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Completed

NCT Number: NCT02857660

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

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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Key information

Age range

70 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg

Erlangen, Bavaria, 91052, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole body Electromyostimulation (exercise)

Other

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

Protein

Dietary Supplement

up to 1.5-1.7 g/kg bodymass/d of protein (whey protein)

Primary outcomes

  1. Change of Sarcopenia Z-Score

    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

  2. Change of Obesity

    Time frame: Change from Baseline Obesity at 16 weeks

    Assessment of body fat content and body mass index

Secondary outcomes

  1. Change of Metabolic Syndrome Z-Score

    Time frame: Change from Baseline Metabolic Syndrome Z-Score at 16 weeks

    Metabolic Syndrome according to the International Diabetes Federation (IDF)

  2. Change of isokinetic leg strength

    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

  3. Change of Quality of Life

    Time frame: Change from Baseline Quality of life at 16 weeks

    Quality of life as determined by the SF-12 questionnaire

  4. Change of Physical Disability

    Time frame: Change from Baseline Physical Disability at 16 weeks

    Physical disability as assessed by Late Life Functional and Disability Index (LLFDI)

  5. Change of Back Extensors Strength

    Time frame: Change from Baseline Back Extensors Strength at 16 weeks

    Strength of the back extensors and flexors using the Doctor Wolff Backcheck device

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

  • University of Erlangen-Nürnberg Institute of Biomedicine of Aging
  • University of Erlangen-Nürnberg Institute of Medical Physics

Registry information

Official study title

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

Acronym: FRANSO

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 5, 2016
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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