Not provided
Not provided
Not provided
Not provided
Due to COVID-19 Pandemic Recruitment was not started
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frailty biomarker levels | The change in frailty biomarkers (not yet determined) from baseline to 12 months | 1 year |
| Physical activity levels as measured by the cardiac device (Permanent pacemaker or Implantable cardioverter defibrillator) |
Not provided
Inclusion Criteria
Exclusion criteria
Patients will be eligible for the registry but not eligible for the randomized control trial if they fulfill any of:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Darryl Leong, PhD. MBBSm | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000073496 | Frailty |
| D002318 | Cardiovascular Diseases |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The change in the volume of physical activity as detected by device (hours per day)
| 1 year |
| 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 |
| Cardiac device complications | The rate of occurrence of inappropriate defibrillator shocks or lead dislodgement | 1 year |
| Injury from a fall or fractures | The rate of occurrence of injury from a fall or fracture | 1 year |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |