Myocardial InfarctionNCT00964067
Aerobic Interval Training in Cardiac Rehabilitation
A study testing Exercise training in people with Myocardial Infarction and Coronary Artery Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of the study is to compare home-based aerobic interval training with supervised interval training performed in groups or on a treadmill at the hospital. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction, Coronary Artery Disease
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2009to Jul 2012
- 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
- coronary artery disease
- age over 18
- referred to cardiac rehabilitation
- exercise tolerance demonstrated
Who cannot join
- severe arrhythmia
- heart failure
- drug abuse
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of High Intensity Aerobic Interval Training in Cardiac Rehabilitation
The purpose of the study is to compare home-based aerobic interval training with supervised interval training performed in groups or on a treadmill at the hospital.
Read the detailed description
Cardiac rehabilitation is usually first offered in hospitals, but there are several studies that show that home-based rehabilitation is equally efficient. How this comes out when exercise is organized as aerobic interval training is not known.
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Being tested
- Exercise training
- Keywords
- rehabilitation outcome, cardiac patients, exercise intensity
- Medical subject headings
- Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Interval training at 90% of max heart rate. Warm-up of 10-15 minutes up to 70% of HRmax, then 4 minutes of exercise at 90%. 3 minutes of active pause between the intervals. Total 45 minutes of exercise. Twice a week.
| Study group | Role | What they receive |
|---|---|---|
| Treadmill group | Active comparator | Interval exercise performed on treadmills, supervised Receives: Other: Exercise training |
| Exercise groups | Active comparator | Supervised and organised in groups of ten Receives: Other: Exercise training |
| home-based exercise | Active comparator | Interval training at home, free choice of modality Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2peak
Measured: baseline, after 12 weeks and after 1 year
Secondary outcomes (1)
quality of life
Measured: baseline, 12 weeks and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Asbjørn Støylen, PhD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964067
- Sponsor's protocol ID
- HJERTEREHAB2009
- Status last verified
- Mar 2017
- First submitted
- 21 Aug 2009
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aamot IL, Karlsen T, Dalen H, Stoylen A. Long-term Exercise Adherence After High-intensity Interval Training in Cardiac Rehabilitation: A Randomized Study. Physiother Res Int. 2016 Mar;21(1):54-64. doi: 10.1002/pri.1619. Epub 2015 Feb 16.
PubMed 25689059Aamot IL, Forbord SH, Gustad K, Lockra V, Stensen A, Berg AT, Dalen H, Karlsen T, Stoylen A. Home-based versus hospital-based high-intensity interval training in cardiac rehabilitation: a randomized study. Eur J Prev Cardiol. 2014 Sep;21(9):1070-8. doi: 10.1177/2047487313488299. Epub 2013 Apr 23.
PubMed 23613224
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Intensity Aerobic Interval Training in Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT00964067
- Acronym / sponsor ID
- HJERTEREHAB2009
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Keywords
- rehabilitation outcome, cardiac patients, exercise intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Sep 2009 (actual)
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 24 Aug 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 purpose of the study is to compare home-based aerobic interval training with supervised interval training performed in groups or on a treadmill at the hospital.
Detailed description
Cardiac rehabilitation is usually first offered in hospitals, but there are several studies that show that home-based rehabilitation is equally efficient. How this comes out when exercise is organized as aerobic interval training is not known.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treadmill group | Active comparator | Other: Exercise trainingInterval exercise performed on treadmills, supervised |
| Exercise groups | Active comparator | Other: Exercise trainingSupervised and organised in groups of ten |
| home-based exercise | Active comparator | Other: Exercise trainingInterval training at home, free choice of modality |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- coronary artery disease
- age over 18
- referred to cardiac rehabilitation
- exercise tolerance demonstrated
Key exclusion criteria (4 listed)
- severe arrhythmia
- heart failure
- drug abuse
- pregnancy
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 |
|---|---|---|
| Exercise trainingInterval training at 90% of max heart rate. Warm-up of 10-15 minutes up to 70% of HRmax, then 4 minutes of exercise at 90%. 3 minutes of active pause between the intervals. Total 45 minutes of exercise. Twice a week. | Other | Exercise groups, Treadmill group, home-based exercise |
Primary outcome
VO2peak
Time frame: baseline, after 12 weeks and after 1 year
1 secondary outcome
quality of life
Time frame: baseline, 12 weeks and 1 year
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 Mar 2017.
- Results publication: PubMed 25689059Aamot IL, Karlsen T, Dalen H, Stoylen A. Long-term Exercise Adherence After High-intensity Interval Training in Cardiac Rehabilitation: A Randomized Study. Physiother Res Int. 2016 Mar;21(1):54-64. doi: 10.1002/pri.1619. Epub 2015 Feb 16.
- Results publication: PubMed 23613224Aamot IL, Forbord SH, Gustad K, Lockra V, Stensen A, Berg AT, Dalen H, Karlsen T, Stoylen A. Home-based versus hospital-based high-intensity interval training in cardiac rehabilitation: a randomized study. Eur J Prev Cardiol. 2014 Sep;21(9):1070-8. doi: 10.1177/2047487313488299. Epub 2013 Apr 23.
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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.
Asbjørn Støylen, PhD study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Myocardial Infarction and Coronary Artery Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
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 4 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 Mar 2017. 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 Norway. 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?
VO2peak (time frame: baseline, after 12 weeks and after 1 year). 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 NCT00964067, which also lists 2 linked publications.
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 Mar 2017.