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DEFINI-P

Official Title

Diet and Exercise Frailty INTervention in Cardiac Device Patients – Trial Pilot

Status

Ongoing

Overview

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.

Study Design

Those who are pre-frail or frail will be invited to participate in the pilot randomized, controlled trial of the 12-month exercise and dietary supplement intervention

Primary Endpoint

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

Number of Patients

20

Number of Sites

1

Number of Countries

1

Study Period

2019-2020

Principal Investigator

Darryl Leong, Jeff Healey, Jackie Bosch, Mark Tarnopolsky

Program Manager

Jessica Tyrwhitt

Research Coordinator

Sarah Karampatos