Skip to main content
OpenTrials
Completed

NCT Number: NCT01296776

Effect of Electromyostimulation on Bone

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteopenia Atrophy Behavior Bone Diseases Bone Diseases, Metabolic Falls Metabolic Diseases Motor Activity Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

70 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Medical Physics, University of Erlangen-Nürnberg

Erlangen, 91052, Germany

Who can participate

Healthy volunteers accepted: Yes

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

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,

Treatment and study plan

wellness control group.

Other

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.

whole-body electromyostimulation

Device

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

Primary outcomes

  1. 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

  2. Falls

    Time frame: throughout the 12 month study period

    Fall frequency and fall related injuries as assessed by the calendar method

Secondary outcomes

  1. maximum strength (trunk and leg extension, grip strength)

    Time frame: baseline - after 12 months

  2. Pain frequency and magnitude at various skeletal sites (including low back pain)

    Time frame: baseline - after 12 months

    as assessed by questionnaires

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 15, 2011
Registry last updated
Dec 2, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.