Effect of Physical Activity on Weight Loss and Cardiovascular Risk Factors After Gastric Bypass

October 18, 2022 updated by: Lene Hymøller Mundbjerg, Hospital of South West Jutland
The aim of this study is to increase our knowledge about the effect of physical activity in patients who have undergone gastric bypass surgery. The study will provide novel information in two areas. The main objective is to study the effect of physical activity on the weight loss and cardiovascular risk factors. This will be accomplished in a randomized clinical trial in patients, who are eligible for gastric bypass (GB). Patients will be randomized to six month of structured physical activity or standard postoperative counseling. The study will include an exhaustive panel of blood tests related to cardiovascular risk and the most extensive evaluation of structural and functional vascular test done in this patient group so far. In addition the study will provide information of the effect of bariatric surgery per se since both pre- and postoperative investigations are conducted. The study will learn us to what degree it is possible to motivate this group of patients to increased physical activity. All together this will enable us to improve the counseling of the patients undergoing GB.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted as a prospective, randomized, controlled, two-group, intervention study. Patients will be recruited among individuals referred to the tertiary center for bariatric surgery. The patients will be asked to participate in the study when they attend the preoperative education for bariatric surgery. Randomization will be performed in blocks ensuring an equal distribution of type 2 diabetes patients in the two study groups.

Participants will be investigated before gastric bypass surgery, six, 12 and 24 month post-operative. Intervention, consisting of structured physical activity will take place from six to 12 month after operation.

The intervention program will continue for six month. The supervised exercise program will take place at the training center consisting of 40 min. sessions two times pr. week for 26 consecutive weeks.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Esbjerg, Denmark, 6700
        • Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 25 - 60 years
  • Able to understand and cooperate with the interventions in the study
  • Eligible for gastric bypass surgery

Exclusion Criteria:

  • Inability to perform physical activity at the intensity and quantity required in the study, such as physical disabled patients including severe osteoarthritis
  • Use of vitamin K antagonists, oral contraceptives, or hormone replacement therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Physical Activity
40 min exercise supervised by physiotherapists two times weekly in six month.
Behavioral: Physical Activity
The intervention program will continue for six month consisting of two weekly sessions of 40 min exercise supervised by physiotherapists. The supervised exercise program will take place at the training center Fitness.dk in Esbjerg and Kolding. It will be in cooperation with physiotherapists at the Therapy Department of Sydvestjysk Sygehus Esbjerg and the Therapy Department of Fredericia and Kolding Sygehus, Sygehus Lillebælt. The exercise program at the two centers will be equal. In addition the patients will be provided with free access to a fitness center. The patient will be encouraged to do at least 3.5 hours of moderate to vigorous physical activity per week.
No Intervention: Control Group
These participants follows the standard post surgery follow-up consisting of counseling by dietitians, nurses and doctors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: Measures 1-2 weeks before gastric bypass, change from baseline 6, 12 and 24 month post-surgery
The participants pre-operative weight are measured before gastric bypass surgery. This measure will take place within 2 weeks before surgery. Weight change from baseline will be measured 6, 12 and 24 months post-surgery.
Measures 1-2 weeks before gastric bypass, change from baseline 6, 12 and 24 month post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood tests
Time Frame: Measures 1-2 weeks before gastric bypass, 6, 12 and 24 month post-surgery
Exhaustive panel of blood tests related to cardiovascular risk. The participants are measured before gastric bypass surgery. This measure will take place within 2 weeks before surgery. Changes in blood analyses from baseline will be measured 6, 12 and 24 months post-surgery.
Measures 1-2 weeks before gastric bypass, 6, 12 and 24 month post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital of South West Jutland

Investigators

  • Principal Investigator: Claus B Juhl, MD, ph.d., Hospital of South West Jutland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

September 14, 2012

First Submitted That Met QC Criteria

September 19, 2012

First Posted (Estimate)

September 24, 2012

Study Record Updates

Last Update Posted (Actual)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBR-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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