Treadmill test (TMX) 6. Magnetic resonance imaging 7. Neuropsychological assessment Post-Intervention: 1. Same procedures as Baseline, except CPET / TMX 2. Post-intervention questionnaire

Interventions

Structured cognitive and cardiovascular interventions OTHER

The intervention arm (RCT R1 cohort) will receive a 24-week multi-component program combining cardiac rehabilitation instruction, cognitive stimulation via a hybrid hospital and home-based telehealth platform.

Randomized Controlled Trial (RCT) R1 Cohort

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Main Study:
• Age ≥ 21 years.
• Able and willing (or via legally acceptable representative, LAR, where appropriate) to provide informed consent.
• RCT Sub-Study (Mild cognitive impairment (MCI) arm):
• Meets main study criteria.
• Mild cognitive impairment defined by: (i) Montreal cognitive assessment (MoCA) \<26 but ≥21; and/or (ii) impairment in at least one domain on standardized neuropsychological testing and/or (iii) MMSE \<28 but ≥24.

You may not qualify if:

• Neurodegenerative disorders or major psychiatric illnesses that substantially impair cognition.
• Terminal illness or advanced major organ disease limiting participation with expected survival of less than 1 year.
• Severe depression, anxiety, or stress where participation may be inappropriate.
• Any condition which, in the investigator's opinion, would compromise safety or study integrity.
• Note: Pregnant and breast-feeding women may not take part in this study.

Sponsors & Collaborators

• National Heart Centre Singapore: lead

Study Sites (4)

Alexandra Hospital

Singapore, Singapore

NOT YET RECRUITING

Khoo Teck Puat Hospital

Singapore, Singapore

NOT YET RECRUITING

National Heart Centre Singapore

Singapore, Singapore

RECRUITING

Sengkang General Hospital

Singapore, Singapore

NOT YET RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Angela S. Koh, MBBS

CONTACT

+6567048961; angela.koh.s.m@singhealth.com.sg

Mee Yin Wong, BSc

CONTACT

+6567042302; wong.mee.yin@nhcs.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: After obtaining consent, patient's study arm will be revealed via sequentially numbered, opaque, sealed and stapled envelopes.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There are both cohorts: main (observational) and randomized controlled trial (RCT) cohort. Participants in the RCT cohort will be randomized to receive exercise and cognitive intervention (Group R1) or no exercise nor cognitive intervention (Group R2).

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 21, 2026
• Study Start: August 4, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 21, 2026

Record last verified: 2026-09

Locations

SG (4)