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| Name | Class |
|---|---|
| University of Erlangen-Nürnberg Institute of Medical Physics | UNKNOWN |
| University of Erlangen-Nürnberg Institute of Biomedicine of Aging | UNKNOWN |
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The aim of the study is to determine the effect of 16 weeks of Whole Body-Electromyostimulation (WB-EMS) and/or protein supplementation on Sarcopenic Obesity (SO) in community dwelling male subjects 70+ with SO .
108 eligible men will be randomly assigned to either a (1) WB-EMS and Protein (2) Protein (3) sedentary control group.
WB-EMS will be applied 1,5 x 20 min per week (i.e. 3 sessions in two weeks) with bipolar current, 85 Hz in an intermitted mode (4 s - 4 s of rest). Protein supplementation will be adjusted to dietary intake in order to reach a total protein intake between 1,5 - 1,7g/kg body-mass/d . Primary study endpoint will be the Sarcopenia Z-Score
The aim of the study is to evaluate the effects of Whole-Body Electromyostimulation (WB-EMS) with additional protein supplementation on Sarcopenic Obesity parameters in independently living men 70 years and older with sarcopenic obesity. The randomized controlled study compares three groups with 36 subjects each: (1) WB-EMS with additional protein supplementation, (2) protein-only and (3) passive control group, over a period of 16 weeks of WB-EMS -training. Group (1) conducts 1.5-times/week a 20 minute-sessions of WB-EMS with additional protein, group (2) is limited to protein supplementation (only) and group (3) is constrained to maintain their habitual living behavior and physical activity. Based on an individual nutrition analysis the protein intake will be adjusted to 1.5-1.7 g/kg/ bodymass/d. All groups will be supplemented with a maximum of 800 IE Vitamin D.
Primary study endpoint will be changes of the Sarcopenia Z-Score with skeletal muscle mass assessed via bio-impedance analysis (BIA). Secondary study endpoints are changes of Obesity (i.e. body-fat as assessed via BIA), cardiometabolic risk (i.e. Metabolic Syndrome Z-Score), strength parameters evaluated via Dr. Wolff BackCheck and Physiomed LegPress, quality of life (SF-12) and functional disability (late life physical disability index).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole-Body Electromyostimulation and Protein | Experimental | 16 weeks of whole-body intervention 1.5 x 20 min week with bipolar current up to 1.5 - 1.7 g/kg body mass/d of protein supplements up to 800 IU/d Vitamin D-Supplementation |
|
| Protein supplementation | Active Comparator | up to 1.5 - 1.7 g/kg body mass/d of protein supplements up to 800 IU/d Vitamin D-Supplementation |
|
| sedentary Control Group | No Intervention | No protein supplementation or WB-EMS-application, but up to 800 IU/d Vitamin D-Supplementation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole body Electromyostimulation (exercise) | Other | 1.5 x 20 min/week (e.g. each Tuesday and every second Friday) with bipolar current, 85 Hz, 360 µs, rectangular mode, intermittent with 4 sec of current and 4 s of rest. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Sarcopenia Z-Score | ie. Z-Score generated by skeletal muscle index, gait speed and grip-strength according to the Sarcopenia Definition of the European Working Group on Sarcopenia in Older People | Change from Baseline Sarcopenia Z-Score at 16 weeks |
| Change of Obesity | Assessment of body fat content and body mass index | Change from Baseline Obesity at 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Metabolic Syndrome Z-Score | Metabolic Syndrome according to the International Diabetes Federation (IDF) | Change from Baseline Metabolic Syndrome Z-Score at 16 weeks |
| Change of isokinetic leg strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cornel Sieber, MD | Institute of Biomedicine of Aging, University of Erlangen-Nürnberg | Study Chair |
| Klaus Engelke, PhD | University of Erlangen-Nürnberg Medical School | Study Chair |
| Ellen Freiberger, PhD | Institute of Biomedicine of Aging, University of Erlangen-Nürnberg | Study Chair |
| Anja Weissenfels, MA | University of Erlangen-Nürnberg Medical School | Principal Investigator |
| Wolfgang Kemmler, PhD | University of Erlangen-Nürnberg Medical School | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg | Erlangen | Bavaria | 91052 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27289534 | Background | Kemmler W, Teschler M, Weissenfels A, Bebenek M, von Stengel S, Kohl M, Freiberger E, Goisser S, Jakob F, Sieber C, Engelke K. Whole-body electromyostimulation to fight sarcopenic obesity in community-dwelling older women at risk. Resultsof the randomized controlled FORMOsA-sarcopenic obesity study. Osteoporos Int. 2016 Nov;27(11):3261-3270. doi: 10.1007/s00198-016-3662-z. Epub 2016 Jun 12. | |
| 26491272 |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D011506 | Proteins |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Protein | Dietary Supplement | up to 1.5-1.7 g/kg bodymass/d of protein (whey protein) |
|
Dynamic strength of the leg extensors and flexors as determined by a isokinetic leg press
| Change from Baseline isokinetic leg strength at 16 weeks |
| Change of Quality of Life | Quality of life as determined by the SF-12 questionnaire | Change from Baseline Quality of life at 16 weeks |
| Change of Physical Disability | Physical disability as assessed by Late Life Functional and Disability Index (LLFDI) | Change from Baseline Physical Disability at 16 weeks |
| Change of Back Extensors Strength | Strength of the back extensors and flexors using the Doctor Wolff Backcheck device | Change from Baseline Back Extensors Strength at 16 weeks |
| Background |
| Kemmler W, Teschler M, Goisser S, Bebenek M, von Stengel S, Bollheimer LC, Sieber CC, Freiberger E. Prevalence of sarcopenia in Germany and the corresponding effect of osteoarthritis in females 70 years and older living in the community: results of the FORMoSA study. Clin Interv Aging. 2015 Oct 3;10:1565-73. doi: 10.2147/CIA.S89585. eCollection 2015. |
| 26318759 | Background | Kemmler W, von Stengel S, Engelke K, Sieber C, Freiberger E. Prevalence of sarcopenic obesity in Germany using established definitions: Baseline data of the FORMOsA study. Osteoporos Int. 2016 Jan;27(1):275-81. doi: 10.1007/s00198-015-3303-y. Epub 2015 Aug 29. |
| 26346071 | Background | Goisser S, Kemmler W, Porzel S, Volkert D, Sieber CC, Bollheimer LC, Freiberger E. Sarcopenic obesity and complex interventions with nutrition and exercise in community-dwelling older persons--a narrative review. Clin Interv Aging. 2015 Aug 6;10:1267-82. doi: 10.2147/CIA.S82454. eCollection 2015. |
| 32761398 | Derived | Chaudry O, Friedberger A, Grimm A, Uder M, Nagel AM, Kemmler W, Engelke K. Segmentation of the fascia lata and reproducible quantification of intermuscular adipose tissue (IMAT) of the thigh. MAGMA. 2021 Jun;34(3):367-376. doi: 10.1007/s10334-020-00878-w. Epub 2020 Aug 6. |
| 29675640 | Derived | Kemmler W, Grimm A, Bebenek M, Kohl M, von Stengel S. Effects of Combined Whole-Body Electromyostimulation and Protein Supplementation on Local and Overall Muscle/Fat Distribution in Older Men with Sarcopenic Obesity: The Randomized Controlled Franconia Sarcopenic Obesity (FranSO) Study. Calcif Tissue Int. 2018 Sep;103(3):266-277. doi: 10.1007/s00223-018-0424-2. Epub 2018 Apr 19. |
| 29523089 | Derived | Kemmler W, Kohl M, Freiberger E, Sieber C, von Stengel S. Effect of whole-body electromyostimulation and / or protein supplementation on obesity and cardiometabolic risk in older men with sarcopenic obesity: the randomized controlled FranSO trial. BMC Geriatr. 2018 Mar 9;18(1):70. doi: 10.1186/s12877-018-0759-6. |
| 28220197 | Derived | Kemmler W, Teschler M, Weissenfels A, Sieber C, Freiberger E, von Stengel S. Prevalence of sarcopenia and sarcopenic obesity in older German men using recognized definitions: high accordance but low overlap! Osteoporos Int. 2017 Jun;28(6):1881-1891. doi: 10.1007/s00198-017-3964-9. Epub 2017 Feb 20. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000602 | Amino Acids, Peptides, and Proteins |