Diet and Exercise Frailty Intervention in Cardiac Device Patients

NCT04052672 | Withdrawn

• 1 other identifier: DEFINIT_001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Cardiovascular Diseases

Keywords

Exercise; Nutritional Supplement; Physical Function; Quality of Life; Cardiac Device; Physical Activity; Defibrillators; Pacemakers; Biomarkers

Outcome Measures

Primary Outcomes (4)

• Rate of identification of eligible patients

  The primary outcome will be the number of patients that meet eligibility criteria.

  1 year

• 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

• 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

• Barriers and facilitators of adherence to the intervention

  The identification of barriers to exercise and nutritional supplement adherence

  1 year

Secondary Outcomes (5)

• Frailty biomarker levels

  1 year

• Physical activity levels as measured by the cardiac device (Permanent pacemaker or Implantable cardioverter defibrillator)

  1 year

• Myocardial infarction, stroke, heart failure hospitalization, atrial fibrillation or ventricular tachyarrhythmia

  1 year

• Cardiac device complications

  1 year

• Injury from a fall or fractures

  1 year

Study Arms (2)

Randomized Intervention

ACTIVE COMPARATOR

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

Other: Exercise and Nutritional Supplement

Randomized - Control

NO INTERVENTION

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

Interventions

Exercise and Nutritional Supplement OTHER

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).

Randomized Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Permanent pacemaker recipients OR
• Implantable cardioverter defibrillator recipients

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Conditions

Frailty; Cardiovascular Diseases; Motor Activity

Interventions

Exercise; Dietary Supplements

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Darryl Leong, PhD. MBBSm

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: August 12, 2019
• Study Start: November 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)