NCT04052672

Diet and Exercise Frailty Intervention in Cardiac Device Patients

Diet and Exercise Frailty Intervention in Cardiac Device Patients Trial Pilot

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Frailty
• Cardiovascular Diseases

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-12-30
• Completion: 2020-12-30
• First posted: 2019-08-12
• Last updated: 2022-08-23

Locations

1 site across 1 country: Canada