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Effect of Exercise Before Gastric Bypass

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01042002
First received: January 4, 2010
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Morbid Obesity
Behavioral: High intensity exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Exercise Before Gastric bypass-a Pilot Study

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Hospitalization days after gastric bypass [ Time Frame: Baseline, pre-operation and 6 months post operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications after gastric bypass [ Time Frame: 6 months post operation ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: August 2006
Study Completion Date: October 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High intensity exercise Behavioral: High intensity exercise
High intensity exercise 3xweek for minimum 6 weeks
No Intervention: Control

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01042002

Locations
Norway
Norwegian University of Science and Technology
Trondheim, Norway, 7489
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Study Chair: Arnt E Tjonna, PhD Norwegain University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01042002     History of Changes
Other Study ID Numbers: AIT and gastric bypass
Study First Received: January 4, 2010
Last Updated: November 26, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
High intensity exercise
morbid obesity
gastric bypass

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

ClinicalTrials.gov processed this record on November 27, 2014