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Effect of Electromyostimulation on Bone

This study has been completed.
Sponsor:
Collaborators:
City of Erlangen
Behinderten und Rehabilitations-Sportverband Bayern
Institute of Physical Education and Sports Sciences
Information provided by (Responsible Party):
Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01296776
First received: February 14, 2011
Last updated: December 6, 2012
Last verified: August 2012

February 14, 2011
December 6, 2012
January 2011
December 2012   (final data collection date for primary outcome measure)
  • Bone Mineral Density at the lumbar spine and femoral neck region [ Time Frame: baseline - after 12 months ] [ Designated as safety issue: No ]
    Bone Mineral Density as assessed by Dual Energy X-ray Absorptiometry
  • Falls [ Time Frame: throughout the 12 month study period ] [ Designated as safety issue: No ]
    Fall frequency and fall related injuries as assessed by the calendar method
Same as current
Complete list of historical versions of study NCT01296776 on ClinicalTrials.gov Archive Site
  • maximum strength (trunk and leg extension, grip strength) [ Time Frame: baseline - after 12 months ] [ Designated as safety issue: No ]
  • Pain frequency and magnitude at various skeletal sites (including low back pain) [ Time Frame: baseline - after 12 months ] [ Designated as safety issue: No ]
    as assessed by questionnaires
Same as current
Not Provided
Not Provided
 
Effect of Electromyostimulation on Bone
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • Osteopenia
  • Sarcopenia
  • Falls
  • 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 Name: functional gymnastic, flexibility, relaxation.
  • 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
  • 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
    Intervention: Device: whole-body electromyostimulation
  • 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
    Intervention: Other: wellness control group.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
December 2012
December 2012   (final data collection date for primary outcome measure)

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,
Female
70 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01296776
EMS-Bone-2011, EK_NO. 4184/2010, EMS_Bone_2011/2012
Yes
Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
  • City of Erlangen
  • Behinderten und Rehabilitations-Sportverband Bayern
  • Institute of Physical Education and Sports Sciences
Study Chair: Willi A Kalender, PhD, MD University of Erlangen-Nürnberg Medical School
Principal Investigator: Wolfgang Kemmler, PhD University of Erlangen-Nürnberg Medical School
Study Director: Simon von Stengel, PhD University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP