Diet and Exercise Frailty Intervention in Cardiac Device Patients

Study Overview
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Brief Summary
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DEFINIT-P is a prospective pilot study of frailty in cardiac device recipients, comprised of a registry and randomized control trial. The RCT is a supervised exercise program and nutritional supplement intervention for pre-frail and frail cardiac device participants. The registry will be used to describe all cardiac device recipients, regardless of frailty status.

Detailed Description
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DEFINIT-P is a single center randomized controlled trial and registry. This pilot study will determine the feasibility of a larger, multi-center randomized clinical trial which aims to evaluate the efficacy of a supervised exercise program and nutritional supplement program in reversing or preventing progression of frailty in cardiac device recipients. The future trial would also examine the physiologic effects of exercise and nutritional supplementation to understand their effects on blood biomarker profiles, which will provide insight into potentially targetable mechanisms underlying frailty.

Official Title
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Diet and Exercise Frailty Intervention in Cardiac Device Patients Trial Pilot

Conditions
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Frailty, Cardiovascular Diseases

Intervention / Treatment
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* Other: Exercise and Nutritional Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Permanent pacemaker recipients OR Implantable cardioverter defibrillator recipients Exclusion criteria Age <55 years, or Unwilling to consent Patients will be eligible for the registry but not eligible for the randomized control trial if they fulfill any of: Are non-frail Already undertaking >1 hour per week of dedicated exercise Existing or prior referral for cardiac rehabilitation Moderate or severe heart failure (New York Heart Association class III or IV) Unstable angina Any other medical condition that will prevent exercise participation Dementia, as identified by a Mini-Mental State Examination score <25

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Randomized Intervention<br>The intervention will consist of an exercise intervention, a combination of supervised exercise classes and in home exercises and open label nutritional supplement. | Other: Exercise and Nutritional Supplement<br>* The intervention consists of exercise (a combination of supervised and in home) as well as a nutritional supplement (a combination of whey protein and creatine).<br>|
| No Intervention: Randomized - Control<br>The control will consist of a single group educational session which will include the discussion of general advice on health, exercise and nutrition as well as open label nutritional supplement | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of identification of eligible patients | The primary outcome will be the number of patients that meet eligibility criteria. | 1 year | 
| The proportion of eligible patients consenting to participate and randomized | The number of eligible patients that agree to participate in the randomized control trial and the number of eligible patients that consent to participate in the observational trial | 1 year | 
| The change in the rate of adherence to the trial interventions from baseline to 12 months | The intervention adherence of both the exercise intervention and nutritional supplement | 3 months, 6 months, 1 year | 
| Barriers and facilitators of adherence to the intervention | The identification of barriers to exercise and nutritional supplement adherence | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frailty biomarker levels | The change in frailty biomarkers (not yet determined) from baseline to 12 months | 1 year | 
| Physical activity levels as measured by the cardiac device (Permanent pacemaker or Implantable cardioverter defibrillator) | The change in the volume of physical activity as detected by device (hours per day) | 1 year | 
| Myocardial infarction, stroke, heart failure hospitalization, atrial fibrillation or ventricular tachyarrhythmia | The rate of occurrence of myocardial infarction, stroke, heart failure hospitalization, atrial fibrillation or ventricular tachyarrhythmia | 1 year | 
| Cardiac device complications | The rate of occurrence of inappropriate defibrillator shocks or lead dislodgement | 1 year | 
| Injury from a fall or fractures | The rate of occurrence of injury from a fall or fracture | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Nutritional Supplement, Physical Function, Quality of Life, Cardiac Device, Physical Activity, Defibrillators, Pacemakers, Biomarkers