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

May 1, 2017 updated by: University of Erlangen-Nürnberg Medical School

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Erlangen, Bavaria, Germany, 91052
        • Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

68 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole-Body Electromyostimulation and Protein
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)
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
Dietary supplement: Protein
up to 1.5-1.7 g/kg bodymass/d of protein (whey protein)
Active Comparator: Protein supplementation
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
up to 1.5-1.7 g/kg bodymass/d of protein (whey protein)
No Intervention: sedentary Control Group
No protein supplementation or WB-EMS-application, but up to 800 IU/d Vitamin D-Supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from Baseline Sarcopenia Z-Score at 16 weeks
Change of Obesity
Time Frame: Change from Baseline Obesity at 16 weeks
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
Time Frame: Change from Baseline Metabolic Syndrome Z-Score at 16 weeks
Metabolic Syndrome according to the International Diabetes Federation (IDF)
Change from Baseline Metabolic Syndrome Z-Score at 16 weeks
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
Change from Baseline isokinetic leg strength at 16 weeks
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
Change from Baseline Quality of life at 16 weeks
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)
Change from Baseline Physical Disability at 16 weeks
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
Change from Baseline Back Extensors Strength at 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

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

Investigators

  • Study Director: Wolfgang Kemmler, PhD, University of Erlangen-Nürnberg Medical School
  • Study Chair: Klaus Engelke, PhD, University of Erlangen-Nürnberg Medical School
  • Study Chair: Cornel Sieber, MD, Institute of Biomedicine of Aging, University of Erlangen-Nürnberg
  • Study Chair: Ellen Freiberger, PhD, Institute of Biomedicine of Aging, University of Erlangen-Nürnberg
  • Principal Investigator: Anja Weissenfels, MA, University of Erlangen-Nürnberg Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRANSO_2016_IMP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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