NCT00875186

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

April 3, 2009

Status Verified

April 1, 2009

Enrollment Period

10 years

First QC Date

April 2, 2009

Last Update Submit

April 2, 2009

Conditions

Morbid Obesity

Keywords

bariatric surgeryco-morbiditiesaerobic physical exercise

Outcome Measures

Primary Outcomes (1)

  • effects of aerobic physical exercising (APE) on weight loss

    10 years

Secondary Outcomes (1)

  • effects of aerobic physical exercising (APE) on co-morbidities

    10 years

Study Arms (2)

multiple-exercise group (ME)

participants exercised 2 times weekly for 1 hour (aerobic endurance training)

Other: aerobic endurance training

Low-exercise group (LE)

participants exercises 1 time weekly for 1 hour (aerobic endurance training)

Other: aerobic endurance training

Interventions

aerobic endurance trainingOTHER

participants exercises 2 times weekly for 1 hour (aerobic endurance training)

Also known as: aerobic physical exercise
multiple-exercise group (ME)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Obesity WHO III

You may not qualify if:

  • Contraindications of aerobic endurance training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, University Hospital Mannheim

Mannheim, 68167, Germany

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Exercise

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Edward Shang, M.D.

    Universitätsmedizin Mannheim

    STUDY CHAIR

  • Till Hasenberg, M.D.

    Universitätsmedizin Mannheim

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward Shang, M.D.

CONTACT

+49-621-383-2756edward.shang@umm.de

Till Hasenberg, M.D.

CONTACT

+49-621-383-3342till.hasenberg@umm.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 2, 2009

First Posted

April 3, 2009

Study Start

October 1, 2006

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

April 3, 2009

Record last verified: 2009-04

Locations

DE(1)