Ischemic Heart DiseaseNCT01912690
The Influence of Different Training Regimens on Electrical Stability Following Myocardial Infarction
A study testing aerobic training and aerobic and strength training in people with Ischemic Heart Disease and Congestive Heart Failure, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The hypothesis of the study is that aerobic conditioning following acute heart attack will improve autonomic function and electrical stability of the heart. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Heart Disease, Congestive Heart Failure
- What is being tested?
- aerobic training and aerobic and strength training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2013to Jan 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- s/p acute myocardial infarction 14-30 days
- ability to perform exercise
Who cannot join
- unstable angina
- chronic atrial fibrillation
- severely reduced LV function
- NYHA 4
- severe valvular disease
Trial locations and contacts
1 site in 1 country.
About this study
The hypothesis of the study is that aerobic conditioning following acute heart attack will improve autonomic function and electrical stability of the heart.
- Conditions
- Ischemic Heart Disease, Congestive Heart Failure
- Being tested
- aerobic training, aerobic and strength training
- Medical subject headings
- Myocardial Ischemia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic trainingOther
aerobic and strength trainingOther
| Study group | Role | What they receive |
|---|---|---|
| standard of care | Placebo comparator | Not described |
| aerobic training only | Active comparator | Not described Receives: Other: aerobic training |
| Aerobic and strength training | Active comparator | Not described Receives: Other: aerobic and strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventrcular dyssynchrony
Assessed by 2-D strain imaging
Measured: 3 months
Secondary outcomes (1)
Autonomic function
Assessed by Holter
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912690
- Sponsor's protocol ID
- TRAINING
- Status last verified
- Aug 2015
- First submitted
- 29 Jul 2013
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Different Training Regimens on Electrical Stability Following Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01912690
- Acronym / sponsor ID
- TRAINING
- Conditions
- Ischemic Heart Disease, Congestive Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jan 2015 (actual)
- First posted
- 31 Jul 2013 (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 hypothesis of the study is that aerobic conditioning following acute heart attack will improve autonomic function and electrical stability of the heart.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard of care | Placebo comparator | – |
| aerobic training only | Active comparator | Other: aerobic training |
| Aerobic and strength training | Active comparator | Other: aerobic and strength training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- s/p acute myocardial infarction 14-30 days
- ability to perform exercise
Key exclusion criteria (5 listed)
- unstable angina
- chronic atrial fibrillation
- severely reduced LV function
- NYHA 4
- severe valvular disease
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 |
|---|---|---|
| aerobic training | Other | aerobic training only |
| aerobic and strength training | Other | Aerobic and strength training |
Primary outcome
Left ventrcular dyssynchrony
Time frame: 3 months
Assessed by 2-D strain imaging
1 secondary outcome
Autonomic function
Time frame: 3 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 22 Sep 2015.
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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 aerobic training and aerobic and strength training in people with Ischemic Heart Disease and Congestive Heart Failure, run by Hadassah Medical Organization 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 2 inclusion and 5 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 22 Sep 2015. 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. 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.
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?
Left ventrcular dyssynchrony (time frame: 3 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 22 Sep 2015.