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

U

University of Erlangen-Nürnberg Medical School

Status and phase

Completed
Phase 3

Conditions

Sarcopenic Obesity

Treatments

Dietary Supplement: Protein
Other: Whole body Electromyostimulation (exercise)

Study type

Interventional

Funder types

Other

Identifiers

NCT02857660
FRANSO_2016_IMP

Details and patient eligibility

About

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

Full 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).

Enrollment

100 patients

Sex

Male

Ages

70+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 3 patient groups

Whole-Body Electromyostimulation and Protein
Experimental group
Description:
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
Treatment:
Other: Whole body Electromyostimulation (exercise)
Dietary Supplement: Protein
Protein supplementation
Active Comparator group
Description:
up to 1.5 - 1.7 g/kg body mass/d of protein supplements up to 800 IU/d Vitamin D-Supplementation
Treatment:
Dietary Supplement: Protein
sedentary Control Group
No Intervention group
Description:
No protein supplementation or WB-EMS-application, but up to 800 IU/d Vitamin D-Supplementation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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