Effect of Physical Activity on Weight Loss and Cardiovascular Risk Factors After Gastric Bypass
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01690728|
Recruitment Status : Completed
First Posted : September 24, 2012
Last Update Posted : March 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity Inactivity||Behavioral: Physical Activity||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Physical Activity on Weight Loss and Cardiovascular Risk Factors After Gastric Bypass|
|Actual Study Start Date :||October 2012|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||November 2016|
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690728
|Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Denmark|
|Esbjerg, Denmark, 6700|
|Principal Investigator:||Claus B Juhl, MD, ph.d.||Hospital of South West Denmark|