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

U

University of Erlangen-Nürnberg Medical School

Status and phase

Completed
Phase 3
Phase 2

Conditions

Sarcopenic Obesity

Treatments

Behavioral: WB-EMS Intervention
Behavioral: WB-EMS-Intervention and dietary supplementation
Other: control (dietary counseling)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02356016
FORMOsA P2 TP3

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

Female

Ages

70+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

75 participants in 3 patient groups

Whole body Electromyostimulation (WB-EMS)
Active Comparator group
Description:
18 min of WB-EMS/week (one session/week)
Treatment:
Behavioral: WB-EMS Intervention
WB-EMS and Nutritional Supplements
Active Comparator group
Description:
18 min of WB-EMS/week (one session/week) and supplements with high protein (Leucin) contents
Treatment:
Behavioral: WB-EMS-Intervention and dietary supplementation
Control
Sham Comparator group
Description:
Monthly dietary counseling for 6 months
Treatment:
Other: control (dietary counseling)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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