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

Study Overview
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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.

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

Conditions
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Sarcopenic Obesity

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


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Whole body Electromyostimulation (WB-EMS)<br>18 min of WB-EMS/week (one session/week) | Behavioral: WB-EMS Intervention<br>* Supervised WB-EMS Intervention 18 min/session (one session/week) and monthly dietary counseling for 6 months<br>|
| Active Comparator: WB-EMS and Nutritional Supplements<br>18 min of WB-EMS/week (one session/week) and supplements with high protein (Leucin) contents | Behavioral: WB-EMS-Intervention and dietary supplementation<br>* Supervised WB-EMS Intervention and dietary supplementation and monthly dietary counseling for 6 months<br>|
| Sham Comparator: Control<br>Monthly dietary counseling for 6 months | Other: control (dietary counseling)<br>* Monthly dietary counseling only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle cross sectional area (CSA) | changes of muscle CSA (thigh) from baseline to 6 month follow-up | baseline - 6 months follow-up | 
| Isokinetic leg strength | changes of isokinetic leg strength from baseline to 6 month follow-up | baseline - 6 months follow-up | 
| Short Physical Performance Battery (SPPB) | SPPB according to Guralnik et al. (J Gerontol Med Sci1994; 49(2):M85-M94) | baseline - 6 months follow-up | 
| Hand grip of the dominant hand | Maximum isometric strength of the dominant hand (dynamometer) | baseline - 6 months follow-up | 
| muscular power of the legs | Muscular power of the legs (jumping test), by Leonardo (Novotec, Germany) | baseline - 6 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcopenic Obesity, community dwelling elderly women, electromyostimulation, exercise, dietary supplements