Effect of Electromyostimulation on Bone

Phase 3

Completed

• Conditions: Osteopenia; Falls; Sarcopenia
• Interventions: Device: whole-body electromyostimulation; Other: wellness control group.

• Registration Number: NCT01296776
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-14
• Study First Posted: 2011-02-15
• Status Verified: 2012-08
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
whole-body electromyostimulation	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
wellness control group	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

Primary Outcome Measures

Name	Time	Method
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
Falls	throughout the 12 month study period	Fall frequency and fall related injuries as assessed by the calendar method

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Medical Physics, University of Erlangen-Nürnberg; 🇩🇪 Erlangen, Germany