ongoing

DEFINIT-P is a pilot study that will determine the feasibility of a larger, multi-centre randomized clinical trial to evaluate the efficacy of a supervised exercise and nutritional supplement program in preventing or reversing frailty in cardiac device recipients.

The primary outcomes in this pilot will be:

1) the rate of identification of eligible patients
2) the proportion of eligible patients consenting to participate, and randomized
3) the rate of adherence to the trial interventions
(as measured by supervised exercise attendance rates, device-recorded physical activity levels, and direct question about nutritional supplement/placebo adherence)
4) the obstacles to and facilitators of adherence to the intervention

The secondary outcomes in this pilot will be:

1) frailty, as measured by the Fried index
2) clinical cardiovascular outcomes
(myocardial infarction, stroke, heart failure hospitalization, atrial fibrillation, ventricular tachyarrhythmia)
3) cardiac device complications (inappropriate defibrillator shocks, lead dislodgement)
4) injury from a fall or fracture.

Study Type

Interventional - Procedure

Study Design

Multi-centre RCT pilot

NO. of Countries

1

NO. of Sites

1

NO. of Participants

120

Study Period

2019-2020

Sponsor

PHRI

PHRI Internal Grant Competition

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