Effects of Whole-body Electromyostimulation and Dietary Supplements on "Sarcopenic Obesity"
1 other identifier
interventional
75
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 21, 2015
CompletedFirst Posted
Study publicly available on registry
February 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedMay 23, 2016
May 1, 2016
2.8 years
January 21, 2015
May 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (5)
Muscle cross sectional area (CSA)
baseline - 6 months follow-up
Isokinetic leg strength
baseline - 6 months follow-up
Short Physical Performance Battery (SPPB)
baseline - 6 months follow-up
Hand grip of the dominant hand
baseline - 6 months follow-up
muscular power of the legs
baseline - 6 months follow-up
Other Outcomes (3)
Balance according to SPPB
baseline - 6 months follow-up
Quality of life
baseline - 6 months follow-up
Trial Making Tests A and B
baseline - 6 months follow-up
Study Arms (3)
Whole body Electromyostimulation (WB-EMS)
ACTIVE COMPARATOR18 min of WB-EMS/week (one session/week)
WB-EMS and Nutritional Supplements
ACTIVE COMPARATOR18 min of WB-EMS/week (one session/week) and supplements with high protein (Leucin) contents
Control
SHAM COMPARATORMonthly dietary counseling for 6 months
Interventions
Supervised WB-EMS Intervention 18 min/session (one session/week) and monthly dietary counseling for 6 months
Supervised WB-EMS Intervention and dietary supplementation and monthly dietary counseling for 6 months
Eligibility Criteria
You may qualify if:
- community dwelling
- Sarcopenic Obesity
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Erlangen-Nürnberg Medical Schoollead
- University of Erlangen-Nürnbergcollaborator
- Bavarian Research Foundation, Munich, Germanycollaborator
- miha bodytec, Gersthofen, Germanycollaborator
- Physiomed, Laipersdorf, Germanycollaborator
- Siemens AGcollaborator
Related Publications (3)
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.
PMID: 23949160BACKGROUNDKemmler 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.
PMID: 24130433BACKGROUNDKemmler 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.
PMID: 27289534DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2015
First Posted
February 5, 2015
Study Start
August 1, 2013
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
May 23, 2016
Record last verified: 2016-05