Cardiovascular Diseases
Conditions
Keywords
Frailty, Intervention, Cardiac Frailty Interventions
Brief 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.
Detailed description
BACKGROUND Cardiovascular disease is a formidable disruptor of interventions related to exercise intervention. Patients and physicians face uncertainty about dispensing safe and effective exercise programs to frail patients with concomitant cardiovascular disease. This hesitancy permeates across transitions from acute to step-down care to community settings. Uncertainties include fear of exacerbating heart conditions, individual variability in exercise response and what exercise targets to reach that is rational for each patient. Often, little or no exercise intervention is applied in the acute to step-down phases, which are the periods most critical for frailty reversal. Current dietary interventions do not address the special nutritional needs of acute cardiovascular conditions like heart failure, and may paradoxically induce a syndrome of cardiac cachexia that contributes to the downward spiral of frailty. STUDY DESIGN: This will be a prospective randomized clinical trial. 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. At enrolment, pre-defined study time points and end of study, participants will undergo assessments of clinical status, frailty status, cardiovascular function, nutrition, quality of life (QOL), diet/exercise behaviour, and biospecimen sampling. Three Intervention Sets 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. During the trial, exercise intervention is performed in hospitals and community hospitals by physiotherapists. Associated factors such as dietary, comorbidities and other related habits will be tracked simultaneously during the trial Intervention Set A: exercise sessions and meals over approximately 12 weeks. Intervention Set B : exercise sessions and meals over approximately 3 weeks. Intervention Set C: meals over approximately 3 weeks. PROCEDURES 1. Baseline Procedures i. Cardiovascular measurements * Non-invasive brachial blood pressure machine * Echocardiography * Electrocardiography ii. Biospecimen collection iii. Six-minute walk test iv. Musculoskeletal Analysis v. Cardiopulmonary exercise test (CPET)/ Treadmill vi. Questionnaires vii. Timed up and go (TUG) test 2. Post-intervention procedures i. Cardiovascular measurements * Non-invasive brachial blood pressure machine * Echocardiography * Electrocardiography ii. Biospecimen collection iii. Six-minute walk test iv. Musculoskeletal Analysis v. Questionnaires vi. Timed up and go (TUG) test 3. Closing questionnaires
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
Sponsors
National Heart Centre Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Set A comprises of outpatient clinic/ community participants, who will be randomized in a 1:1 ratio into Group A1 (receiving Intervention Set A- exercise sessions and meals over approximately 12 weeks) or Group A2 (control/ usual care) Set B comprises of step-down community hospital participants, who will be randomized in a 1:1 ratio into Group B1 (receiving Intervention Set B- exercise sessions and meals over approximately 3 weeks) or Group B2 (control/ usual care) Set C comprises of acute community hospital participants, who will be randomized in a 1:1 ratio into Group C1 (receiving Intervention Set C- meals over approximately 3 weeks) or Group C2 (control/ usual care)
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in skeletal muscle | at 14 weeks from baseline | Change in skeletal muscle mass (grams) |
| Improvement in cardiovascular markers | at 14 weeks from baseline | * 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 Fried Frailty Phenotype Score (improvement in any domain) (i.e., reduction in score) | at six months from baseline | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Quality of life (QOL): EuroQOL-5D-5L (higher score) | Three months and six months from baseline | A unit increase (i.e., improvement) in QOL score |
| Improvement in metabolite level | Three months and six months from baseline | Any change in metabolite (microM) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who experience a major adverse cardiovascular events | Thirty-six (36) months from baseline | 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 | Thirty-six (36) months from baseline | — |
Countries
Singapore
Contacts
Primary ContactAngela Su-Mei Koh
Backup ContactGina Sihui Lee
Outcome results
None listed