Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg
Erlangen, Bavaria, 91052, Germany
NCT Number: NCT02857660
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
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Notify Me70 year and older
Male
Interventional
Phase 3
Erlangen, Bavaria, 91052, Germany
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Electrostimulation
up to 1.5-1.7 g/kg bodymass/d of protein (whey protein)
Time frame: Change from Baseline Sarcopenia Z-Score at 16 weeks
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
Time frame: Change from Baseline Obesity at 16 weeks
Assessment of body fat content and body mass index
Time frame: Change from Baseline Metabolic Syndrome Z-Score at 16 weeks
Metabolic Syndrome according to the International Diabetes Federation (IDF)
Time frame: Change from Baseline isokinetic leg strength at 16 weeks
Dynamic strength of the leg extensors and flexors as determined by a isokinetic leg press
Time frame: Change from Baseline Quality of life at 16 weeks
Quality of life as determined by the SF-12 questionnaire
Time frame: Change from Baseline Physical Disability at 16 weeks
Physical disability as assessed by Late Life Functional and Disability Index (LLFDI)
Time frame: Change from Baseline Back Extensors Strength at 16 weeks
Strength of the back extensors and flexors using the Doctor Wolff Backcheck device
University of Erlangen-Nürnberg Medical School
Other
Effect of Whole-body Electromyostimulation (WB-EMS) and/or Protein Supplementation on Sarcopenic Obesity in Community Dwelling Males 70+ With Sarcopenic Obesity
Acronym: FRANSO
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