Effect of Electromyostimulation on Bone

NCT ID: NCT01296776

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-12-31

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.

Detailed Description

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Conditions

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Osteopenia Sarcopenia Falls

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

whole-body electromyostimulation

Intervention Type DEVICE

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.

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

Group Type PLACEBO_COMPARATOR

wellness control group.

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type DEVICE

Other Intervention Names

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functional gymnastic, flexibility, relaxation. Electromusclestimulation, electrostimulation Miha-bodytec

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,
Minimum Eligible Age

70 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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City of Erlangen

UNKNOWN

Sponsor Role collaborator

Behinderten- und Versehrten-Sportverband Bayern e.V.

OTHER

Sponsor Role collaborator

Institute of Physical Education and Sports Sciences

OTHER

Sponsor Role collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Wolfgang Kemmler

Professor Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Willi A Kalender, PhD, MD

Role: STUDY_CHAIR

University of Erlangen-Nürnberg Medical School

Wolfgang Kemmler, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Erlangen-Nürnberg Medical School

Simon von Stengel, PhD

Role: STUDY_DIRECTOR

University of Erlangen-Nürnberg Medical School

Locations

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Institute of Medical Physics, University of Erlangen-Nürnberg

Erlangen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 20555279 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20101013 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20306017 (View on PubMed)

Other Identifiers

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EK_NO. 4184/2010

Identifier Type: -

Identifier Source: secondary_id

EMS_Bone_2011/2012

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EMS-Bone-2011

Identifier Type: -

Identifier Source: org_study_id