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

NCT ID: NCT02356016

Last Updated: 2016-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-05-31

Brief Summary

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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

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Conditions

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Sarcopenic Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Whole body Electromyostimulation (WB-EMS)

18 min of WB-EMS/week (one session/week)

Group Type ACTIVE_COMPARATOR

WB-EMS Intervention

Intervention Type BEHAVIORAL

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

WB-EMS and Nutritional Supplements

18 min of WB-EMS/week (one session/week) and supplements with high protein (Leucin) contents

Group Type ACTIVE_COMPARATOR

WB-EMS-Intervention and dietary supplementation

Intervention Type BEHAVIORAL

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

Control

Monthly dietary counseling for 6 months

Group Type SHAM_COMPARATOR

control (dietary counseling)

Intervention Type OTHER

Monthly dietary counseling only

Interventions

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WB-EMS Intervention

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

Intervention Type BEHAVIORAL

WB-EMS-Intervention and dietary supplementation

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

Intervention Type BEHAVIORAL

control (dietary counseling)

Monthly dietary counseling only

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Erlangen-Nürnberg

OTHER

Sponsor Role collaborator

Bavarian Research Foundation, Munich, Germany

UNKNOWN

Sponsor Role collaborator

miha bodytec, Gersthofen, Germany

UNKNOWN

Sponsor Role collaborator

Physiomed, Laipersdorf, Germany

UNKNOWN

Sponsor Role collaborator

Siemens AG

INDUSTRY

Sponsor Role collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cornel Sieber, MD

Role: STUDY_CHAIR

Institute of Biomedicine of Age, University of Erlangen-Nuremberg

Cornelius Bollheimer, MD

Role: STUDY_CHAIR

Institute of Biomedicine of Age, University of Erlangen-Nuremberg

Klaus Engelke, PhD

Role: STUDY_DIRECTOR

Institute of Medical Physics, University of Erlangen-Nuremberg

Wolfgang Kemmler, PHD

Role: PRINCIPAL_INVESTIGATOR

Institute of Medical Physics, University of Erlangen-Nuremberg

Ellen Freiberger, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Biomedicine of Age, University of Erlangen-Nuremberg

References

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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.

Reference Type BACKGROUND
PMID: 23949160 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24130433 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27289534 (View on PubMed)

Other Identifiers

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FORMOsA P2 TP3

Identifier Type: -

Identifier Source: org_study_id

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