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

Phase 2

Completed

• Conditions: Sarcopenic Obesity
• Interventions: Other: control (dietary counseling); Behavioral: WB-EMS Intervention; Behavioral: WB-EMS-Intervention and dietary supplementation

• Registration Number: NCT02356016
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-05
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-20
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	control (dietary counseling)	Monthly dietary counseling for 6 months
Whole body Electromyostimulation (WB-EMS)	WB-EMS Intervention	18 min of WB-EMS/week (one session/week)
WB-EMS and Nutritional Supplements	WB-EMS-Intervention and dietary supplementation	18 min of WB-EMS/week (one session/week) and supplements with high protein (Leucin) contents

Primary Outcome Measures

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

Secondary Outcome Measures

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