Effect of Electromyostimulation on Bone

• Sponsor: University of Erlangen-Nürnberg Medical School (Other)
• Overall Status: Completed
• CT.gov ID: NCT01296776
• Collaborator: City of Erlangen (Other), Behinderten- und Versehrten-Sportverband Bayern e.V. (Other), Institute of Physical Education and Sports Sciences (Other)
• Enrollment: 78
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteopenia; Sarcopenia; Falls	Other: wellness control group.; Device: whole-body electromyostimulation	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Whole-Body Electromyostimulation on Osteoporosis and Sarcopenia in Independently Living, Frail Elderly Females
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: functional gymnastic, flexibility, relaxation.

Outcome Measures

Primary Outcome Measures

1. Bone Mineral Density at the lumbar spine and femoral neck region [baseline - after 12 months]

   Bone Mineral Density as assessed by Dual Energy X-ray Absorptiometry

2. Falls [throughout the 12 month study period]

   Fall frequency and fall related injuries as assessed by the calendar method

Secondary Outcome Measures

1. maximum strength (trunk and leg extension, grip strength) [baseline - after 12 months]

2. Pain frequency and magnitude at various skeletal sites (including low back pain) [baseline - after 12 months]

   as assessed by questionnaires

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years to 99 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Web page of the Institute of Medical Physics/Osteoporosis Research Center, University of Erlangen

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
• Other Study ID Numbers: EMS-Bone-2011; EK_NO. 4184/2010; EMS_Bone_2011/2012
• First Posted: Feb 15, 2011
• Last Update Posted: Dec 2, 2015
• Last Verified: Aug 1, 2012

• Keywords provided by Wolfgang Kemmler, Professor Dr., 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

Study Results

No Results Posted as of Dec 2, 2015