Personalized interventions for older adults with cardiac frailty

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

This study is testing personalized exercise and diet plans to see if they can help older adults with heart problems feel better and improve their health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 21 Years to 100 Years
• Sex: All
• Sponsor: National Heart Centre Singapore (Academic / other)
• Locations: 6 sites (Singapore and 5 other locations)
• Trial ID: NCT05946174 on ClinicalTrials.gov

What this trial studies

This study aims to develop targeted exercise and dietary interventions for older adults suffering from cardiac frailty, a condition exacerbated by cardiovascular diseases. Over five years, up to 500 participants will be randomized to receive either specialized intervention sets or usual care across various healthcare settings. The first phase focuses on implementing these interventions in inpatient and outpatient environments, while the second phase will scale up successful programs. The interventions will address both exercise training and nutritional needs specific to cardiac conditions.

Who should consider this trial

Good fit: Ideal candidates for this study are older adults aged 21 and above who are ambulant and diagnosed with cardiac frailty.

Not a fit: Patients who are bed-bound, have severe cognitive impairments, or are suffering from advanced chronic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the health and quality of life for older adults with cardiac frailty by providing tailored interventions.

How similar studies have performed: Other studies have shown promise in using tailored interventions for frailty, but this specific approach targeting cardiac frailty is relatively novel.

Eligibility criteria

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

Where this trial is running

Singapore and 5 other locations

• 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)

Study contacts

• Principal investigator: Angela Su-Mei Koh, MBBS, MPH — National Heart Centre Singapore
• Study coordinator: Angela Su-Mei Koh

Conditions Cardiovascular Diseases; Frailty; Intervention; Cardiac Frailty Interventions