Cardiovascular Disease, ArrhythmiasPhase 1CARE-ENCT00845091
Cardiac Autonomic Regulation Enhancement Through Exercise Trial
A Phase 1 study testing Exercise and Heart Healthy Education in people with Cardiovascular Disease, Arrhythmias, run by The Miriam Hospital at 1 site in United States.
Trial summary
The current research study proposes to examine participants with implantable cardioverter defibrillators (ICD) who are randomly assigned to either an exercise training program intervention or a heart healthy education program intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Arrhythmias
- What is being tested?
- Exercise and Heart Healthy Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jul 2011
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult ICD patients (≥ 18 years of age)
- received an ICD for secondary prevention, cardiac diagnosis of: ventricular fibrillation, OR ventricular tachycardia, OR cardiac arrest, OR syncope with ventricular tachycardia inducible by programmed stimulation (EPS), AND
- either diagnosed coronary artery disease AND/OR prior myocardial infarction, or non-ischemic dilated cardiomyopathy
- meet functional NYHA Class I or II heart failure or angina symptoms
- ICD patients need to be sedentary, defined as not engaging in structured exercise more than once weekly, or an accumulation of less than 60 minutes of moderate intensity aerobic activity over the course of the week, for the past 3 months.
- deemed medically stable by their cardiologist and have received approval by their cardiologist to engage in an exercise program
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- Stable (unchanged) cardiac and psychopharmacologic medications in the 3 months prior to study enrollment
- Able to read and write English
- able to commit to the 3-month exercise/heart healthy program attending 3 times per week (36 sessions)
- able to commit to the 3 assessments (pre, post-treatment, 3-month follow-up; 6-month duration)
Who cannot join
- Patients who meet functional NYHA Class III or IV heart failure or angina symptoms
- sinus node dysfunction that requires atrial pacing
- atrial fibrillation
- bi-ventricular ICD
- are pacemaker-dependent
- diagnosis of Brugada's Syndrome
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- diagnosis of arrhythmogenic right ventricular dysplasia
- complex congenital heart disease
- orthopedic restrictions, limitations, or disabilities that would jeopardize the patient's safety during exercise or form completing the treadmill stress test
- Neurocognitive or cognitive impairments that will result in nonadherence (based on clinical evaluation)
- Unstable angina
- resting systolic blood pressure >180mmHg or resting diastolic blood pressure >110mm Hg will be evaluated on a case-by-case basis
- orthostatic blood pressure drop of >20mm Hg with symptoms
- critical aortic stenosis (peak systolic pressure gradient >50mm Hg with aortic valve orifice area <0.75cm2 in average size adult)
- acute systemic illness or fever
- uncontrolled atrial or ventricular arrhythmias
- uncontrolled sinus tachycardia (>120 beats/min)
- uncompensated CHF
- 3rd degree AV block (without pacemaker)
- active pericarditis or myocarditis
- recent embolism; thrombophlebitis
- resting ST segment displacement (>2mm)
- uncontrolled diabetes (resting blood glucose >400mg/dl)
- metabolic problems, such as acute, hypo or hyperkalemia, hypovolemia
- recent strongly positive exercise test as achieved by: significant decrease in systolic blood pressure with increasing workload, OR early onset, horizontal or downsloping ST segment depression (4mm), OR prolonged electrocardiogram (ECG) changes during recovery
- hypertrophic obstructive cardiomyopathy
- severe pulmonary hypertension
- patients who do not pass the exercise stress test
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miriam Hospital Centers for Behavioral and Preventive Medicine
Providence, Rhode Island, 02903
About this study
The current research study proposes to examine participants with implantable cardioverter defibrillators (ICD) who are randomly assigned to either an exercise training program intervention or a heart healthy education program intervention. We will look at changes in the functioning of the autonomic nervous system over time and between intervention groups. We are also going to be looking at changes in frequencies of the ICD participants' heart arrhythmias and ICD therapies (e.g., pacing, shock).; as well as, changes in exercise tolerance, psychological well-being, and quality of life.
- Conditions
- Cardiovascular Disease, Arrhythmias
- Being tested
- Exercise, Heart Healthy Education
- Keywords
- Parasympathetic activity, Exercise, Education, Arrhythmias, Defibrillators, Implantable
- Medical subject headings
- Cardiovascular Diseases, Arrhythmias, Cardiac, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
moderate-intensity, low-impact, supervised, aerobic exercise
Heart Healthy EducationBehavioural
Educational topics related to heart health (e.g., nutrition, smoking, sleep)
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | moderate-intensity, low-impact, supervised, aerobic exercise Receives: Behavioral: Exercise |
| Heart Healthy Education | Active comparator | Educational topics on heart health (e.g., nutrition, smoking, sleep) Receives: Behavioral: Heart Healthy Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
parasympathetic activity and regulation
Measured: 3 months, 6 months
Secondary outcomes (5)
arrhythmia frequency
Measured: 3 months, 6 months
ICD therapy frequency
Measured: 3 months, 6 months
exercise tolerance
Measured: 3 months, 6 months
psychological well-being
Measured: 3 months, 6 months
quality of life
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Disease, ArrhythmiasStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva R. Serber, The Miriam Hospital
- Investigators
- Eva R Serber, Ph.D., Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845091
- Sponsor's protocol ID
- HL092340
- Other IDs
- R21HL092340-01A1, RIH IRB, CMTT: 0177-08
- Acronym
- CARE-E
- Status last verified
- Jan 2014
- First submitted
- 13 Feb 2009
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Palmer K, Tilkemeier PL, Buxton AE, Niaura R, Marcus B, Todaro J, Serber ER. Ratings of perceived exertion and physiological responses during exercise testing among ICD patients. Poster presented at the 32nd Annual Meeting of the Society for Behavioral Medicine, New Orleans, LA.; Abstract B-1621, Rapid Communications, April 2012.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Autonomic Regulation Enhancement Through Exercise Trial
- ClinicalTrials.gov ID
- NCT00845091
- Acronym / sponsor ID
- CARE-E / HL092340
- Conditions
- Cardiovascular Disease, Arrhythmias
- Keywords
- Parasympathetic activity, Exercise, Education, Arrhythmias, Defibrillators, Implantable
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 Feb 2009 (estimated)
- 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.
The current research study proposes to examine participants with implantable cardioverter defibrillators (ICD) who are randomly assigned to either an exercise training program intervention or a heart healthy education program intervention. We will look at changes in the functioning of the autonomic nervous system over time and between intervention groups. We are also going to be looking at changes in frequencies of the ICD participants' heart arrhythmias and ICD therapies (e.g., pacing, shock).; as well as, changes in exercise tolerance, psychological well-being, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercisemoderate-intensity, low-impact, supervised, aerobic exercise |
| Heart Healthy Education | Active comparator | Behavioral: Heart Healthy EducationEducational topics on heart health (e.g., nutrition, smoking, sleep) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- adult ICD patients (≥ 18 years of age)
- received an ICD for secondary prevention, cardiac diagnosis of: ventricular fibrillation, OR ventricular tachycardia, OR cardiac arrest, OR syncope with ventricular tachycardia inducible by programmed stimulation (EPS), AND
- either diagnosed coronary artery disease AND/OR prior myocardial infarction, or non-ischemic dilated cardiomyopathy
- meet functional NYHA Class I or II heart failure or angina symptoms
- ICD patients need to be sedentary, defined as not engaging in structured exercise more than once weekly, or an accumulation of less than 60 minutes of moderate intensity aerobic activity over the course of the week, for the past 3 months.
Key exclusion criteria (28 listed)
- Patients who meet functional NYHA Class III or IV heart failure or angina symptoms
- sinus node dysfunction that requires atrial pacing
- atrial fibrillation
- bi-ventricular ICD
- are pacemaker-dependent
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 |
|---|---|---|
| Exercisemoderate-intensity, low-impact, supervised, aerobic exercise | Behavioural | Exercise |
| Heart Healthy EducationEducational topics related to heart health (e.g., nutrition, smoking, sleep) | Behavioural | Heart Healthy Education |
Primary outcome
parasympathetic activity and regulation
Time frame: 3 months, 6 months
5 secondary outcomes
arrhythmia frequency
Time frame: 3 months, 6 months
ICD therapy frequency
Time frame: 3 months, 6 months
exercise tolerance
Time frame: 3 months, 6 months
psychological well-being
Time frame: 3 months, 6 months
quality of life
Time frame: 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
- BackgroundPalmer K, Tilkemeier PL, Buxton AE, Niaura R, Marcus B, Todaro J, Serber ER. Ratings of perceived exertion and physiological responses during exercise testing among ICD patients. Poster presented at the 32nd Annual Meeting of the Society for Behavioral Medicine, New Orleans, LA.; Abstract B-1621, Rapid Communications, April 2012.
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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.
Eva R Serber, Ph.D. principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exercise and Heart Healthy Education in people with Cardiovascular Disease, Arrhythmias, run by The Miriam Hospital at 1 site in United States.
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 10 inclusion and 28 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: finished, as of the sponsor's last update on 8 Jan 2014. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
parasympathetic activity and regulation (time frame: 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00845091, which also lists 1 linked publication.
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 8 Jan 2014.