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

NCT02857660 | Completed Phase 3

• 1 other identifier: FRANSO_2016_IMP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Sarcopenic Obesity

Keywords

Sarcopenia; Obesity; Whole-Body Electromyostimulation; Protein Supplementation; community dwelling men

Outcome Measures

Primary Outcomes (2)

• Change of Sarcopenia Z-Score

  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

  Assessment of body fat content and body mass index

  Change from Baseline Obesity at 16 weeks

Secondary Outcomes (5)

• Change of Metabolic Syndrome Z-Score

  Change from Baseline Metabolic Syndrome Z-Score at 16 weeks

• Change of isokinetic leg strength

  Change from Baseline isokinetic leg strength at 16 weeks

• Change of Quality of Life

  Change from Baseline Quality of life at 16 weeks

• Change of Physical Disability

  Change from Baseline Physical Disability at 16 weeks

• Change of Back Extensors Strength

  Change from Baseline Back Extensors Strength at 16 weeks

Study Arms (3)

Whole-Body Electromyostimulation and Protein

EXPERIMENTAL

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); Dietary Supplement: Protein

Protein supplementation

ACTIVE COMPARATOR

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

sedentary Control Group

NO INTERVENTION

No protein supplementation or WB-EMS-application, but up to 800 IU/d Vitamin D-Supplementation

Interventions

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.

Also known as: Electrostimulation

Whole-Body Electromyostimulation and Protein

Protein DIETARY_SUPPLEMENT

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

Protein supplementation; Whole-Body Electromyostimulation and Protein

Eligibility Criteria

• Age: 70 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• community dwelling, independent living men
• Sarcopenia
• Obesity (body fat \>=25%)

You may not qualify if:

• diseases/medication that affect the study endpoints (e.g. Glucocorticoids \>5mg/d)
• absence of more than 2 weeks during the study period

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• University of Erlangen-Nürnberg Institute of Medical Physics: collaborator
• University of Erlangen-Nürnberg Institute of Biomedicine of Aging: collaborator

Study Sites (1)

Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg

Erlangen, Bavaria, 91052, Germany

Location

Related Publications (8)

• Kemmler W, Teschler M, Weissenfels A, Bebenek M, von Stengel S, Kohl M, Freiberger E, Goisser S, Jakob F, Sieber C, Engelke K. Whole-body electromyostimulation to fight sarcopenic obesity in community-dwelling older women at risk. Resultsof the randomized controlled FORMOsA-sarcopenic obesity study. Osteoporos Int. 2016 Nov;27(11):3261-3270. doi: 10.1007/s00198-016-3662-z. Epub 2016 Jun 12.

  PMID: 27289534 BACKGROUND

• Kemmler W, Teschler M, Goisser S, Bebenek M, von Stengel S, Bollheimer LC, Sieber CC, Freiberger E. Prevalence of sarcopenia in Germany and the corresponding effect of osteoarthritis in females 70 years and older living in the community: results of the FORMoSA study. Clin Interv Aging. 2015 Oct 3;10:1565-73. doi: 10.2147/CIA.S89585. eCollection 2015.

  PMID: 26491272 BACKGROUND

• Kemmler W, von Stengel S, Engelke K, Sieber C, Freiberger E. Prevalence of sarcopenic obesity in Germany using established definitions: Baseline data of the FORMOsA study. Osteoporos Int. 2016 Jan;27(1):275-81. doi: 10.1007/s00198-015-3303-y. Epub 2015 Aug 29.

  PMID: 26318759 BACKGROUND

• Goisser S, Kemmler W, Porzel S, Volkert D, Sieber CC, Bollheimer LC, Freiberger E. Sarcopenic obesity and complex interventions with nutrition and exercise in community-dwelling older persons--a narrative review. Clin Interv Aging. 2015 Aug 6;10:1267-82. doi: 10.2147/CIA.S82454. eCollection 2015.

  PMID: 26346071 BACKGROUND

• Chaudry O, Friedberger A, Grimm A, Uder M, Nagel AM, Kemmler W, Engelke K. Segmentation of the fascia lata and reproducible quantification of intermuscular adipose tissue (IMAT) of the thigh. MAGMA. 2021 Jun;34(3):367-376. doi: 10.1007/s10334-020-00878-w. Epub 2020 Aug 6.

  PMID: 32761398 DERIVED

• Kemmler W, Grimm A, Bebenek M, Kohl M, von Stengel S. Effects of Combined Whole-Body Electromyostimulation and Protein Supplementation on Local and Overall Muscle/Fat Distribution in Older Men with Sarcopenic Obesity: The Randomized Controlled Franconia Sarcopenic Obesity (FranSO) Study. Calcif Tissue Int. 2018 Sep;103(3):266-277. doi: 10.1007/s00223-018-0424-2. Epub 2018 Apr 19.

  PMID: 29675640 DERIVED

• Kemmler W, Kohl M, Freiberger E, Sieber C, von Stengel S. Effect of whole-body electromyostimulation and / or protein supplementation on obesity and cardiometabolic risk in older men with sarcopenic obesity: the randomized controlled FranSO trial. BMC Geriatr. 2018 Mar 9;18(1):70. doi: 10.1186/s12877-018-0759-6.

  PMID: 29523089 DERIVED

• Kemmler W, Teschler M, Weissenfels A, Sieber C, Freiberger E, von Stengel S. Prevalence of sarcopenia and sarcopenic obesity in older German men using recognized definitions: high accordance but low overlap! Osteoporos Int. 2017 Jun;28(6):1881-1891. doi: 10.1007/s00198-017-3964-9. Epub 2017 Feb 20.

  PMID: 28220197 DERIVED

MeSH Terms

Conditions

Sarcopenia; Obesity

Interventions

Exercise; Transcutaneous Electric Nerve Stimulation; Proteins

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Amino Acids, Peptides, and Proteins

Study Officials

• Cornel Sieber, MD

  Institute of Biomedicine of Aging, University of Erlangen-Nürnberg

  STUDY CHAIR

• Klaus Engelke, PhD

  University of Erlangen-Nürnberg Medical School

  STUDY CHAIR

• Ellen Freiberger, PhD

  Institute of Biomedicine of Aging, University of Erlangen-Nürnberg

  STUDY CHAIR

• Anja Weissenfels, MA

  University of Erlangen-Nürnberg Medical School

  PRINCIPAL INVESTIGATOR

• Wolfgang Kemmler, PhD

  University of Erlangen-Nürnberg Medical School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 5, 2016
• Study Start: August 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 2, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)