Effect of Electromyostimulation on Bone

December 1, 2015 updated by: Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School

Effects of Whole-Body Electromyostimulation on Osteoporosis and Sarcopenia in Independently Living, Frail Elderly Females

Although there is some evidence that whole body electromyostimulation(WB-EMS) affect bone via its acute and longitudinal effects on muscle mass and strength, the corresponding impact on bone density and falls in older adults has not been assessed yet. The investigators hypothesize that WB-EMS significantly affects bone parameters as assessed by DXA, and significantly reduce fall rate and ratio in a cohort of frail elderly women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91052
        • Institute of Medical Physics, University of Erlangen-Nurnberg

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

Ages Eligible for Study

70 years to 99 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female gender
  • 70 years and older
  • osteopenia according to WHO
  • BMI < 24 kg/m2
  • living independently in the area of Erlangen-Nurnberg

Exclusion Criteria:

  • medication or diseases affecting bone metabolism (including HRT)
  • > 1 hour/week of exercise
  • epilepsy, grave neurologic disturbances,
  • cardiac pacemaker, grave circulatory disorders,
  • abdomen/groin hernia,
  • tuberculosis,
  • cancer,
  • inflammable diseases,
  • bleeding tendencies,

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: whole-body electromyostimulation
20 min of whole-body electromyostimulation with sequences of 6 sec of current and 4 sec at 85 Hz performed during low-intensity/low amplitude movements. 3 sessions / 14 days for 12 months
Device: whole-body electromyostimulation
3 sessions of 18 min/14 (1,5 x week)days over 12 months. 10 low-intensity/low amplitude exercises with electromyostimulation equipment with 85 Hz with periods of 6 sec of current and 4 sec of rest.
Other Names:
  • Electromusclestimulation, electrostimulation
  • Miha-bodytec
Placebo Comparator: wellness control group
Low intensity, low frequency exercise that focus on well being. 1 session/week for 10 weeks. 10 blocks of exercise with intermittent periods of 100 weeks of rest
Other: wellness control group.
Light physical exercise and relaxation program once a week in blocks of 10 weeks with breaks of 10 weeks between the blocks. The low-intensity, low-volume program was designed to avoid impact on our endpoints.
Other Names:
  • functional gymnastic, flexibility, relaxation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Mineral Density at the lumbar spine and femoral neck region
Time Frame: baseline - after 12 months
Bone Mineral Density as assessed by Dual Energy X-ray Absorptiometry
baseline - after 12 months
Falls
Time Frame: throughout the 12 month study period
Fall frequency and fall related injuries as assessed by the calendar method
throughout the 12 month study period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum strength (trunk and leg extension, grip strength)
Time Frame: baseline - after 12 months
baseline - after 12 months
Pain frequency and magnitude at various skeletal sites (including low back pain)
Time Frame: baseline - after 12 months
as assessed by questionnaires
baseline - after 12 months

Collaborators and Investigators

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

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

Behinderten- und Versehrten-Sportverband Bayern e.V.
Institute of Physical Education and Sports Sciences
City of Erlangen

Investigators

  • Principal Investigator: Wolfgang Kemmler, PhD, University of Erlangen-Nürnberg Medical School
  • Study Chair: Willi A Kalender, PHD, MD, University of Erlangen-Nürnberg Medical School
  • Study Director: Simon von Stengel, PhD, University of Erlangen-Nürnberg Medical School

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

Helpful Links

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

January 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (Estimate)

February 15, 2011

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMS-Bone-2011
  • EK_NO. 4184/2010
  • EMS_Bone_2011/2012 (Other Grant/Funding Number: IMP_2011)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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