Diet and Exercise Frailty Intervention in Cardiac Device Patients (DEFINIT-P)

Diet and Exercise Frailty Intervention in Cardiac Device Patients Trial Pilot

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardiovascular Diseases; Frailty
• Intervention / Treatment: Other: Exercise and Nutritional Supplement

Detailed Description

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
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Randomized Intervention; 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; 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).
No Intervention: Randomized - Control; 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?

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

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Investigators: Principal Investigator: Darryl Leong, PhD. MBBSm, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 12, 2019

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise; Quality of Life; Physical Function; Biomarkers; Nutritional Supplement; Defibrillators; Pacemakers; Cardiac Device
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Frailty
• Other Study ID Numbers: DEFINIT_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No