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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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02356016
Enrollment
75
Registered
2015-02-05
Start date
2013-08-31
Completion date
2016-05-31
Last updated
2016-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenic Obesity

Keywords

Sarcopenic Obesity, community dwelling elderly women, electromyostimulation, exercise, dietary supplements

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.

Interventions

BEHAVIORALWB-EMS-Intervention and dietary supplementation

Supervised WB-EMS Intervention and dietary supplementation and monthly dietary counseling for 6 months

OTHERcontrol (dietary counseling)

Monthly dietary counseling only

BEHAVIORALWB-EMS Intervention

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

Sponsors

University of Erlangen-Nürnberg
CollaboratorOTHER
Bavarian Research Foundation, Munich, Germany
CollaboratorUNKNOWN
miha bodytec, Gersthofen, Germany
CollaboratorUNKNOWN
Physiomed, Laipersdorf, Germany
CollaboratorUNKNOWN
Siemens AG
CollaboratorINDUSTRY
University of Erlangen-Nürnberg Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
70 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Appendicular skeletal muscle massbaseline - 6 months follow-upchanges of appendicular skeletal muscle mass from baseline to 6 month follow-up
Intramuscular fat contentbaseline - 6 months follow-upchanges of Intramuscular fat content (thigh) from baseline to 6 month follow-up
Muscle density of the medial thighbaseline - 6 months follow-upchanges of muscle density (thigh) from baseline to 6 month follow-up

Secondary

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

Other

MeasureTime frameDescription
Balance according to SPPBbaseline - 6 months follow-upBalance according to SPPB (see above), Soehnle balance platform device (Soehnle Germany)
Trial Making Tests A and Bbaseline - 6 months follow-upTMT-L: Trail Making Test - Langensteinbacher version.
Quality of lifebaseline - 6 months follow-upQuality of Life: EUROQuOI questionnaire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026