Text Size

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
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteopenia
Sarcopenia
Falls
 Other: wellness control group.
Device: whole-body electromyostimulation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Whole-Body Electromyostimulation on Osteoporosis and Sarcopenia in Independently Living, Frail Elderly Females

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 78
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: functional gymnastic, flexibility, relaxation.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296776

Locations
Germany
Institute of Medical Physics, University of Erlangen-Nürnberg
Erlangen, Germany, 91052
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
City of Erlangen
Behinderten und Rehabilitations-Sportverband Bayern
Institute of Physical Education and Sports Sciences
Investigators
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
  More Information

Additional Information:
Web page of the Institute of Medical Physics/Osteoporosis Research Center, University of Erlangen  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Wolfgang Kemmler, Professor Dr., University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01296776     History of Changes
Other Study ID Numbers: EMS-Bone-2011, EK_NO. 4184/2010, EMS_Bone_2011/2012
Study First Received: February 14, 2011
Last Updated: December 6, 2012
Health Authority: Germany: Ethics Commission
Germany: Federal Office for Radiation Protection

Keywords provided by University of Erlangen-Nürnberg Medical School:
exercise
whole-body electromyostimulation
bone mineral density
 falls
physical fitness
pain

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Sarcopenia
Bone Diseases
Musculoskeletal Diseases
Muscular Atrophy
Neuromuscular Manifestations
 Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013