- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00875186
The Influence of Aerobic Endurance Training After Roux-en-Y-Gastric Bypass (AET)
April 2, 2009 updated by: Universitätsmedizin Mannheim
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Edward Shang, M.D.
- Phone Number: +49-621-383-2756
- Email: edward.shang@umm.de
Study Contact Backup
- Name: Till Hasenberg, M.D.
- Phone Number: +49-621-383-3342
- Email: till.hasenberg@umm.de
Study Locations
-
-
-
Mannheim, Germany, 68167
- Recruiting
- Department of Surgery, University Hospital Mannheim
-
Principal Investigator:
- Edward Shang, M.D.
-
Principal Investigator:
- Till Hasenberg, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
morbidly obese patients underwent laparoscopic Roux-en-Y gastric bypass as a primary procedure for morbid obesity
Description
Inclusion Criteria:
- Obesity WHO III
Exclusion Criteria:
- Contraindications of aerobic endurance training
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
multiple-exercise group (ME)
participants exercised 2 times weekly for 1 hour (aerobic endurance training)
|
participants exercises 2 times weekly for 1 hour (aerobic endurance training)
Other Names:
participants exercised 1 time weekly for 1 hour (aerobic endurance training)
Other Names:
|
Low-exercise group (LE)
participants exercises 1 time weekly for 1 hour (aerobic endurance training)
|
participants exercises 2 times weekly for 1 hour (aerobic endurance training)
Other Names:
participants exercised 1 time weekly for 1 hour (aerobic endurance training)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
effects of aerobic physical exercising (APE) on weight loss
Time Frame: 10 years
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
effects of aerobic physical exercising (APE) on co-morbidities
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Edward Shang, M.D., Universitätsmedizin Mannheim
- Principal Investigator: Till Hasenberg, M.D., Universitätsmedizin Mannheim
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Anticipated)
October 1, 2016
Study Completion (Anticipated)
October 1, 2016
Study Registration Dates
First Submitted
April 2, 2009
First Submitted That Met QC Criteria
April 2, 2009
First Posted (Estimate)
April 3, 2009
Study Record Updates
Last Update Posted (Estimate)
April 3, 2009
Last Update Submitted That Met QC Criteria
April 2, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AET 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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