Effect of Electromyostimulation on Bone
This study has been completed.
Sponsor:
University of Erlangen-Nürnberg Medical School
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
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| First Received Date ICMJE | February 14, 2011 | ||||||||||||
| Last Updated Date | December 6, 2012 | ||||||||||||
| Start Date ICMJE | January 2011 | ||||||||||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT01296776 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Effect of Electromyostimulation on Bone | ||||||||||||
| Official Title ICMJE | Effects of Whole-Body Electromyostimulation on Osteoporosis and Sarcopenia in Independently Living, Frail Elderly Females | ||||||||||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Phase 3 | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 78 | ||||||||||||
| Completion Date | December 2012 | ||||||||||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||||||
| Ages | 70 Years and older | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Germany | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01296776 | ||||||||||||
| Other Study ID Numbers ICMJE | EMS-Bone-2011, EK_NO. 4184/2010, EMS_Bone_2011/2012 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School | ||||||||||||
| Study Sponsor ICMJE | University of Erlangen-Nürnberg Medical School | ||||||||||||
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| Information Provided By | University of Erlangen-Nürnberg Medical School | ||||||||||||
| Verification Date | August 2012 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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