Diet and Exercise Frailty Intervention in Cardiac Device Patients

Population Health Research Institute

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Frailty Cardiovascular Diseases

Interventions

Exercise and Nutritional SupplementOTHER

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).

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria 1. Permanent pacemaker recipients OR 2. Implantable cardioverter defibrillator recipients Exclusion criteria 1. Age \<55 years, or 2. Unwilling to consent Patients will be eligible for the registry but not eligible for the randomized control trial if they fulfill any of: 1. Are non-frail 2. Already undertaking \>1 hour per week of dedicated exercise 3. Existing or prior referral for cardiac rehabilitation 4. Moderate or severe heart failure (New York Heart Association class III or IV) 5. Unstable angina 6. Any other medical condition that will prevent exercise participation 7. Dementia, as identified by a Mini-Mental State Examination score \<25

Locations (1)

Hamilton General Hospital

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Rate of identification of eligible patients

The primary outcome will be the number of patients that meet eligibility criteria.

Time frame: 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

Time frame: 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

Time frame: 3 months, 6 months, 1 year

Barriers and facilitators of adherence to the intervention

The identification of barriers to exercise and nutritional supplement adherence

Time frame: 1 year

Secondary Outcomes

Frailty biomarker levels

The change in frailty biomarkers (not yet determined) from baseline to 12 months

Time frame: 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)

Time frame: 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

Data from ClinicalTrials.gov

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