Effect of Electromyostimulation on Bone
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|ClinicalTrials.gov Identifier: NCT01296776|
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Osteopenia Sarcopenia Falls||Other: wellness control group. Device: whole-body electromyostimulation||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Effects of Whole-Body Electromyostimulation on Osteoporosis and Sarcopenia in Independently Living, Frail Elderly Females|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
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.
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.
- 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
- Falls [ Time Frame: throughout the 12 month study period ]Fall frequency and fall related injuries as assessed by the calendar method
- maximum strength (trunk and leg extension, grip strength) [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296776
|Institute of Medical Physics, University of Erlangen-Nürnberg|
|Erlangen, Germany, 91052|
|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|