About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 21 years old
Outdoor ambulant
Disqualifiers
Bed-bound
Dementia (Stage 6 onwards)
Residing in sheltered or nursing home
Cancer (to avoid confounding with cardiac disease sequelae from cancer)
Trial design
Parallel
Treatments tested in this trial
Intervention Set A
Other interventionexercise sessions and meals over approximately 12 weeks
Intervention Set B
Other interventionexercise sessions and meals over approximately 3 weeks
Intervention Set C
Other interventionmeals over approximately 3 weeks
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Improvement in cardiovascular markers
* Change in cardiovascular variables are diastolic function variables such as mitral annular velocities (m/s) OR; * Change in Aerobic capacity (V02, ml/kg/min)
Improvement in skeletal muscle
Change in skeletal muscle mass (grams)
Improvement in Fried Frailty Phenotype Score (improvement in any domain) (i.e., reduction in score)
Secondary outcomes
Improvement in metabolite level
Any change in metabolite (microM)
Improvement in Quality of life (QOL): EuroQOL-5D-5L (higher score)
A unit increase (i.e., improvement) in QOL score
Other outcomes
Proportion of participants who experience a major adverse cardiovascular events
Include cardiac mortality, acute myocardial infarction, unstable angina, any revascularization, heart failure, atrial fibrillation, strokes
Other events include proportion of participants who experience : death, falls, fractures, hospitalization for any cause, admission into nursing home
Sponsors and contacts
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