Effect of Electromyostimulation on Bone

University of Erlangen-Nürnberg Medical School

Status and phase: Completed; Phase 3

Conditions: Osteopenia; Falls; Sarcopenia

Treatments: Device: whole-body electromyostimulation; Other: wellness control group.

Study type: Interventional

Funder types: Other

Identifiers

NCT01296776

EMS-Bone-2011

EMS_Bone_2011/2012 (Other Grant/Funding Number)

EK_NO. 4184/2010

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: Female

Ages: 70 to 99 years old

Volunteers: Accepts Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 2 patient groups, including a placebo group

whole-body electromyostimulation

Active Comparator group

Description:

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

Treatment:

Device: whole-body electromyostimulation

wellness control group

Placebo Comparator group

Description:

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

Treatment:

Other: wellness control group.