Effect of Physical Activity on Weight Loss and Cardiovascular Risk Factors After Gastric Bypass
Condition: Morbid Obesity; Inactivity
MeSH terms: Obesity, Morbid; Weight Loss
Study type: Interventional

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.
    

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.
    

Intervention name(s): Physical Activity
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Obesity; Gastric bypass