Effects of Whole-body Electromyostimulation and Dietary Supplements on "Sarcopenic Obesity"

Effects of Whole-body Electromyostimulation and Dietary Supplements on "Sarcopenic Obesity" in Elderly Females Living in the Community

The aim of the study is to determine the effect of whole body electromyostimulation (WB-EMS) and/or nutritional on body composition and functional tasks in elderly females with sarcopenic obesity. Seventy-five, non-sportive, independently living women 70 years and older with Sarcopenic Obesity were randomly assigned to either a WB-EMS group ( n=25), a WB-EMS/nutritional supplements (n=25) or a semi-active control group (an=25). The WB-EMS protocol applied one session of 18 min/week of WB-EMS (bipolar, 85 Hz). Nutritional strategy based on a high protein supplement.

Study Overview

• Status: Completed
• Conditions: Sarcopenic Obesity
• Intervention / Treatment: Behavioral: WB-EMS Intervention; Behavioral: WB-EMS-Intervention and dietary supplementation; Other: control (dietary counseling)

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• community dwelling
• Sarcopenic Obesity

Exclusion Criteria:

• exercising more than 60 min/week
• more than 4 weeks absent during the interventional period,
• injuries (i.e. hip TotalEndoProsthesis (TEP), abdomen/groin hernia) or diseases (i.e. epilepsy, cardiac arrhythmia) that prevent WB-EMS intervention
• medication and/or diseases affecting our primary endpoints.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Whole body Electromyostimulation (WB-EMS); 18 min of WB-EMS/week (one session/week)	Behavioral: WB-EMS Intervention; Supervised WB-EMS Intervention 18 min/session (one session/week) and monthly dietary counseling for 6 months
Active Comparator: WB-EMS and Nutritional Supplements; 18 min of WB-EMS/week (one session/week) and supplements with high protein (Leucin) contents	Behavioral: WB-EMS-Intervention and dietary supplementation; Supervised WB-EMS Intervention and dietary supplementation and monthly dietary counseling for 6 months
Sham Comparator: Control; Monthly dietary counseling for 6 months	Other: control (dietary counseling); Monthly dietary counseling only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appendicular skeletal muscle mass	changes of appendicular skeletal muscle mass from baseline to 6 month follow-up	baseline - 6 months follow-up
Muscle density of the medial thigh	changes of muscle density (thigh) from baseline to 6 month follow-up	baseline - 6 months follow-up
Intramuscular fat content	changes of Intramuscular fat content (thigh) from baseline to 6 month follow-up	baseline - 6 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle cross sectional area (CSA)	changes of muscle CSA (thigh) from baseline to 6 month follow-up	baseline - 6 months follow-up
Isokinetic leg strength	changes of isokinetic leg strength from baseline to 6 month follow-up	baseline - 6 months follow-up
Short Physical Performance Battery (SPPB)	SPPB according to Guralnik et al. (J Gerontol Med Sci1994; 49(2):M85-M94)	baseline - 6 months follow-up
Hand grip of the dominant hand	Maximum isometric strength of the dominant hand (dynamometer)	baseline - 6 months follow-up
muscular power of the legs	Muscular power of the legs (jumping test), by Leonardo (Novotec, Germany)	baseline - 6 months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance according to SPPB	Balance according to SPPB (see above), Soehnle balance platform device (Soehnle Germany)	baseline - 6 months follow-up
Quality of life	Quality of Life: EUROQuOI questionnaire	baseline - 6 months follow-up
Trial Making Tests A and B	TMT-L: Trail Making Test - Langensteinbacher version.	baseline - 6 months follow-up

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Collaborators: University of Erlangen-Nürnberg; Siemens AG; Bavarian Research Foundation, Munich, Germany; miha bodytec, Gersthofen, Germany; Physiomed, Laipersdorf, Germany
• Investigators: Study Chair: Cornel Sieber, MD, Institute of Biomedicine of Age, University of Erlangen-Nuremberg; Study Chair: Cornelius Bollheimer, MD, Institute of Biomedicine of Age, University of Erlangen-Nuremberg; Study Director: Klaus Engelke, PhD, Institute of Medical Physics, University of Erlangen-Nuremberg; Principal Investigator: Wolfgang Kemmler, PHD, Institute of Medical Physics, University of Erlangen-Nuremberg; Principal Investigator: Ellen Freiberger, PhD, Institute of Biomedicine of Age, University of Erlangen-Nuremberg

Publications and helpful links

General Publications

• Kemmler W, von Stengel S. Whole-body electromyostimulation as a means to impact muscle mass and abdominal body fat in lean, sedentary, older female adults: subanalysis of the TEST-III trial. Clin Interv Aging. 2013;8:1353-64. doi: 10.2147/CIA.S52337. Epub 2013 Oct 7.
• Kemmler W, Bebenek M, Engelke K, von Stengel S. Impact of whole-body electromyostimulation on body composition in elderly women at risk for sarcopenia: the Training and ElectroStimulation Trial (TEST-III). Age (Dordr). 2014 Feb;36(1):395-406. doi: 10.1007/s11357-013-9575-2. Epub 2013 Aug 16.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: January 21, 2015
• First Submitted That Met QC Criteria: February 4, 2015
• First Posted (Estimate): February 5, 2015

Study Record Updates

• Last Update Posted (Estimate): May 23, 2016
• Last Update Submitted That Met QC Criteria: May 20, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: exercise; dietary supplements; Sarcopenic Obesity; community dwelling elderly women; electromyostimulation
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: FORMOsA P2 TP3