Diet and Exercise Frailty Intervention in Cardiac Device Patients

Not Applicable

Withdrawn

• Conditions: Frailty; Cardiovascular Diseases
• Interventions: Other: Exercise and Nutritional Supplement

• Registration Number: NCT04052672
• Lead Sponsor: Population Health Research Institute

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-12
• Study Start: 2019-11-01
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomized Intervention	Exercise and Nutritional Supplement	The intervention will consist of an exercise intervention, a combination of supervised exercise classes and in home exercises and open label nutritional supplement.

Primary Outcome Measures

Name	Time	Method
Rate of identification of eligible patients	1 year	The primary outcome will be the number of patients that meet eligibility criteria.
The change in the rate of adherence to the trial interventions from baseline to 12 months	3 months, 6 months, 1 year	The intervention adherence of both the exercise intervention and nutritional supplement
The proportion of eligible patients consenting to participate and randomized	1 year	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
Barriers and facilitators of adherence to the intervention	1 year	The identification of barriers to exercise and nutritional supplement adherence

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada