Clinical trial NCT04052672: Diet and Exercise Frailty Intervention in Cardiac Device Patients
Official title: Diet and Exercise Frailty Intervention in Cardiac Device Patients Trial Pilot
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Frailty
Cardiovascular Diseases
Keywords: Exercise
Nutritional Supplement
Physical Function
Quality of Life
Cardiac Device
Physical Activity
Defibrillators
Pacemakers
Biomarkers
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of identification of eligible patients
timeFrame: 1 year
measure: The proportion of eligible patients consenting to participate and randomized
timeFrame: 1 year
measure: The change in the rate of adherence to the trial interventions from baseline to 12 months
timeFrame: 3 months, 6 months, 1 year
measure: Barriers and facilitators of adherence to the intervention
timeFrame: 1 year
Secondary outcomes:
measure: Frailty biomarker levels
timeFrame: 1 year
measure: Physical activity levels as measured by the cardiac device (Permanent pacemaker or Implantable cardioverter defibrillator)
timeFrame: 1 year
measure: Myocardial infarction, stroke, heart failure hospitalization, atrial fibrillation or ventricular tachyarrhythmia
timeFrame: 1 year
measure: Cardiac device complications
timeFrame: 1 year
measure: Injury from a fall or fractures
timeFrame: 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Darryl Leong, PhD. MBBSm
role: PRINCIPAL_INVESTIGATOR
References: