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

May 20, 2016 updated by: University of Erlangen-Nürnberg Medical School

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Appendicular skeletal muscle mass
Time Frame: baseline - 6 months follow-up
changes of appendicular skeletal muscle mass from baseline to 6 month follow-up
baseline - 6 months follow-up
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
baseline - 6 months 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
baseline - 6 months follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle cross sectional area (CSA)
Time Frame: baseline - 6 months follow-up
changes of muscle CSA (thigh) from baseline to 6 month follow-up
baseline - 6 months follow-up
Isokinetic leg strength
Time Frame: baseline - 6 months follow-up
changes of isokinetic leg strength from baseline to 6 month follow-up
baseline - 6 months follow-up
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)
baseline - 6 months follow-up
Hand grip of the dominant hand
Time Frame: baseline - 6 months follow-up
Maximum isometric strength of the dominant hand (dynamometer)
baseline - 6 months follow-up
muscular power of the legs
Time Frame: baseline - 6 months follow-up
Muscular power of the legs (jumping test), by Leonardo (Novotec, Germany)
baseline - 6 months follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Balance according to SPPB
Time Frame: baseline - 6 months follow-up
Balance according to SPPB (see above), Soehnle balance platform device (Soehnle Germany)
baseline - 6 months follow-up
Quality of life
Time Frame: baseline - 6 months follow-up
Quality of Life: EUROQuOI questionnaire
baseline - 6 months follow-up
Trial Making Tests A and B
Time Frame: baseline - 6 months follow-up
TMT-L: Trail Making Test - Langensteinbacher version.
baseline - 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Erlangen-Nürnberg Medical School

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Erlangen-Nürnberg
Siemens AG
Bavarian Research Foundation, Munich, Germany
miha bodytec, Gersthofen, Germany
Physiomed, Laipersdorf, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FORMOsA P2 TP3

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