Effect of Whole Body Electromyostimulation and/or Protein Supplementation on Sarcopenic Obesity in 70+

Study Overview
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Brief Summary
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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

Detailed Description
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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).

Official Title
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Effect of Whole-body Electromyostimulation (WB-EMS) and/or Protein Supplementation on Sarcopenic Obesity in Community Dwelling Males 70+ With Sarcopenic Obesity

Conditions
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Sarcopenic Obesity

Intervention / Treatment
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* Other: Whole body Electromyostimulation (exercise)
* Dietary Supplement: Protein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole-Body Electromyostimulation and Protein<br>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 | Other: Whole body Electromyostimulation (exercise)<br>* 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.<br>* Other names: Electrostimulation;Dietary Supplement: Protein<br>* up to 1.5-1.7 g/kg bodymass/d of protein (whey protein)<br>|
| Active Comparator: Protein supplementation<br>up to 1.5 - 1.7 g/kg body mass/d of protein supplements up to 800 IU/d Vitamin D-Supplementation | Dietary Supplement: Protein<br>* up to 1.5-1.7 g/kg bodymass/d of protein (whey protein)<br>|
| No Intervention: sedentary Control Group<br>No protein supplementation or WB-EMS-application, but up to 800 IU/d Vitamin D-Supplementation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcopenia, Obesity, Whole-Body Electromyostimulation, Protein Supplementation, community dwelling men