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

Primary Purpose

Frailty, Cardiovascular Diseases

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise and Nutritional Supplement
Sponsored by
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty focused on measuring Exercise, Nutritional Supplement, Physical Function, Quality of Life, Cardiac Device, Physical Activity, Defibrillators, Pacemakers, Biomarkers

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hamilton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Randomized Intervention

Randomized - Control

Arm Description

The intervention will consist of an exercise intervention, a combination of supervised exercise classes and in home exercises and open label nutritional supplement.

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

Outcomes

Primary Outcome Measures

Rate of identification of eligible patients
The primary outcome will be the number of patients that meet eligibility criteria.
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
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
Barriers and facilitators of adherence to the intervention
The identification of barriers to exercise and nutritional supplement adherence

Secondary Outcome Measures

Frailty biomarker levels
The change in frailty biomarkers (not yet determined) from baseline to 12 months
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)
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
Cardiac device complications
The rate of occurrence of inappropriate defibrillator shocks or lead dislodgement
Injury from a fall or fractures
The rate of occurrence of injury from a fall or fracture

Full Information

First Posted
July 22, 2019
Last Updated
August 19, 2022
Sponsor
Population Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04052672
Brief Title
Diet and Exercise Frailty Intervention in Cardiac Device Patients
Acronym
DEFINIT-P
Official Title
Diet and Exercise Frailty Intervention in Cardiac Device Patients Trial Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Due to COVID-19 Pandemic Recruitment was not started
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Population Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Cardiovascular Diseases
Keywords
Exercise, Nutritional Supplement, Physical Function, Quality of Life, Cardiac Device, Physical Activity, Defibrillators, Pacemakers, Biomarkers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Randomized Intervention
Arm Type
Active Comparator
Arm Description
The intervention will consist of an exercise intervention, a combination of supervised exercise classes and in home exercises and open label nutritional supplement.
Arm Title
Randomized - Control
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Exercise and Nutritional Supplement
Intervention Description
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).
Primary Outcome Measure Information:
Title
Rate of identification of eligible patients
Description
The primary outcome will be the number of patients that meet eligibility criteria.
Time Frame
1 year
Title
The proportion of eligible patients consenting to participate and randomized
Description
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
Title
The change in the rate of adherence to the trial interventions from baseline to 12 months
Description
The intervention adherence of both the exercise intervention and nutritional supplement
Time Frame
3 months, 6 months, 1 year
Title
Barriers and facilitators of adherence to the intervention
Description
The identification of barriers to exercise and nutritional supplement adherence
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Frailty biomarker levels
Description
The change in frailty biomarkers (not yet determined) from baseline to 12 months
Time Frame
1 year
Title
Physical activity levels as measured by the cardiac device (Permanent pacemaker or Implantable cardioverter defibrillator)
Description
The change in the volume of physical activity as detected by device (hours per day)
Time Frame
1 year
Title
Myocardial infarction, stroke, heart failure hospitalization, atrial fibrillation or ventricular tachyarrhythmia
Description
The rate of occurrence of myocardial infarction, stroke, heart failure hospitalization, atrial fibrillation or ventricular tachyarrhythmia
Time Frame
1 year
Title
Cardiac device complications
Description
The rate of occurrence of inappropriate defibrillator shocks or lead dislodgement
Time Frame
1 year
Title
Injury from a fall or fractures
Description
The rate of occurrence of injury from a fall or fracture
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Permanent pacemaker recipients OR Implantable cardioverter defibrillator recipients Exclusion criteria Age <55 years, or Unwilling to consent Patients will be eligible for the registry but not eligible for the randomized control trial if they fulfill any of: Are non-frail Already undertaking >1 hour per week of dedicated exercise Existing or prior referral for cardiac rehabilitation Moderate or severe heart failure (New York Heart Association class III or IV) Unstable angina Any other medical condition that will prevent exercise participation Dementia, as identified by a Mini-Mental State Examination score <25
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darryl Leong, PhD. MBBSm
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Diet and Exercise Frailty Intervention in Cardiac Device Patients

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