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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2009 by Universitätsmedizin Mannheim
Sponsor:
Information provided by:
Universitätsmedizin 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:


Further study details as provided by Universitätsmedizin 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Universitätsmedizin Mannheim
Investigators
Study Chair: Edward Shang, M.D. Universitätsmedizin Mannheim
Principal Investigator: Till Hasenberg, M.D. Universitätsmedizin 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 Universitätsmedizin 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 July 26, 2014