Effect of Physical Activity on Weight Loss and Cardiovascular Risk Factors After Gastric Bypass
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Effect of Physical Activity on Weight Loss and Cardiovascular Risk Factors After Gastric Bypass|
- Weight loss [ Time Frame: Measures 1-2 weeks before gastric bypass, change from baseline 6, 12 and 24 month post-surgery ] [ Designated as safety issue: Yes ]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.
- Blood tests [ Time Frame: Measures 1-2 weeks before gastric bypass, 6, 12 and 24 month post-surgery ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690728
|Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Denmark|
|Esbjerg, Denmark, 6700|