Effect of Electromyostimulation on Bone

Sarcopenia Clinical Trial

Official title:

Effects of Whole-Body Electromyostimulation on Osteoporosis and Sarcopenia in Independently Living, Frail Elderly Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296776
• Other study ID #: EMS-Bone-2011
• Secondary ID: EK_NO. 4184/2010
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2011
• Last updated: December 1, 2015
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: August 2012
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Office for Radiation Protection
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 70 Years to 99 Years

Eligibility

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,

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Falls
• Osteopenia
• Sarcopenia

Intervention

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.

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.

Locations

Country	Name	City	State
Germany	Institute of Medical Physics, University of Erlangen-Nürnberg	Erlangen

Sponsors (4)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Behinderten- und Versehrten-Sportverband Bayern e.V., City of Erlangen, Institute of Physical Education and Sports Sciences

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Falls	Fall frequency and fall related injuries as assessed by the calendar method	throughout the 12 month study period	No
Secondary	maximum strength (trunk and leg extension, grip strength)		baseline - after 12 months	No
Secondary	Pain frequency and magnitude at various skeletal sites (including low back pain)	as assessed by questionnaires	baseline - after 12 months	No

External Links

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