Morbid ObesityNCT01042002
Effect of Exercise Before Gastric Bypass
A study testing High intensity exercise in people with Morbid 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 20 to 80 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- High intensity exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2006to Oct 2013
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: > 20 years
- BMI: > 40 or > 35 with comorbidity
- Resident: Sør Trøndelag
Who cannot join
- Unstable Angina
- Resent cardiac infarction (within last year)
- heart failure
- Uncontrolled hypertension
- cardiomyopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Exercise Before Gastric bypass-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 aims of this study is to investigate if High-intensity exercise before a gastric bypass operation will decrease hospitalization days and complications after the gastric bypass.
- Conditions
- Morbid Obesity
- Being tested
- High intensity exercise
- Keywords
- High intensity exercise, morbid obesity, gastric bypass
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity exerciseBehavioural
High intensity exercise 3xweek for minimum 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| High intensity exercise | Experimental | Not described Receives: Behavioral: High intensity exercise |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization days after gastric bypass
Measured: Baseline, pre-operation and 6 months post operation
Secondary outcomes (1)
Complications after gastric bypass
Measured: 6 months post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startAug 2006
- Primary completionAug 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 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 Tjonna, PhD, Study chair, Norwegain University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042002
- Sponsor's protocol ID
- AIT and gastric bypass
- Status last verified
- Feb 2017
- First submitted
- 4 Jan 2010
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Before Gastric bypass-a Pilot Study
- ClinicalTrials.gov ID
- NCT01042002
- Acronym / sponsor ID
- AIT and gastric bypass
- Conditions
- Morbid Obesity
- Keywords
- High intensity exercise, morbid obesity, gastric bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Aug 2006 (actual)
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 5 Jan 2010 (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 aims of this study is to investigate if High-intensity exercise before a gastric bypass operation will decrease hospitalization days and complications after the gastric bypass.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity exercise | Experimental | Behavioral: High intensity exercise |
| Control | No intervention | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: > 20 years
- BMI: > 40 or > 35 with comorbidity
- Resident: Sør Trøndelag
Key exclusion criteria (5 listed)
- Unstable Angina
- Resent cardiac infarction (within last year)
- heart failure
- Uncontrolled hypertension
- cardiomyopathy
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 |
|---|---|---|
| High intensity exerciseHigh intensity exercise 3xweek for minimum 6 weeks | Behavioural | High intensity exercise |
Primary outcome
Hospitalization days after gastric bypass
Time frame: Baseline, pre-operation and 6 months post operation
1 secondary outcome
Complications after gastric bypass
Time frame: 6 months post operation
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 23 Feb 2017.
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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 Tjonna, PhD study chair
Norwegain 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 High intensity exercise in people with Morbid 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 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 23 Feb 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?
Hospitalization days after gastric bypass (time frame: Baseline, pre-operation and 6 months post operation). 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 23 Feb 2017; AzTrials last refreshed its copy on 2 Nov 2026.