Tackling Disruptions to Frailty Interventions: Developing Personalized Interventions Targeted for Older Persons With Cardiac Frailty
- Conditions
- Cardiovascular Diseases
- Interventions
- Other: Intervention Set AOther: Intervention Set BOther: Intervention Set C
- Registration Number
- NCT05946174
- Lead Sponsor
- National Heart Centre Singapore
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Age ≥ 21 years old
- Outdoor ambulant
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Outpatient clinic/community participants receiving exercise sessions and meals (A1) Intervention Set A Outpatient clinic/community participants receiving intervention Set A (exercise sessions and meals over approximately 12 weeks) Step-down community hospital participants receiving exercise sessions and meals (B1) Intervention Set B Step-down community hospital participants receiving Intervention Set B (exercise sessions and meals over approximately 3 weeks) Acute hospital participants receiving meals (C1) Intervention Set C Acute hospital participants receiving Intervention Set C (meals over approximately 3 weeks)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Improvement in metabolite level Three months and six months from baseline Any change in metabolite (microM)
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
Trial Locations
- Locations (6)
Changi General Hospital
🇸🇬Singapore, Singapore
Alexandra Hospital
🇸🇬Singapore, Singapore
Sengkang General Hospital
🇸🇬Singapore, Singapore
NHG Polyclinics
🇸🇬Singapore, Singapore
Jurong Community Hospital
🇸🇬Singapore, Singapore
National Heart Centre Singapore
🇸🇬Singapore, Singapore