Diet and Exercise Frailty Intervention in Cardiac Device Patients

Cardiovascular Diseases Clinical Trial

— DEFINIT-P  

Official title:

Diet and Exercise Frailty Intervention in Cardiac Device Patients Trial Pilot

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04052672
• Other study ID #: DEFINIT_001
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2022
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Frailty

Intervention

Other:
• Exercise and Nutritional Supplement
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).

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of identification of eligible patients	The primary outcome will be the number of patients that meet eligibility criteria.	1 year
Primary	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	1 year
Primary	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	3 months, 6 months, 1 year
Primary	Barriers and facilitators of adherence to the intervention	The identification of barriers to exercise and nutritional supplement adherence	1 year
Secondary	Frailty biomarker levels	The change in frailty biomarkers (not yet determined) from baseline to 12 months	1 year
Secondary	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)	1 year
Secondary	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	1 year
Secondary	Cardiac device complications	The rate of occurrence of inappropriate defibrillator shocks or lead dislodgement	1 year
Secondary	Injury from a fall or fractures	The rate of occurrence of injury from a fall or fracture	1 year