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Clinical Trials/NCT02356016
NCT02356016
Completed
Phase 2

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

University of Erlangen-Nürnberg Medical School0 sites75 target enrollmentAugust 2013

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Sarcopenic Obesity
Sponsor
University of Erlangen-Nürnberg Medical School
Enrollment
75
Primary Endpoint
Muscle density of the medial thigh
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University of Erlangen-Nürnberg Medical School
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Muscle density of the medial thigh

Time Frame: baseline - 6 months follow-up

changes of muscle density (thigh) from baseline to 6 month follow-up

Appendicular skeletal muscle mass

Time Frame: baseline - 6 months follow-up

changes of appendicular skeletal muscle mass from baseline to 6 month follow-up

Intramuscular fat content

Time Frame: baseline - 6 months follow-up

changes of Intramuscular fat content (thigh) from baseline to 6 month follow-up

Secondary Outcomes

  • 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)

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