Effect of Electromyostimulation on Bone

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteopenia, Sarcopenia, Falls

Intervention / Treatment
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* Other: wellness control group.
* Device: whole-body electromyostimulation


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: whole-body electromyostimulation<br>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<br>* 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.<br>* Other names: Miha-bodytec;|
| Placebo Comparator: wellness control group<br>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.<br>* 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.<br>* Other names: functional gymnastic, flexibility, relaxation.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum strength (trunk and leg extension, grip strength) |  | baseline - after 12 months | 
| Pain frequency and magnitude at various skeletal sites (including low back pain) | as assessed by questionnaires | baseline - after 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, whole-body electromyostimulation, bone mineral density, falls, physical fitness, pain