Effect of Exercise Before Gastric Bypass | NCT01042002

Studies
Effect of Exercise Before Gastric Bypass

NCT01042002

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

43Actual

Phase

Not Applicable

Conditions

Morbid Obesity

Interventions

High intensity exercise

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006Actual

Primary Completion Date

Aug 2012Actual

Completion Date

Oct 2013Actual

First Submitted Date

Jan 4, 2010

First Submission Date that Met QC Criteria

Jan 4, 2010

First Posted Date

Jan 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2017

Last Update Posted Date

Feb 23, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High intensity exercise	Experimental		Behavioral: High intensity exercise
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High intensity exercise	Behavioral	High intensity exercise 3xweek for minimum 6 weeks	High intensity exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospitalization days after gastric bypass		Baseline, pre-operation and 6 months post operation

Secondary Outcomes

Measure	Description	Time Frame
Complications after gastric bypass		6 months post operation

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arnt E Tjonna, PhD	Norwegain University of Science and Technology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Norwegian University of Science and Technology		Trondheim		7489	Norway

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000072696	High-Intensity Interval Training

Ancestor Terms

ID	Term
D064797	Physical Conditioning, Human
D015444	Exercise
D009043	Motor Activity
D009068	Movement

Browse Leaves

Not provided

Browse Branches

Not provided