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| Name | Class |
|---|---|
| University Hospital Tuebingen | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protein and computer-assisted exercise | Experimental | 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. |
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| Placebo and computer-assisted exercise | Placebo Comparator | 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. |
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| Protein and usual exercise | Active Comparator | 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. |
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| Placebo and usual exercise | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein | Dietary Supplement | Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively. |
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| Measure | Description | Time Frame |
|---|---|---|
| Lean body mass loss expressed as percentage of weight loss [%] | 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. | At month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Relative weight loss [%] | At month 6 | |
| Grip strength [lb] | Grip strength [lb] is measured by using a hydraulic force measuring device. | At month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood proteins | Blood proteins, including albumin, prealbumin, transferrin, and total protein, are measured to assess blood protein status. | At month 6 |
| Urea and creatinine excretion | Urea and creatinine excretion are measured in 24 h urine samples. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfred Königsrainer, Professor | Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen, Tübingen, Germany | Study Director |
| Tobias Meile, MD | Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen, Tübingen, Germany | Principal Investigator |
| Stephan C Bischoff, Professor | Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General, Visceral, and Transplant Surgery, University Hospital of Tübingen | Tübingen | 72076 | Germany |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D011506 | Proteins |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
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| Placebo | Dietary Supplement | Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively. |
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| Computer-assisted exercise | Behavioral | 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. |
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| Usual exercise | Behavioral | Postoperative regular exercise using written exercise instructions. Exercise is advised to be done 4 times per week. |
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| Grip strength endurance [sec] | Grip strength endurance [sec] is measured by using a hydraulic force measuring device. | At month 6 |
| Physical fitness [repetitions per 30 sec] / [distance in meters] | 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. | At month 6 |
| At month 6 |
| Frequency of exercise | The frequency of exercise is assessed by using heart rate monitors, which are able to save all exercise data of the patients. | During the whole study period of 6 months |
| Health related quality of life | Health related quality of life is assessed by using the standardized questionnaire "short form 36" (SF36). | At month 6 |
| Body weight related quality of life | Body weight related quality of life is assessed by using the standardized questionnaire "Impact of Weight on Quality of Life" (IWQOL). | At month 6 |
| Outcome after bariatric surgery | 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. | At month 6 |
| Anxiety disorder | Anxiety is assessed by using the standardized questionnaire "Generalised Anxiety Disorder Assessment" (GAD7). | At month 6 |
| Mental health | Mental health is assessed by using the standardized questionnaire "Patient Health Questionnaire" (PHQ9). | At month 6 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |