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

Sarcopenic Obesity Clinical Trial

— FRANSO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02857660
• Other study ID #: FRANSO_2016_IMP
• Status: Completed
• Phase: Phase 3
• First received: July 28, 2016
• Last updated: May 1, 2017
• Start date: August 2016
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Sarcopenic Obesity

Intervention

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.

Dietary Supplement:
• Protein
up to 1.5-1.7 g/kg bodymass/d of protein (whey protein)

Locations

Country	Name	City	State
Germany	Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg	Erlangen	Bavaria

Sponsors (3)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	University of Erlangen-Nürnberg Institute of Biomedicine of Aging, University of Erlangen-Nürnberg Institute of Medical Physics

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change of Obesity	Assessment of body fat content and body mass index	Change from Baseline Obesity at 16 weeks
Secondary	Change of Metabolic Syndrome Z-Score	Metabolic Syndrome according to the International Diabetes Federation (IDF)	Change from Baseline Metabolic Syndrome Z-Score at 16 weeks
Secondary	Change of isokinetic leg strength	Dynamic strength of the leg extensors and flexors as determined by a isokinetic leg press	Change from Baseline isokinetic leg strength at 16 weeks
Secondary	Change of Quality of Life	Quality of life as determined by the SF-12 questionnaire	Change from Baseline Quality of life at 16 weeks
Secondary	Change of Physical Disability	Physical disability as assessed by Late Life Functional and Disability Index (LLFDI)	Change from Baseline Physical Disability at 16 weeks
Secondary	Change of Back Extensors Strength	Strength of the back extensors and flexors using the Doctor Wolff Backcheck device	Change from Baseline Back Extensors Strength at 16 weeks