Status:
WITHDRAWN
Diet and Exercise Frailty Intervention in Cardiac Device Patients
Lead Sponsor:
Population Health Research Institute
Conditions:
Frailty
Cardiovascular Diseases
Eligibility:
All Genders
55+ years
Phase:
NA
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 supplemen...
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 e...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04052672
Start Date
November 1 2019
End Date
December 30 2020
Last Update
August 23 2022
Active Locations (1)
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1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2