Tackling Disruptions to Frailty Interventions: Developing Personalized Interventions Targeted for Older Persons With Cardiac Frailty
Recruiting now · Not applicable
Conditions studied: Cardiovascular Diseases
In brief
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.
Key facts
- Study ID
- NCT05946174
- Run by
- National Heart Centre Singapore
- People needed
- 500
- Starts
- 2023-07-12
- Expected to finish
- 2028-06-21
- Last updated by the study team
- 2025-06-05
Who can join
Age: 21 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 21 years old
- Outdoor ambulant
You may not qualify if…
- Bed-bound
- Dementia (Stage 6 onwards)
- Residing in sheltered or nursing home
- Cancer (to avoid confounding with cardiac disease sequelae from cancer)
- Participation in ongoing clinical trials that involve interventional drugs or devices
- Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥90mmHg) despite being on treatment for hypertension
- Low blood pressure (systolic blood pressure <90mmHg or diastolic blood pressure <40mmHg)
- Uncontrolled atrial fibrillation (controlled atrial fibrillation is allowed)
- Ventricular arrhythmias (such as ventricular tachycardia)
- Renal failure on dialysis
- Chronic kidney disease Stage 4 and above
- Nephrotic syndrome
- Liver cirrhosis Child's B and above
- Inflammatory Bowel Disease
- Severe uncontrolled gout
- Poorly controlled Diabetes Hba1c ≥9%
- On warfarin
- Presence of food allergies (such as shell-fish, prawn)
- Patient's life expectancy is expected to be less than one year at the time of potential enrolment as assessed by the investigator
- Nasogastric or parenteral nutrition
- Hypertrophic cardiomyopathy
- Cardiac amyloidosis
- Cardiac sarcoidosis
Where it is running
- Alexandra Hospital — Singapore, Singapore (enrolling)
- National Heart Centre Singapore — Singapore, Singapore (enrolling)
- Changi General Hospital — Singapore, Singapore (enrolling)
- Sengkang General Hospital — Singapore, Singapore (enrolling)
- Jurong Community Hospital — Singapore, Singapore (enrolling)
- NHG Polyclinics — Singapore, Singapore (enrolling)
Full record on ClinicalTrials.gov
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