RecruitingNot ApplicableNCT05946174

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


Sponsor

National Heart Centre Singapore

Enrollment

500 participants

Start Date

Jul 12, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 21 YearsMax Age: 100 Years

Inclusion Criteria2

  • Age ≥ 21 years old
  • Outdoor ambulant

Exclusion Criteria23

  • 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

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Interventions

OTHERIntervention Set A

exercise sessions and meals over approximately 12 weeks

OTHERIntervention Set B

exercise sessions and meals over approximately 3 weeks

OTHERIntervention Set C

meals over approximately 3 weeks


Locations(6)

Alexandra Hospital

Singapore, Singapore

National Heart Centre Singapore

Singapore, Singapore

Changi General Hospital

Singapore, Singapore

Sengkang General Hospital

Singapore, Singapore

Jurong Community Hospital

Singapore, Singapore

NHG Polyclinics

Singapore, Singapore

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