Effect of Physical Activity on Weight Loss & Cardiovascular Risk Factors

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01690728
Study type	Interventional
Source	Hospital of South West Jutland
Contact
Status	Completed
Phase	N/A
Start date	October 2012
Completion date	November 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms