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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-100
SponsorNational Heart Centre Singapore

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Intervention Set A

    Other intervention

    exercise sessions and meals over approximately 12 weeks

  • Intervention Set B

    Other intervention

    exercise sessions and meals over approximately 3 weeks

  • Intervention Set C

    Other intervention

    meals over approximately 3 weeks

Treatment groups

500 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Outpatient clinic/community participants receiving exercise sessions and meals (A1)Experimental treatment 1 intervention
Group B: Outpatient clinic/community participants receiving control/usual care (A2)No intervention 0 interventions
Group C: Step-down community hospital participants receiving exercise sessions and meals (B1)Experimental treatment 1 intervention
Group D: Step-down community hospital participants receiving control/usual care (B2)No intervention 0 interventions
Group E: Acute hospital participants receiving meals (C1)Experimental treatment 1 intervention
Group F: Acute hospital participants receiving control/usual care (C2)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
at 14 weeks from baseline
2

Improvement in skeletal muscle

Change in skeletal muscle mass (grams)

Time frame
at 14 weeks from baseline
3

Improvement in Fried Frailty Phenotype Score (improvement in any domain) (i.e., reduction in score)

Time frame
at six months from baseline

Secondary outcomes

1

Improvement in metabolite level

Any change in metabolite (microM)

Time frame
Three months and six months from baseline
2

Improvement in Quality of life (QOL): EuroQOL-5D-5L (higher score)

A unit increase (i.e., improvement) in QOL score

Time frame
Three months and six months from baseline

Other outcomes

1

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

Time frame
Thirty-six (36) months from baseline
2

Other events include proportion of participants who experience : death, falls, fractures, hospitalization for any cause, admission into nursing home

Time frame
Thirty-six (36) months from baseline

Sponsors and contacts

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