Myocardial InfarctionPhase 1/2NCT02224495
The Effect of Exercise Training on Cardiac Structure and Function
A Phase 1/2 study testing Structured exercise training in people with Myocardial Infarction, run by Gaia Hospital at 1 site in Portugal.
Trial summary
Exercise training, as part of cardiac rehabilitation, is effective in improving functional capacity and quality of life in patients with coronary artery disease. Other cardiovascular and non-cardiovascular benefits have been reported, namely in glucose metabolism, skeletal muscle function, oxidative stress, vascular… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Structured exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2011to May 2013
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients one month after myocardial infarction
- Older 18 years
Who cannot join
- Age above 75 years,
- Inability to exercise,
- Hemodinamically significant valvular disease,
- Moderate to severe chronic lung disease (vital capacity and/or forced expiratory volume in 1 s <80% of age-dependent predicted value),
- Atrial fibrillation
- Exercise induced myocardial ischemia
- Anaemia (haemoglobin <12 g/dl).
Trial locations and contacts
1 site in 1 country.
About this study
Exercise training, as part of cardiac rehabilitation, is effective in improving functional capacity and quality of life in patients with coronary artery disease. Other cardiovascular and non-cardiovascular benefits have been reported, namely in glucose metabolism, skeletal muscle function, oxidative stress, vascular function, pulmonary circulation, ischaemia-reperfusion lesion and ventricular remodelling.
However, the benefit of exercise training on systolic and diastolic function is controversial especially after acute myocardial infarction where no longitudinal study has evaluated diastolic function using modern echocardiographic parameters.
The hypothesis is that a structured program of exercise training can improve systolic and diastolic function in patients after myocardial infarction.
- Conditions
- Myocardial Infarction
- Being tested
- Structured exercise training
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured exercise trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Standard of care |
| Structured exercise training | Experimental | 8-week outpatient exercise-training program, encompassing 3 sessions per week, including endurance and resistance training Receives: Behavioral: Structured exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial early diastolic velocity at mitral annulus by tissue Doppler (E' velocity)
Determined by echocardiography; results in cm/s
Measured: 4 months
Secondary outcomes (3)
Ratio between early diastolic filling velocity from mitral inflow and myocardial early diastolic velocity at mitral annulus by tissue Doppler (E/E' ratio)
Determined by echocardiography; no unit (ratio)
Measured: 4 months
Myocardial systolic velocity at mitral annulus by tissue Doppler (S' velocity)
Determined by echocardiography; results in cm/s
Measured: 4 months
Left ventriclular ejection fraction
Determined by echocardiography; results in %
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startSep 2011
- Primary completionDec 2012
- Study completionMay 2013
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 Myocardial InfarctionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaia Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Porto
- Responsible party
- Principal investigator, Ricardo Fontes Carvalho, Gaia Hospital
- Investigators
- Adelino Leite-Moreira, PhD, Study director, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224495
- Sponsor's protocol ID
- ET2011
- Status last verified
- Aug 2014
- First submitted
- 21 Aug 2014
- Last updated
- 25 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Fontes-Carvalho R, Sampaio F, Teixeira M, Gama V, Leite-Moreira AF. The role of a structured exercise training program on cardiac structure and function after acute myocardial infarction: study protocol for a randomized controlled trial. Trials. 2015 Mar 12;16:90. doi: 10.1186/s13063-015-0612-6.
PubMed 25872588
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise Training on Cardiac Structure and Function
- ClinicalTrials.gov ID
- NCT02224495
- Acronym / sponsor ID
- ET2011
- Conditions
- Myocardial Infarction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Gaia HospitalUniversity, hospital or other
- Collaborators
- Universidade do Porto
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Aug 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 training, as part of cardiac rehabilitation, is effective in improving functional capacity and quality of life in patients with coronary artery disease. Other cardiovascular and non-cardiovascular benefits have been reported, namely in glucose metabolism, skeletal muscle function, oxidative stress, vascular function, pulmonary circulation, ischaemia-reperfusion lesion and ventricular remodelling.
However, the benefit of exercise training on systolic and diastolic function is controversial especially after acute myocardial infarction where no longitudinal study has evaluated diastolic function using modern echocardiographic parameters.
The hypothesis is that a structured program of exercise training can improve systolic and diastolic function in patients after myocardial infarction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | –Standard of care |
| Structured exercise training | Experimental | Behavioral: Structured exercise training8-week outpatient exercise-training program, encompassing 3 sessions per week, including endurance and resistance training |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients one month after myocardial infarction
- Older 18 years
Key exclusion criteria (7 listed)
- Age above 75 years,
- Inability to exercise,
- Hemodinamically significant valvular disease,
- Moderate to severe chronic lung disease (vital capacity and/or forced expiratory volume in 1 s <80% of age-dependent predicted value),
- Atrial fibrillation
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 |
|---|---|---|
| Structured exercise training | Behavioural | Structured exercise training |
Primary outcome
Myocardial early diastolic velocity at mitral annulus by tissue Doppler (E' velocity)
Time frame: 4 months
Determined by echocardiography; results in cm/s
3 secondary outcomes
Ratio between early diastolic filling velocity from mitral inflow and myocardial early diastolic velocity at mitral annulus by tissue Doppler (E/E' ratio)
Time frame: 4 months
Myocardial systolic velocity at mitral annulus by tissue Doppler (S' velocity)
Time frame: 4 months
Left ventriclular ejection fraction
Time frame: 4 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 25 Aug 2014.
- Derived from this study: PubMed 25872588Fontes-Carvalho R, Sampaio F, Teixeira M, Gama V, Leite-Moreira AF. The role of a structured exercise training program on cardiac structure and function after acute myocardial infarction: study protocol for a randomized controlled trial. Trials. 2015 Mar 12;16:90. doi: 10.1186/s13063-015-0612-6.
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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.
Adelino Leite-Moreira, PhD study director
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Structured exercise training in people with Myocardial Infarction, run by Gaia Hospital at 1 site in Portugal.
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 7 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 25 Aug 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 Portugal. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Myocardial early diastolic velocity at mitral annulus by tissue Doppler (E' velocity) (time frame: 4 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 NCT02224495, 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 25 Aug 2014; AzTrials last refreshed its copy on 26 Oct 2026.