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

Population Health Research Institute (PHRI)

Status: Withdrawn

Conditions: Cardiovascular Diseases; Frailty

Treatments: Other: Exercise and Nutritional Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT04052672

DEFINIT_001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Randomized Intervention

Active Comparator group

Description:

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

Treatment:

Other: Exercise and Nutritional Supplement

Randomized - Control

No Intervention group

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