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

Sarcopenic Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356016
• Other study ID #: FORMOsA P2 TP3
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 21, 2015
• Last updated: May 20, 2016
• Start date: August 2013
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 70 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Sarcopenic Obesity

Intervention

Behavioral:
• WB-EMS Intervention
Supervised WB-EMS Intervention 18 min/session (one session/week) and monthly dietary counseling for 6 months
• WB-EMS-Intervention and dietary supplementation
Supervised WB-EMS Intervention and dietary supplementation and monthly dietary counseling for 6 months

Other:
• control (dietary counseling)
Monthly dietary counseling only

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Bavarian Research Foundation, Munich, Germany, miha bodytec, Gersthofen, Germany, Physiomed, Laipersdorf, Germany, Siemens AG, University of Erlangen-Nürnberg

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Balance according to SPPB	Balance according to SPPB (see above), Soehnle balance platform device (Soehnle Germany)	baseline - 6 months follow-up	No
Other	Quality of life	Quality of Life: EUROQuOI questionnaire	baseline - 6 months follow-up	No
Other	Trial Making Tests A and B	TMT-L: Trail Making Test - Langensteinbacher version.	baseline - 6 months follow-up	No
Primary	Appendicular skeletal muscle mass	changes of appendicular skeletal muscle mass from baseline to 6 month follow-up	baseline - 6 months follow-up	No
Primary	Muscle density of the medial thigh	changes of muscle density (thigh) from baseline to 6 month follow-up	baseline - 6 months follow-up	No
Primary	Intramuscular fat content	changes of Intramuscular fat content (thigh) from baseline to 6 month follow-up	baseline - 6 months follow-up	No
Secondary	Muscle cross sectional area (CSA)	changes of muscle CSA (thigh) from baseline to 6 month follow-up	baseline - 6 months follow-up	No
Secondary	Isokinetic leg strength	changes of isokinetic leg strength from baseline to 6 month follow-up	baseline - 6 months follow-up	No
Secondary	Short Physical Performance Battery (SPPB)	SPPB according to Guralnik et al. (J Gerontol Med Sci1994; 49(2):M85-M94)	baseline - 6 months follow-up	No
Secondary	Hand grip of the dominant hand	Maximum isometric strength of the dominant hand (dynamometer)	baseline - 6 months follow-up	No
Secondary	muscular power of the legs	Muscular power of the legs (jumping test), by Leonardo (Novotec, Germany)	baseline - 6 months follow-up	No