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Effect of Exercise Before Gastric Bypass

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
High intensity exercise
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Morbid Obesity focused on measuring High intensity exercise, morbid obesity, gastric bypass

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: > 20 years
  • BMI: > 40 or > 35 with comorbidity
  • Resident: Sør Trøndelag

Exclusion Criteria:

  • Unstable Angina
  • Resent cardiac infarction (within last year)
  • heart failure
  • Uncontrolled hypertension
  • cardiomyopathy

Sites / Locations

  • Norwegian University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

High intensity exercise

Control

Arm Description

Outcomes

Primary Outcome Measures

Hospitalization days after gastric bypass

Secondary Outcome Measures

Complications after gastric bypass

Full Information

First Posted
January 4, 2010
Last Updated
February 21, 2017
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01042002
Brief Title
Effect of Exercise Before Gastric Bypass
Official Title
Effect of Exercise Before Gastric bypass-a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2006 (Actual)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Exercise training is proved to protect against premature cardiovascular mortality. Additionally there is evidence that relatively high exercise intensity may be an important factor for improving aerobic capacity and endothelial function in patients with post-infarction heart failure, metabolic syndrome, coronary artery disease, as well as in overweight and obese individuals. The aims of this study is to investigate if High-intensity exercise before a gastric bypass operation will decrease hospitalization days and complications after the gastric bypass.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
High intensity exercise, morbid obesity, gastric bypass

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High intensity exercise
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
High intensity exercise
Intervention Description
High intensity exercise 3xweek for minimum 6 weeks
Primary Outcome Measure Information:
Title
Hospitalization days after gastric bypass
Time Frame
Baseline, pre-operation and 6 months post operation
Secondary Outcome Measure Information:
Title
Complications after gastric bypass
Time Frame
6 months post operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: > 20 years BMI: > 40 or > 35 with comorbidity Resident: Sør Trøndelag Exclusion Criteria: Unstable Angina Resent cardiac infarction (within last year) heart failure Uncontrolled hypertension cardiomyopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnt E Tjonna, PhD
Organizational Affiliation
Norwegain University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Norwegian University of Science and Technology
City
Trondheim
ZIP/Postal Code
7489
Country
Norway

12. IPD Sharing Statement

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Effect of Exercise Before Gastric Bypass

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