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

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ClinicalTrials.gov Identifier: NCT02356016
Recruitment Status : Completed
First Posted : February 5, 2015
Last Update Posted : May 23, 2016
Sponsor:
Collaborators:
University of Erlangen-Nürnberg
Bavarian Research Foundation, Munich, Germany
miha bodytec, Gersthofen, Germany
Physiomed, Laipersdorf, Germany
Siemens AG
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

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.

Condition or disease Intervention/treatment Phase
Sarcopenic Obesity Behavioral: WB-EMS Intervention Behavioral: WB-EMS-Intervention and dietary supplementation Other: control (dietary counseling) Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Whole-body Electromyostimulation and Dietary Supplements on "Sarcopenic Obesity" in Elderly Females Living in the Community
Study Start Date : August 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Whole body Electromyostimulation (WB-EMS)
18 min of WB-EMS/week (one session/week)
Behavioral: WB-EMS Intervention
Supervised WB-EMS Intervention 18 min/session (one session/week) and monthly dietary counseling for 6 months

Active Comparator: WB-EMS and Nutritional Supplements
18 min of WB-EMS/week (one session/week) and supplements with high protein (Leucin) contents
Behavioral: WB-EMS-Intervention and dietary supplementation
Supervised WB-EMS Intervention and dietary supplementation and monthly dietary counseling for 6 months

Sham Comparator: Control
Monthly dietary counseling for 6 months
Other: control (dietary counseling)
Monthly dietary counseling only




Primary Outcome Measures :
  1. Appendicular skeletal muscle mass [ Time Frame: baseline - 6 months follow-up ]
    changes of appendicular skeletal muscle mass from baseline to 6 month follow-up

  2. 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

  3. Intramuscular fat content [ Time Frame: baseline - 6 months follow-up ]
    changes of Intramuscular fat content (thigh) from baseline to 6 month follow-up


Secondary Outcome Measures :
  1. Muscle cross sectional area (CSA) [ Time Frame: baseline - 6 months follow-up ]
    changes of muscle CSA (thigh) from baseline to 6 month follow-up

  2. Isokinetic leg strength [ Time Frame: baseline - 6 months follow-up ]
    changes of isokinetic leg strength from baseline to 6 month follow-up

  3. Short Physical Performance Battery (SPPB) [ Time Frame: baseline - 6 months follow-up ]
    SPPB according to Guralnik et al. (J Gerontol Med Sci1994; 49(2):M85-M94)

  4. Hand grip of the dominant hand [ Time Frame: baseline - 6 months follow-up ]
    Maximum isometric strength of the dominant hand (dynamometer)

  5. muscular power of the legs [ Time Frame: baseline - 6 months follow-up ]
    Muscular power of the legs (jumping test), by Leonardo (Novotec, Germany)


Other Outcome Measures:
  1. Balance according to SPPB [ Time Frame: baseline - 6 months follow-up ]
    Balance according to SPPB (see above), Soehnle balance platform device (Soehnle Germany)

  2. Quality of life [ Time Frame: baseline - 6 months follow-up ]
    Quality of Life: EUROQuOI questionnaire

  3. Trial Making Tests A and B [ Time Frame: baseline - 6 months follow-up ]
    TMT-L: Trail Making Test - Langensteinbacher version.



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356016


Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg
Bavarian Research Foundation, Munich, Germany
miha bodytec, Gersthofen, Germany
Physiomed, Laipersdorf, Germany
Siemens AG
Investigators
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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT02356016     History of Changes
Other Study ID Numbers: FORMOsA P2 TP3
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: May 2016

Keywords provided by University of Erlangen-Nürnberg Medical School:
Sarcopenic Obesity
community dwelling elderly women
electromyostimulation
exercise
dietary supplements

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms