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Clinical Trials in Singapore / NCT05946174
Recruiting Not applicable

Tackling Disruptions to Frailty Interventions: Developing Personalized Interventions Targeted for Older Persons With Cardiac Frailty

NCT05946174 · tracked via the Priya Life Science Singapore tracker
Phase
Not applicable
Started
2023-07-12
Last updated
2025-06-05

Condition(s) studied

Cardiovascular Diseases

Investigational drug(s) / intervention(s)

Intervention Set AIntervention Set BIntervention Set C

Intervention Set A: exercise sessions and meals over approximately 12 weeks

Intervention Set B: exercise sessions and meals over approximately 3 weeks

Intervention Set C: meals over approximately 3 weeks

Study summary

Background: Muscle mass loss and metabolic dysfunction, exacerbated by inactivity and nutritional inadequacies, underpin both cardiovascular disease and frailty in ageing. The investigators' proposal seeks to develop interventions in exercise and diet that are targeted for older adults with cardiac frailty.

Methods:

The investigators' proposal is a five-year study comprising of first phase (first 2-2.5 years) and second phase (next 2-2.5 years). In the first phase cardiac frail participants (up to N=500) from each healthcare transition (inpatient hospital, step-down community hospital, outpatient clinic/community) will be randomized to receive Intervention Sets or usual care. The second phase will scale up these programs. Three Intervention Sets A, B, and C will be implemented in the outpatient, step-down community hospital, and acute hospital settings. Diet intervention comprises meal sets prepared with nutrients involved in energy metabolism. Exercise training is facilitated by hospital gyms and hospital physiotherapists. Diet and exercise behavior will be monitored using questionnaires, video conferencing and meal photos.

Significance: Clinical studies are urgently needed using consistent frailty tools to evaluate the efficacy and promise of frailty interventions, targeted to achieve reversal/retardation of frailty. When scaled up, these approaches will provide high-quality science needed to manage cardiac frailty towards healthier population ageing.

Eligibility

Sex
ALL
Min age
21 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 21 years old * Outdoor ambulant Exclusion Criteria: 1. Bed-bound 2. Dementia (Stage 6 onwards) 3. Residing in sheltered or nursing home 4. Cancer (to avoid confounding with cardiac disease sequelae from cancer) 5. Participation in ongoing clinical trials that involve interventional drugs or devices 6. Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥90mmHg) despite being on treatment for hypertension 7. Low blood pressure (systolic blood pressure \<90mmHg or diastolic blood pressure \<40mmHg) 8. Uncontrolled atrial fibrillation (controlled atrial fibrillation is allowed) 9. Ventricular arrhythmias (such as ventricular tachycardia) 10. Renal failure on dialysis 11. Chronic kidney disease Stage 4 and above 12. Nephrotic syndrome 13. Liver cirrhosis Child's B and above 14. Inflammatory Bowel Disease 15. Severe uncontrolled gout 16. Poorly controlled Diabetes Hba1c ≥9% 17. On warfarin 18. Presence of food allergies (such as shell-fish, prawn) 19. Patient's life expectancy is expected to be less than one year at the time of potential enrolment as assessed by the investigator 20. Nasogastric or parenteral nutrition 21. Hypertrophic cardiomyopathy 22. Cardiac amyloidosis 23. Cardiac sarcoidosis

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Alexandra Hospital Singapore Singapore Recruiting
National Heart Centre Singapore Singapore Singapore Recruiting
Changi General Hospital Singapore Singapore Recruiting
Sengkang General Hospital Singapore Singapore Recruiting
Jurong Community Hospital Singapore Singapore Recruiting
NHG Polyclinics Singapore Singapore Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05946174 on ClinicalTrials.gov ↗ ← All trials in Singapore