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Completed

NCT Number: NCT02356016

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

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.

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Key information

Conditions

Sarcopenic Obesity Behavior Motor Activity

Age range

70 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WB-EMS Intervention

Behavioral

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

WB-EMS-Intervention and dietary supplementation

Behavioral

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

control (dietary counseling)

Other

Monthly dietary counseling only

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

  • Bavarian Research Foundation, Munich, Germany
  • Physiomed, Laipersdorf, Germany
  • Siemens AG
  • University of Erlangen-Nürnberg
  • miha bodytec, Gersthofen, Germany

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 5, 2015
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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