Clinical trial NCT02857660: Effect of Whole Body Electromyostimulation and/or Protein Supplementation on Sarcopenic Obesity in 70+
Official title: Effect of Whole-body Electromyostimulation (WB-EMS) and/or Protein Supplementation on Sarcopenic Obesity in Community Dwelling Males 70+ With Sarcopenic Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sarcopenic Obesity
Keywords: Sarcopenia
Obesity
Whole-Body Electromyostimulation
Protein Supplementation
community dwelling men
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: University of Erlangen-Nürnberg Institute of Medical Physics
name: University of Erlangen-Nürnberg Institute of Biomedicine of Aging
First posted: 2016-08-05
Enrollment: 100
Sex: MALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* community dwelling, independent living men
* Sarcopenia
* Obesity (body fat \>=25%)

Exclusion Criteria:

* exclusion criteria for WB-EMS-application (e.g. cardiac pacemaker)
* diseases/medication that affect the study endpoints (e.g. Glucocorticoids \>5mg/d)
* absence of more than 2 weeks during the study period

Primary outcomes:
measure: Change of Sarcopenia Z-Score
timeFrame: Change from Baseline Sarcopenia Z-Score at 16 weeks
measure: Change of Obesity
timeFrame: Change from Baseline Obesity at 16 weeks
Secondary outcomes:
measure: Change of Metabolic Syndrome Z-Score
timeFrame: Change from Baseline Metabolic Syndrome Z-Score at 16 weeks
measure: Change of isokinetic leg strength
timeFrame: Change from Baseline isokinetic leg strength at 16 weeks
measure: Change of Quality of Life
timeFrame: Change from Baseline Quality of life at 16 weeks
measure: Change of Physical Disability
timeFrame: Change from Baseline Physical Disability at 16 weeks
measure: Change of Back Extensors Strength
timeFrame: Change from Baseline Back Extensors Strength at 16 weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg
state: Bavaria
Study officials:
affiliation: Institute of Biomedicine of Aging, University of Erlangen-Nürnberg
name: Cornel Sieber, MD
role: STUDY_CHAIR
affiliation: University of Erlangen-Nürnberg Medical School
name: Klaus Engelke, PhD
role: STUDY_CHAIR
affiliation: Institute of Biomedicine of Aging, University of Erlangen-Nürnberg
name: Ellen Freiberger, PhD
role: STUDY_CHAIR
affiliation: University of Erlangen-Nürnberg Medical School
name: Anja Weissenfels, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Erlangen-Nürnberg Medical School
name: Wolfgang Kemmler, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.