NCT01042002

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2006

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

6 years

First QC Date

January 4, 2010

Last Update Submit

February 21, 2017

Conditions

Morbid Obesity

Keywords

High intensity exercisemorbid obesitygastric bypass

Outcome Measures

Primary Outcomes (1)

  • Hospitalization days after gastric bypass

    Baseline, pre-operation and 6 months post operation

Secondary Outcomes (1)

  • Complications after gastric bypass

    6 months post operation

Study Arms (2)

High intensity exercise

EXPERIMENTAL
Behavioral: High intensity exercise

Control

NO INTERVENTION

Interventions

High intensity exerciseBEHAVIORAL

High intensity exercise 3xweek for minimum 6 weeks

High intensity exercise

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, 7489, Norway

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Arnt E Tjonna, PhD

    Norwegain University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 5, 2010

Study Start

August 1, 2006

Primary Completion

August 1, 2012

Study Completion

October 1, 2013

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

NO(1)