Physical Activity and Protein Supplementation After Bariatric Surgery (PAPAB)
- Conditions
- Bariatric Surgery Candidate
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: ProteinBehavioral: Computer-assisted exerciseBehavioral: Usual exercise
- Registration Number
- NCT02128698
- Lead Sponsor
- University of Hohenheim
- Brief Summary
The purpose of this study is to determine wether regular physical activity in combination with protein supplementation after bariatric surgery can reduce the loss of muscle mass and wether a computer-assisted exercise program is more effective than a usual exercise program regarding frequency of physical activity, fitness and muscular strength.
- Detailed Description
Bariatric surgery has become a major treatment option for severe obesity in adults. Despite the advantages of bariatric surgery, attention needs to be paid to the possible risks following the surgical treatment. Postoperative risks include protein deficiency and pronounced muscle mass loss. Indeed, numerous studies indicate a significant reduction in lean body mass resulting from protein deficiency after bariatric surgery.
Dietary proteins have shown to play an important role in body weight regulation. A protein-rich diet attains satiety and thereby facilitates reduction in overall energy intake. It has also shown to enhance food-induced thermogenesis. Furthermore, a protein-rich diet - ideally in combination with exercise - preserves lean body mass and thus resting energy expenditure leading to an improvement of long-term energy balance. Therefore, protein-rich diets or protein supplements, respectively, might facilitate weight loss, especially body fat loss and protect against loss in muscle mass in patients who underwent bariatric surgery. The aim of the present randomized, placebo-controlled, double blind pilot study was to test the possible benefit of proteins in combination with exercise in patients undergoing bariatric surgery, and to examine, whether computer-assisted exercise is advantageous when comparing it to a usual exercise program using written exercise instructions. Therefore, we study the influence of postoperative protein supplementation in combination with computer-assisted exercise on body composition changes, and body weight reduction, as well as physical fitness, protein status and muscle function in obese patients after bariatric surgery.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Age of 18 - 65 years
- Body weight of ≤ 150 kg
- BMI > 35 kg/m2
- Indication for laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass. The decision about the type of surgery is performed independent of the study by the surgeons in charge according to the German S3 guideline.
- Kidney diseases of any kind
- Serious gastrointestinal diseases (e.g. Morbus Crohn, Colitis Ulcerosa, etc.)
- Serious musculoskeletal diseases
- Serious heart diseases (Myocardial infarction, stent implantation, stroke, etc.)
- Intake of blood thinning medicine (e.g. ASS, Marcumar, etc.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo and computer-assisted exercise Placebo Patient group which takes daily control product and is advised to do exercise 4 times per week by using Nintendo Wii Balance Board and Wii Fit Plus Software during 6 months after bariatric surgery. Protein and computer-assisted exercise Computer-assisted exercise Patient group which takes daily protein supplements and is advised to do exercise 4 times per week by using Nintendo Wii Balance Board and Wii Fit Plus Software during 6 months after bariatric surgery. Placebo and usual exercise Placebo Patient group which takes daily control product and is advised to do exercise 4 times per week by using written exercise instructions during 6 months after bariatric surgery. Placebo and usual exercise Usual exercise Patient group which takes daily control product and is advised to do exercise 4 times per week by using written exercise instructions during 6 months after bariatric surgery. Protein and usual exercise Usual exercise Patient group which takes daily protein supplements and is advised to do exercise 4 times per week by using written exercise instructions during 6 months after bariatric surgery. Placebo and computer-assisted exercise Computer-assisted exercise Patient group which takes daily control product and is advised to do exercise 4 times per week by using Nintendo Wii Balance Board and Wii Fit Plus Software during 6 months after bariatric surgery. Protein and usual exercise Protein Patient group which takes daily protein supplements and is advised to do exercise 4 times per week by using written exercise instructions during 6 months after bariatric surgery. Protein and computer-assisted exercise Protein Patient group which takes daily protein supplements and is advised to do exercise 4 times per week by using Nintendo Wii Balance Board and Wii Fit Plus Software during 6 months after bariatric surgery.
- Primary Outcome Measures
Name Time Method Lean body mass loss expressed as percentage of weight loss [%] At month 6 Lean body mass is measured by using body impedance analysis. The content of lean body mass in lost weight is calculated using the lost weight in kg and the lost lean body mass in kg.
- Secondary Outcome Measures
Name Time Method Relative weight loss [%] At month 6 Grip strength endurance [sec] At month 6 Grip strength endurance \[sec\] is measured by using a hydraulic force measuring device.
Physical fitness [repetitions per 30 sec] / [distance in meters] At month 6 Physical fitness is assessed by the "30 Second Sit to Stand Test" and the "6 Minute Walk Test (6MWT)". The results of these tests are stated as repetitions per 30 seconds, and distance in meters, respectively.
Grip strength [lb] At month 6 Grip strength \[lb\] is measured by using a hydraulic force measuring device.
Trial Locations
- Locations (1)
Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen
🇩🇪Tübingen, Germany