Sarcopenic Obesity
Conditions
Keywords
Sarcopenia, Obesity, Whole-Body Electromyostimulation, Protein Supplementation, community dwelling men
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).
Interventions
OTHERWhole 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.
DIETARY_SUPPLEMENTProtein
up to 1.5-1.7 g/kg bodymass/d of protein (whey protein)
Sponsors
University of Erlangen-Nürnberg Institute of Medical Physics
University of Erlangen-Nürnberg Institute of Biomedicine of Aging
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* community dwelling, independent living men * Sarcopenia * Obesity (body fat \>=25%)
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Sarcopenia Z-Score | 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 |
| Change of Obesity | Change from Baseline Obesity at 16 weeks | Assessment of body fat content and body mass index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Quality of Life | Change from Baseline Quality of life at 16 weeks | Quality of life as determined by the SF-12 questionnaire |
| Change of Metabolic Syndrome Z-Score | Change from Baseline Metabolic Syndrome Z-Score at 16 weeks | Metabolic Syndrome according to the International Diabetes Federation (IDF) |
| Change of Back Extensors Strength | Change from Baseline Back Extensors Strength at 16 weeks | Strength of the back extensors and flexors using the Doctor Wolff Backcheck device |
| Change of Physical Disability | Change from Baseline Physical Disability at 16 weeks | Physical disability as assessed by Late Life Functional and Disability Index (LLFDI) |
| Change of isokinetic leg strength | Change from Baseline isokinetic leg strength at 16 weeks | Dynamic strength of the leg extensors and flexors as determined by a isokinetic leg press |
Countries
Germany
Outcome results
None listed