Coronary Heart DiseaseNCT02168712
Interval Versus Continuous Training on Functional Capacity and Quality of Life in Patients With Coronary Artery Disease
A study testing Moderate continuous exercise training and Interval exercise training in people with Coronary Heart Disease, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
Exercise therapy increase functional capacity improving the morbidity and mortality of patients with cardiovascular disease. Moderate continuous training is the best established training modality for this patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Moderate continuous exercise training and Interval exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2011to Apr 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary heart Disease, with functional class II-III according to New York Heart Association classification system.
- At least 4 weeks from acute cardiac event, percutaneous or surgery revascularization.
- Optimized medical treatment in adequate doses ( betablockers, ACE inhibitors, ARA II, statins and antiplatelet drugs)
- Age > 18 years old.
- Willing to participate and sign an informed consent form
Who cannot join
- Residual ischemia waiting for revascularization.
- Any cardiac event for the last 4 weeks
- Abnormal Ergometry with hemodynamic or clinically significant arrhythmias during the procedure.
- History of severe ventricular arrhythmia
- Uncontrolled glycaemia or blood pressure
- Moderate to severe Chronic Pulmonary Obstructive Disease
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- Osteomuscular and/or mental disorder that hampers an adequate adherence to the intervention program
- Other vascular diseases: rheumatologic/ autoimmune disorders, thrombopathies, hemophilia.
- Active oncologic disease.
- Treatment with corticosteroids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interval Versus Continuous Exercise Training on Functional Capacity and Quality of Life in Patients With Coronary Artery Disease: a Randomized Clinical Trial
Exercise therapy increase functional capacity improving the morbidity and mortality of patients with cardiovascular disease. Moderate continuous training is the best established training modality for this patients. However, a body of evidence has begun to emerge demonstrating that high intensity interval training obtained better results in terms of morbidity and mortality.
The purpose of this randomized clinical trial was to determine the effect of two types of exercise training: moderate continuous training vs high interval training on functional capacity and quality of life as well as verify the safety in its application.
We included 72 patients with coronary artery disease by assigning one of the training modality for 8 weeks. We analyzed cyclo-ergo-spirometry data, aspect related to quality of life as well as a record of adverse events.
- Conditions
- Coronary Heart Disease
- Being tested
- Moderate continuous exercise training, Interval exercise training
- Keywords
- Coronary Heart Disease, Interval exercise training, Continuous exercise training, Quality of life, Safety
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate continuous exercise trainingOther
Interval exercise trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Moderate continuous exercise training | Active comparator | Moderate intensity continuous exercise training Receives: Other: Moderate continuous exercise training |
| Interval exercise training | Experimental | High intensity interval exercise training Receives: Other: Interval exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on functional capacity
Basal and peak oxygen consumption values will be measured.
Measured: 2 months
Secondary outcomes (1)
quality of life
Quality of life will be compared between the two arms with one generic questionnaire (SF-36) and one ischemic heart disease specific questionnaire (MacNew)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startNov 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KOLDO VILLELABEITIA JAUREGUIZAR, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168712
- Sponsor's protocol ID
- EO31/2013-HIE
- Status last verified
- Jun 2014
- First submitted
- 16 Jun 2014
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interval Versus Continuous Exercise Training on Functional Capacity and Quality of Life in Patients With Coronary Artery Disease: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02168712
- Acronym / sponsor ID
- EO31/2013-HIE
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary Heart Disease, Interval exercise training, Continuous exercise training, Quality of life, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 20 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.
Exercise therapy increase functional capacity improving the morbidity and mortality of patients with cardiovascular disease. Moderate continuous training is the best established training modality for this patients. However, a body of evidence has begun to emerge demonstrating that high intensity interval training obtained better results in terms of morbidity and mortality.
The purpose of this randomized clinical trial was to determine the effect of two types of exercise training: moderate continuous training vs high interval training on functional capacity and quality of life as well as verify the safety in its application.
We included 72 patients with coronary artery disease by assigning one of the training modality for 8 weeks. We analyzed cyclo-ergo-spirometry data, aspect related to quality of life as well as a record of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate continuous exercise training | Active comparator | Other: Moderate continuous exercise trainingModerate intensity continuous exercise training |
| Interval exercise training | Experimental | Other: Interval exercise trainingHigh intensity interval exercise training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Coronary heart Disease, with functional class II-III according to New York Heart Association classification system.
- At least 4 weeks from acute cardiac event, percutaneous or surgery revascularization.
- Optimized medical treatment in adequate doses ( betablockers, ACE inhibitors, ARA II, statins and antiplatelet drugs)
- Age > 18 years old.
- Willing to participate and sign an informed consent form
Key exclusion criteria (10 listed)
- Residual ischemia waiting for revascularization.
- Any cardiac event for the last 4 weeks
- Abnormal Ergometry with hemodynamic or clinically significant arrhythmias during the procedure.
- History of severe ventricular arrhythmia
- Uncontrolled glycaemia or blood pressure
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 |
|---|---|---|
| Moderate continuous exercise training | Other | Moderate continuous exercise training |
| Interval exercise training | Other | Interval exercise training |
Primary outcome
Impact on functional capacity
Time frame: 2 months
Basal and peak oxygen consumption values will be measured.
1 secondary outcome
quality of life
Time frame: 2 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 20 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate continuous exercise training and Interval exercise training in people with Coronary Heart Disease, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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 5 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: finished, as of the sponsor's last update on 20 Jun 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 Spain. 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?
Impact on functional capacity (time frame: 2 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 20 Jun 2014.