ObesityNCT00839579
Cardiovascular Treatment
A study testing 1x4 min interval in people with Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Exercise training is proved to protect against premature cardiovascular mortality. Additionally there is evidence that relatively high exercise intensity may be an important factor for improving aerobic capacity and endothelial function in patients with post-infarction heart failure, metabolic syndrome, coronary… Read more about this study
- Who is it for?
- Ages 35 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- 1x4 min interval
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2009to Jun 2010
- 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 35 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI: 25-30
- Males, 35-45 years
- Healthy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Little Pain for Cardiac Gain? A Pilot Study
Exercise training is proved to protect against premature cardiovascular mortality. Additionally there is evidence that relatively high exercise intensity may be an important factor for improving aerobic capacity and endothelial function in patients with post-infarction heart failure, metabolic syndrome, coronary artery disease, as well as in overweight and obese individuals.
The aim of this study is to investigate the amount of high-intensity exercise needed to improve aerobic capacity and endothelial function.
- Conditions
- Obesity
- Being tested
- 1x4 min interval
- Keywords
- slightly overweight, males 35-45 years
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1x4 min intervalOther
Aerobic interval training
| Study group | Role | What they receive |
|---|---|---|
| 4x4min | Experimental | 4x4minutes interval group Receives: Other: 1x4 min interval |
| 1x4min | Experimental | Not described Receives: Other: 1x4 min interval |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen consumption and endothelial function
Measured: baseline and 12 weeks followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionJun 2010
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 ObesityStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnt E Tjønna, PhD, Study chair, Norwegian University of Science and TechnologyUlrik Wisløff, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839579
- Sponsor's protocol ID
- 1x4min interval
- Status last verified
- Mar 2014
- First submitted
- 6 Feb 2009
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tjonna AE, Leinan IM, Bartnes AT, Jenssen BM, Gibala MJ, Winett RA, Wisloff U. Low- and high-volume of intensive endurance training significantly improves maximal oxygen uptake after 10-weeks of training in healthy men. PLoS One. 2013 May 29;8(5):e65382. doi: 10.1371/journal.pone.0065382. Print 2013.
PubMed 23734250
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Little Pain for Cardiac Gain? A Pilot Study
- ClinicalTrials.gov ID
- NCT00839579
- Acronym / sponsor ID
- 1x4min interval
- Conditions
- Obesity
- Keywords
- slightly overweight, males 35-45 years
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 9 Feb 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.
Exercise training is proved to protect against premature cardiovascular mortality. Additionally there is evidence that relatively high exercise intensity may be an important factor for improving aerobic capacity and endothelial function in patients with post-infarction heart failure, metabolic syndrome, coronary artery disease, as well as in overweight and obese individuals.
The aim of this study is to investigate the amount of high-intensity exercise needed to improve aerobic capacity and endothelial function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4x4min | Experimental | Other: 1x4 min interval4x4minutes interval group |
| 1x4min | Experimental | Other: 1x4 min interval |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI: 25-30
- Males, 35-45 years
- Healthy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| 1x4 min intervalAerobic interval training | Other | 1x4min, 4x4min |
Primary outcome
Maximal oxygen consumption and endothelial function
Time frame: baseline and 12 weeks followup
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 7 Mar 2014.
- Results publication: PubMed 23734250Tjonna AE, Leinan IM, Bartnes AT, Jenssen BM, Gibala MJ, Winett RA, Wisloff U. Low- and high-volume of intensive endurance training significantly improves maximal oxygen uptake after 10-weeks of training in healthy men. PLoS One. 2013 May 29;8(5):e65382. doi: 10.1371/journal.pone.0065382. Print 2013.
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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.
Arnt E Tjønna, PhD study chair
Norwegian University of Science and Technology
Ulrik Wisløff, PhD principal investigator
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 1x4 min interval in people with Obesity, 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 3 inclusion and 0 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 7 Mar 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 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?
Maximal oxygen consumption and endothelial function (time frame: baseline and 12 weeks followup). 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 NCT00839579, 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 7 Mar 2014; AzTrials last refreshed its copy on 28 Oct 2026.