Morbid ObesityAETNCT00875186
The Influence of Aerobic Endurance Training After Roux-en-Y-Gastric Bypass
An observational study of Morbid Obesity, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
The aim of this study was to assess the efficiency of aerobic physical exercise (APE) on weight loss, body composition and co-morbidities in patients after laparoscopic Roux-en-Y Gastric bypass (RYGBP). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- aerobic endurance training
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to Oct 2016
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: morbidly obese patients underwent laparoscopic Roux-en-Y gastric bypass as a primary procedure for morbid obesity
Who may be able to join
- Obesity WHO III
Who cannot join
- Contraindications of aerobic endurance training
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Surgery, University Hospital Mannheim
Mannheim, 68167
Edward Shang, M.D.
Till Hasenberg, M.D.
About this study
Official title: Impact of Aerobic Physical Exercising on Body Composition and co-Morbidities in Patients After Laparoscopic Roux-en-Y Gastric Bypass
The aim of this study was to assess the efficiency of aerobic physical exercise (APE) on weight loss, body composition and co-morbidities in patients after laparoscopic Roux-en-Y Gastric bypass (RYGBP).
Read the detailed description
The only effective treatment for patients with morbid obesity is bariatric surgery. Sudden weight loss following bariatric operations for morbid obesity, such as Roux-en-Y gastric bypass (RYGBP) can result in a concurrent decrease in lean body mass. However the long-time results (weight reduction, elimination co-morbidities) are depending on the post operative treatment. Aerobic physical exercising (APE) is well accepted in conservative treatment of obesity as well as of diabetes mellitus type 2 (DM). The aim of this study was to assess the efficiency of APE on weight loss, body composition and co-morbidities in patients after laparoscopic Roux-en-Y Gastric bypass (RYGBP).
- Conditions
- Morbid Obesity
- Being tested
- aerobic endurance training
- Keywords
- bariatric surgery, co-morbidities, aerobic physical exercise
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic endurance trainingOther
Also called aerobic physical exercise
participants exercises 2 times weekly for 1 hour (aerobic endurance training)
aerobic endurance trainingOther
Also called aerobic physical exercise
participants exercised 1 time weekly for 1 hour (aerobic endurance training)
| Study group | Role | What they receive |
|---|---|---|
| multiple-exercise group (ME) | participants exercised 2 times weekly for 1 hour (aerobic endurance training) Receives: Other: aerobic endurance training | |
| Low-exercise group (LE) | participants exercises 1 time weekly for 1 hour (aerobic endurance training) Receives: Other: aerobic endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
effects of aerobic physical exercising (APE) on weight loss
Measured: 10 years
Secondary outcomes (1)
effects of aerobic physical exercising (APE) on co-morbidities
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startOct 2006
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Investigators
- Edward Shang, M.D., Study chair, Universitätsmedizin MannheimTill Hasenberg, M.D., Principal investigator, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875186
- Sponsor's protocol ID
- AET 1
- Acronym
- AET
- Status last verified
- Apr 2009
- First submitted
- 2 Apr 2009
- Last updated
- 3 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aerobic Physical Exercising on Body Composition and co-Morbidities in Patients After Laparoscopic Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT00875186
- Acronym / sponsor ID
- AET / AET 1
- Conditions
- Morbid Obesity
- Keywords
- bariatric surgery, co-morbidities, aerobic physical exercise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 3 Apr 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 aim of this study was to assess the efficiency of aerobic physical exercise (APE) on weight loss, body composition and co-morbidities in patients after laparoscopic Roux-en-Y Gastric bypass (RYGBP).
Detailed description
The only effective treatment for patients with morbid obesity is bariatric surgery. Sudden weight loss following bariatric operations for morbid obesity, such as Roux-en-Y gastric bypass (RYGBP) can result in a concurrent decrease in lean body mass. However the long-time results (weight reduction, elimination co-morbidities) are depending on the post operative treatment. Aerobic physical exercising (APE) is well accepted in conservative treatment of obesity as well as of diabetes mellitus type 2 (DM). The aim of this study was to assess the efficiency of APE on weight loss, body composition and co-morbidities in patients after laparoscopic Roux-en-Y Gastric bypass (RYGBP).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multiple-exercise group (ME) | – | Other: aerobic endurance trainingparticipants exercised 2 times weekly for 1 hour (aerobic endurance training) |
| Low-exercise group (LE) | – | Other: aerobic endurance trainingparticipants exercises 1 time weekly for 1 hour (aerobic endurance training) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- morbidly obese patients underwent laparoscopic Roux-en-Y gastric bypass as a primary procedure for morbid obesity
Key inclusion criteria (1 listed)
- Obesity WHO III
Key exclusion criteria (1 listed)
- Contraindications of aerobic endurance training
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 endurance trainingAlso: aerobic physical exerciseparticipants exercises 2 times weekly for 1 hour (aerobic endurance training) | Other | multiple-exercise group (ME) |
| aerobic endurance trainingAlso: aerobic physical exerciseparticipants exercised 1 time weekly for 1 hour (aerobic endurance training) | Other | Low-exercise group (LE) |
Primary outcome
effects of aerobic physical exercising (APE) on weight loss
Time frame: 10 years
1 secondary outcome
effects of aerobic physical exercising (APE) on co-morbidities
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2009.
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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.
Edward Shang, M.D. study chair
Universitätsmedizin Mannheim
Till Hasenberg, M.D. principal investigator
Universitätsmedizin Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by Universitätsmedizin Mannheim at 1 site in Germany.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Apr 2009. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edward Shang, M.D. (+49-621-383-2756, edward.shang@umm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effects of aerobic physical exercising (APE) on weight loss (time frame: 10 years). 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 3 Apr 2009.