Clinical trial NCT02356016: Effects of Whole-body Electromyostimulation and Dietary Supplements on "Sarcopenic Obesity"
Official title: Effects of Whole-body Electromyostimulation and Dietary Supplements on "Sarcopenic Obesity" in Elderly Females Living in the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Sarcopenic Obesity
Keywords: Sarcopenic Obesity
community dwelling elderly women
electromyostimulation
exercise
dietary supplements
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: University of Erlangen-Nürnberg
name: Bavarian Research Foundation, Munich, Germany
name: miha bodytec, Gersthofen, Germany
name: Physiomed, Laipersdorf, Germany
name: Siemens AG
First posted: 2015-02-05
Enrollment: 75
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Appendicular skeletal muscle mass
timeFrame: baseline - 6 months follow-up
measure: Muscle density of the medial thigh
timeFrame: baseline - 6 months follow-up
measure: Intramuscular fat content
timeFrame: baseline - 6 months follow-up
Secondary outcomes:
measure: Muscle cross sectional area (CSA)
timeFrame: baseline - 6 months follow-up
measure: Isokinetic leg strength
timeFrame: baseline - 6 months follow-up
measure: Short Physical Performance Battery (SPPB)
timeFrame: baseline - 6 months follow-up
measure: Hand grip of the dominant hand
timeFrame: baseline - 6 months follow-up
measure: muscular power of the legs
timeFrame: baseline - 6 months follow-up
Other outcomes:
measure: Balance according to SPPB
timeFrame: baseline - 6 months follow-up
measure: Quality of life
timeFrame: baseline - 6 months follow-up
measure: Trial Making Tests A and B
timeFrame: baseline - 6 months follow-up
Locations:
Study officials:
affiliation: Institute of Biomedicine of Age, University of Erlangen-Nuremberg
name: Cornel Sieber, MD
role: STUDY_CHAIR
affiliation: Institute of Biomedicine of Age, University of Erlangen-Nuremberg
name: Cornelius Bollheimer, MD
role: STUDY_CHAIR
affiliation: Institute of Medical Physics, University of Erlangen-Nuremberg
name: Klaus Engelke, PhD
role: STUDY_DIRECTOR
affiliation: Institute of Medical Physics, University of Erlangen-Nuremberg
name: Wolfgang Kemmler, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Biomedicine of Age, University of Erlangen-Nuremberg
name: Ellen Freiberger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.