Effect of Electromyostimulation on Bone

This study has been completed.

Sponsor:

Collaborators:

City of Erlangen

Behinderten- und Versehrten-Sportverband Bayern e.V.

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 1, 2015

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:

MedlinePlus related topics: Bone Density Exercise and Physical Fitness Falls

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 to 99 Years (Senior)
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

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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 Versehrten-Sportverband Bayern e.V.

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:

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, Häberle 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.

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.


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 1, 2015
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:


Sarcopenia Bone Diseases, Metabolic Muscular Atrophy Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases	Atrophy Pathological Conditions, Anatomical Signs and Symptoms Bone Diseases Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 26, 2016

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