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

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