FrailtyDEFINIT-PNCT04052672
Diet and Exercise Frailty Intervention in Cardiac Device Patients
A study testing Exercise and Nutritional Supplement in people with Frailty and Cardiovascular Diseases, run by Population Health Research Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Frailty, Cardiovascular Diseases
- What is being tested?
- Exercise and Nutritional Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2019to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Permanent pacemaker recipients OR
- Implantable cardioverter defibrillator recipients
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diet and Exercise Frailty Intervention in Cardiac Device Patients Trial Pilot
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.
Read the 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
- Being tested
- Exercise and Nutritional Supplement
- Keywords
- Exercise, Nutritional Supplement, Physical Function, Quality of Life, Cardiac Device, Physical Activity, Defibrillators, Pacemakers, Biomarkers
- Medical subject headings
- Frailty, Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and Nutritional SupplementOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of identification of eligible patients
The primary outcome will be the number of patients that meet eligibility criteria.
Measured: 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
Measured: 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
Measured: 3 months, 6 months, 1 year
Barriers and facilitators of adherence to the intervention
The identification of barriers to exercise and nutritional supplement adherence
Measured: 1 year
Secondary outcomes (5)
Frailty biomarker levels
The change in frailty biomarkers (not yet determined) from baseline to 12 months
Measured: 1 year
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)
Measured: 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
Measured: 1 year
Cardiac device complications
The rate of occurrence of inappropriate defibrillator shocks or lead dislodgement
Measured: 1 year
Injury from a fall or fractures
The rate of occurrence of injury from a fall or fracture
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start1 Nov 2019
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Why it stopped: Due to COVID-19 Pandemic Recruitment was not started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darryl Leong, PhD. MBBSm, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052672
- Sponsor's protocol ID
- DEFINIT_001
- Acronym
- DEFINIT-P
- Status last verified
- Aug 2022
- First submitted
- 22 Jul 2019
- Last updated
- 23 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Exercise Frailty Intervention in Cardiac Device Patients Trial Pilot
- ClinicalTrials.gov ID
- NCT04052672
- Acronym / sponsor ID
- DEFINIT-P / DEFINIT_001
- Conditions
- Frailty, Cardiovascular Diseases
- Keywords
- Exercise, Nutritional Supplement, Physical Function, Quality of Life, Cardiac Device, Physical Activity, Defibrillators, Pacemakers
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID-19 Pandemic Recruitment was not started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 12 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized Intervention | Active comparator | Other: Exercise and Nutritional SupplementThe 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 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Permanent pacemaker recipients OR
- Implantable cardioverter defibrillator recipients
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and Nutritional SupplementThe intervention consists of exercise (a combination of supervised and in home) as well as a nutritional supplement (a combination of whey protein and creatine). | Other | Randomized Intervention |
Primary outcome
Rate of identification of eligible patients
Time frame: 1 year
The primary outcome will be the number of patients that meet eligibility criteria.
The proportion of eligible patients consenting to participate and randomized
Time frame: 1 year
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
The change in the rate of adherence to the trial interventions from baseline to 12 months
Time frame: 3 months, 6 months, 1 year
The intervention adherence of both the exercise intervention and nutritional supplement
Barriers and facilitators of adherence to the intervention
Time frame: 1 year
The identification of barriers to exercise and nutritional supplement adherence
5 secondary outcomes
Frailty biomarker levels
Time frame: 1 year
Physical activity levels as measured by the cardiac device (Permanent pacemaker or Implantable cardioverter defibrillator)
Time frame: 1 year
Myocardial infarction, stroke, heart failure hospitalization, atrial fibrillation or ventricular tachyarrhythmia
Time frame: 1 year
Cardiac device complications
Time frame: 1 year
Injury from a fall or fractures
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darryl Leong, PhD. MBBSm principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Nutritional Supplement in people with Frailty and Cardiovascular Diseases, run by Population Health Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of identification of eligible patients (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.