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The Influence of Aerobic Endurance Training After Roux-en-Y-Gastric Bypass (AET)

This study is currently recruiting participants.
Verified April 2009 by University Hospital Mannheim
Sponsor:
Information provided by:
University Hospital Mannheim
ClinicalTrials.gov Identifier:
NCT00875186
First received: April 2, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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).


Condition Intervention
Morbid Obesity
 Other: aerobic endurance training

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Impact of Aerobic Physical Exercising on Body Composition and co-Morbidities in Patients After Laparoscopic Roux-en-Y Gastric Bypass

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Mannheim:

Primary Outcome Measures:
  • effects of aerobic physical exercising (APE) on weight loss [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • effects of aerobic physical exercising (APE) on co-morbidities [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2006
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
multiple-exercise group (ME)
participants exercised 2 times weekly for 1 hour (aerobic endurance training)
 Other: aerobic endurance training
participants exercises 2 times weekly for 1 hour (aerobic endurance training)
Other Name: aerobic physical exercise
Low-exercise group (LE)
participants exercises 1 time weekly for 1 hour (aerobic endurance training)
 Other: aerobic endurance training
participants exercised 1 time weekly for 1 hour (aerobic endurance training)
Other Name: aerobic physical exercise

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

morbidly obese patients underwent laparoscopic Roux-en-Y gastric bypass as a primary procedure for morbid obesity

Criteria

Inclusion Criteria:

  • Obesity WHO III

Exclusion Criteria:

  • Contraindications of aerobic endurance training
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875186

Contacts
Contact: Edward Shang, M.D. +49-621-383-2756 edward.shang@umm.de
Contact: Till Hasenberg, M.D. +49-621-383-3342 till.hasenberg@umm.de

Locations
Germany
Department of Surgery, University Hospital Mannheim Recruiting
Mannheim, Germany, 68167
Principal Investigator: Edward Shang, M.D.            
Principal Investigator: Till Hasenberg, M.D.            
Sponsors and Collaborators
University Hospital Mannheim
Investigators
Study Chair: Edward Shang, M.D. University Hospital Mannheim
Principal Investigator: Till Hasenberg, M.D. University Hospital Mannheim
  More Information

No publications provided

Responsible Party: Assoc. Professor Edward Shang, MD, Department of Surgery, University Hospital Mannheim
ClinicalTrials.gov Identifier: NCT00875186     History of Changes
Other Study ID Numbers: AET 1
Study First Received: April 2, 2009
Last Updated: April 2, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Mannheim:
bariatric surgery
co-morbidities
aerobic physical exercise

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013