Coronary Artery DiseaseNCT02162290
Comparison Between Moderate-high Interval Exercise and Moderate Continuous Exercise in an Advanced Cardiac Rehabilitation Program
A study testing Interval exercise training and Continuous exercise training in people with Coronary Artery Disease and Myocardial Infarction, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The research will study the differences between interval training and continuous training among cardiac patients in a cardiac rehabilitation facility. The main objectives are: 1. Functional capacity measures (VO2 max). 2. Cardiac risk factors 3. Quality of life assessments. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction
- What is being tested?
- Interval exercise training and Continuous exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteIsrael
- Study dates
- May 2011to May 2015
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergone:
- Myocardial infarction
- Percutaneous transluminal coronary angioplasty
- Coronary artery bypass graft
Who cannot join
- Patients with:
- Severe ischemia or angina
- Implantable cardioverter-defibrillator
- Pacemakers transplants
- Severe left ventricular dysfunctions
- Uncontrolled arrhythmias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Moderate-high Interval Exercise and Moderate Continuous Exercise in an Advanced Cardiac Rehabilitation Program - Nine Months Follow up
The research will study the differences between interval training and continuous training among cardiac patients in a cardiac rehabilitation facility.
The main objectives are:
- Functional capacity measures (VO2 max).
- Cardiac risk factors
- Quality of life assessments.
Study hypothesis:
Interval training will be more effective in improving functional capacity, cardiac risk factors and quality of life, compared to continuous training.
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Being tested
- Interval exercise training, Continuous exercise training
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval exercise trainingOther
Exercise bouts in low and high intensities
Continuous exercise trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Interval exercise | Experimental | Exercise bouts in low and high intensities Receives: Other: Interval exercise training |
| Continuous exercise | Experimental | Exercise continuously with moderate intensity Receives: Other: Continuous exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal functional capacity
Outcome is assessed at baseline, after 3 months and at nine months
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startMay 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yael Pernick, Principal investigator, Asaf Harofe Medical CenterZyssman, MD, Study director, Asaf Harofe Medical CenterJonathan Moore, PhD, Study director, Bangor UniversityZvi Vered, MD, Study director, Asaf Harofe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162290
- Sponsor's protocol ID
- 2*175/10
- Status last verified
- May 2016
- First submitted
- 11 Jun 2014
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Moderate-high Interval Exercise and Moderate Continuous Exercise in an Advanced Cardiac Rehabilitation Program - Nine Months Follow up
- ClinicalTrials.gov ID
- NCT02162290
- Acronym / sponsor ID
- 2*175/10
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- May 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 Jun 2014 (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 research will study the differences between interval training and continuous training among cardiac patients in a cardiac rehabilitation facility.
The main objectives are:
- Functional capacity measures (VO2 max).
- Cardiac risk factors
- Quality of life assessments.
Study hypothesis:
Interval training will be more effective in improving functional capacity, cardiac risk factors and quality of life, compared to continuous training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interval exercise | Experimental | Other: Interval exercise trainingExercise bouts in low and high intensities |
| Continuous exercise | Experimental | Other: Continuous exercise trainingExercise continuously with moderate intensity |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergone:
Key exclusion criteria (6 listed)
- Patients with:
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 |
|---|---|---|
| Interval exercise trainingExercise bouts in low and high intensities | Other | Interval exercise |
| Continuous exercise training | Other | Continuous exercise |
Primary outcome
Maximal functional capacity
Time frame: 9 months
Outcome is assessed at baseline, after 3 months and at nine 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 17 May 2016.
Related trials for Coronary Artery Disease
Recruiting
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Active, not recruitingObservational study
Post-Induction Low Cardiac Output Syndrome in Coronary Artery Bypass Graft Surgery
Cardiac Output, Low, Coronary Arterial Disease
RecruitingPhase 3
A Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery.
Coronary Artery Disease (CAD), Coronary Artery Bypass Graft Surgery(CABG)
Enrolling by invitationObservational study
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
Non-obstructive Coronary Disease, Acute or Chronic Coronary Artery Disease
Recruiting
Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma
Melanoma
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.
Yael Pernick principal investigator
Asaf Harofe Medical Center
Zyssman, MD study director
Asaf Harofe Medical Center
Jonathan Moore, PhD study director
Bangor 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 Interval exercise training and Continuous exercise training in people with Coronary Artery Disease and Myocardial Infarction, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 4 inclusion and 6 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 17 May 2016. 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 Israel. 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 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?
Maximal functional capacity (time frame: 9 months). 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 17 May 2016.