Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen
Tübingen, 72076, Germany
NCT Number: NCT02128698
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Tübingen, 72076, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.
Other names: Resource Instant Protein 88, Néstle Health Nutrition
Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.
Other names: Resource Maltodextrin, Néstle Health Nutrition
Postoperative regular computer-assisted exercise using Nintendo Wii Mini, Nintendo Wii Balance Board and Wii Fit Plus Software. Exercise is advised to be done 4 times per week.
Postoperative regular exercise using written exercise instructions. Exercise is advised to be done 4 times per week.
Time frame: 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.
Time frame: At month 6
Time frame: At month 6
Grip strength [lb] is measured by using a hydraulic force measuring device.
Time frame: At month 6
Grip strength endurance [sec] is measured by using a hydraulic force measuring device.
Time frame: 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.
Time frame: At month 6
Blood proteins, including albumin, prealbumin, transferrin, and total protein, are measured to assess blood protein status.
Time frame: At month 6
Urea and creatinine excretion are measured in 24 h urine samples.
Time frame: During the whole study period of 6 months
The frequency of exercise is assessed by using heart rate monitors, which are able to save all exercise data of the patients.
Time frame: At month 6
Health related quality of life is assessed by using the standardized questionnaire "short form 36" (SF36).
Time frame: At month 6
Body weight related quality of life is assessed by using the standardized questionnaire "Impact of Weight on Quality of Life" (IWQOL).
Time frame: At month 6
Outcome is measured by using the standardized instrument "Bariatric Analysis and Reporting Outcome System" (BAROS) which considers excess weight loss, improvement of obesity-related comorbidities, and health related quality of life.
Time frame: At month 6
Anxiety is assessed by using the standardized questionnaire "Generalised Anxiety Disorder Assessment" (GAD7).
Time frame: At month 6
Mental health is assessed by using the standardized questionnaire "Patient Health Questionnaire" (PHQ9).
University of Hohenheim
Other
Physical Activity and Protein Supplementation After Bariatric Surgery
Acronym: PAPAB
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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