NCT01296776|CompletedPhase 3DMC
Effect of Electromyostimulation on Bone
Effects of Whole-Body Electromyostimulation on Osteoporosis and Sarcopenia in Independently Living, Frail Elderly Females
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · IMP_2011
interventional
78
1 country
1
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)Study Completion
December 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
February 14, 2011
Actual (reported)February 15, 2011
Actual (reported)December 2012
Actual (reported)December 2012
Actual (reported)Bone Mineral Density at the lumbar spine and femoral neck region
Bone Mineral Density as assessed by Dual Energy X-ray Absorptiometry
baseline - after 12 months
Falls
Fall frequency and fall related injuries as assessed by the calendar method
throughout the 12 month study period
maximum strength (trunk and leg extension, grip strength)
baseline - after 12 months
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
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
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.
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.
Institute of Medical Physics, University of Erlangen-Nürnberg
Erlangen, 91052, Germany
Kemmler W, Schliffka R, Mayhew JL, von Stengel S. Effects of whole-body electromyostimulation on resting metabolic rate, body composition, and maximum strength in postmenopausal women: the Training and ElectroStimulation Trial. J Strength Cond Res. 2010 Jul;24(7):1880-7. doi: 10.1519/JSC.0b013e3181ddaeee.
Kemmler W, von Stengel S, Engelke K, Haberle L, Kalender WA. Exercise effects on bone mineral density, falls, coronary risk factors, and health care costs in older women: the randomized controlled senior fitness and prevention (SEFIP) study. Arch Intern Med. 2010 Jan 25;170(2):179-85. doi: 10.1001/archinternmed.2009.499.
Willi A Kalender, PhD, MD
University of Erlangen-Nürnberg Medical School
Wolfgang Kemmler, PhD
University of Erlangen-Nürnberg Medical School
Simon von Stengel, PhD
University of Erlangen-Nürnberg Medical School
78 participants (actual enrollment reported by the registry).
First Submitted
February 14, 2011
First Posted
February 15, 2011
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Effectiveness of Creatine Supplementation and Exercise on Muscle and Bone
Pain frequency and magnitude at various skeletal sites (including low back pain)
baseline - after 12 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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von Stengel S, Kemmler W, Engelke K, Kalender WA. Effects of whole body vibration on bone mineral density and falls: results of the randomized controlled ELVIS study with postmenopausal women. Osteoporos Int. 2011 Jan;22(1):317-25. doi: 10.1007/s00198-010-1215-4. Epub 2010 Mar 20.
Primary Completion
December 2012
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
December 2, 2015
Record last verified: 2012-08
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Source: ClinicalTrials.gov.
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