Effect of Whole Body Electromyostimulation and/or Protein Supplementation on Sarcopenic Obesity in 70+
NCT ID: NCT02857660
Last Updated: 2017-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2016-08-31
2017-04-30
Brief Summary
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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
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Whole-Body Electromyostimulation and Protein
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
Whole body Electromyostimulation (exercise)
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.
Protein
up to 1.5-1.7 g/kg bodymass/d of protein (whey protein)
Protein supplementation
up to 1.5 - 1.7 g/kg body mass/d of protein supplements up to 800 IU/d Vitamin D-Supplementation
Protein
up to 1.5-1.7 g/kg bodymass/d of protein (whey protein)
sedentary Control Group
No protein supplementation or WB-EMS-application, but up to 800 IU/d Vitamin D-Supplementation
No interventions assigned to this group
Interventions
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Whole body Electromyostimulation (exercise)
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.
Protein
up to 1.5-1.7 g/kg bodymass/d of protein (whey protein)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Sarcopenia
* Obesity (body fat \>=25%)
Exclusion Criteria
* absence of more than 2 weeks during the study period
70 Years
MALE
Yes
Sponsors
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University of Erlangen-Nürnberg Institute of Medical Physics
UNKNOWN
University of Erlangen-Nürnberg Institute of Biomedicine of Aging
UNKNOWN
University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Principal Investigators
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Cornel Sieber, MD
Role: STUDY_CHAIR
Institute of Biomedicine of Aging, University of Erlangen-Nürnberg
Klaus Engelke, PhD
Role: STUDY_CHAIR
University of Erlangen-Nürnberg Medical School
Ellen Freiberger, PhD
Role: STUDY_CHAIR
Institute of Biomedicine of Aging, University of Erlangen-Nürnberg
Anja Weissenfels, MA
Role: PRINCIPAL_INVESTIGATOR
University of Erlangen-Nürnberg Medical School
Wolfgang Kemmler, PhD
Role: STUDY_DIRECTOR
University of Erlangen-Nürnberg Medical School
Locations
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Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg
Erlangen, Bavaria, Germany
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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FRANSO_2016_IMP
Identifier Type: -
Identifier Source: org_study_id
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