Clinical trial NCT01296776: Effect of Electromyostimulation on Bone
Official title: Effects of Whole-Body Electromyostimulation on Osteoporosis and Sarcopenia in Independently Living, Frail Elderly Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteopenia
Sarcopenia
Falls
Keywords: exercise
whole-body electromyostimulation
bone mineral density
falls
physical fitness
pain
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: City of Erlangen
name: Behinderten- und Versehrten-Sportverband Bayern e.V.
name: Institute of Physical Education and Sports Sciences
First posted: 2011-02-15
Enrollment: 78
Sex: FEMALE
Minimum age (years): 70
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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,

Primary outcomes:
measure: Bone Mineral Density at the lumbar spine and femoral neck region
timeFrame: baseline - after 12 months
measure: Falls
timeFrame: throughout the 12 month study period
Secondary outcomes:
measure: maximum strength (trunk and leg extension, grip strength)
timeFrame: baseline - after 12 months
measure: Pain frequency and magnitude at various skeletal sites (including low back pain)
timeFrame: baseline - after 12 months
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics, University of Erlangen-Nürnberg
Study officials:
affiliation: University of Erlangen-Nürnberg Medical School
name: Willi A Kalender, PhD, MD
role: STUDY_CHAIR
affiliation: University of Erlangen-Nürnberg Medical School
name: Wolfgang Kemmler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Erlangen-Nürnberg Medical School
name: Simon von Stengel, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
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.