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Effect of Electromyostimulation on Bone

Primary Purpose

Osteopenia, Sarcopenia, Falls

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
wellness control group.
whole-body electromyostimulation
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteopenia focused on measuring exercise, whole-body electromyostimulation, bone mineral density, falls, physical fitness, pain

Eligibility Criteria

70 Years - 99 Years (Older Adult)FemaleAccepts 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,

Sites / Locations

  • Institute of Medical Physics, University of Erlangen-Nürnberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

whole-body electromyostimulation

wellness control group

Arm 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

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

Outcomes

Primary Outcome Measures

Bone Mineral Density at the lumbar spine and femoral neck region
Bone Mineral Density as assessed by Dual Energy X-ray Absorptiometry
Falls
Fall frequency and fall related injuries as assessed by the calendar method

Secondary Outcome Measures

maximum strength (trunk and leg extension, grip strength)
Pain frequency and magnitude at various skeletal sites (including low back pain)
as assessed by questionnaires

Full Information

First Posted
February 14, 2011
Last Updated
December 1, 2015
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
City of Erlangen, Behinderten- und Versehrten-Sportverband Bayern e.V., Institute of Physical Education and Sports Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01296776
Brief Title
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

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
City of Erlangen, Behinderten- und Versehrten-Sportverband Bayern e.V., Institute of Physical Education and Sports Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia, Sarcopenia, Falls
Keywords
exercise, whole-body electromyostimulation, bone mineral density, falls, physical fitness, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
whole-body electromyostimulation
Arm Type
Active Comparator
Arm 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
Arm Title
wellness control group
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
wellness control group.
Other Intervention Name(s)
functional gymnastic, flexibility, relaxation.
Intervention Description
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
Device
Intervention Name(s)
whole-body electromyostimulation
Other Intervention Name(s)
Electromusclestimulation, electrostimulation, Miha-bodytec
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bone Mineral Density at the lumbar spine and femoral neck region
Description
Bone Mineral Density as assessed by Dual Energy X-ray Absorptiometry
Time Frame
baseline - after 12 months
Title
Falls
Description
Fall frequency and fall related injuries as assessed by the calendar method
Time Frame
throughout the 12 month study period
Secondary Outcome Measure Information:
Title
maximum strength (trunk and leg extension, grip strength)
Time Frame
baseline - after 12 months
Title
Pain frequency and magnitude at various skeletal sites (including low back pain)
Description
as assessed by questionnaires
Time Frame
baseline - after 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willi A Kalender, PhD, MD
Organizational Affiliation
University of Erlangen-Nürnberg Medical School
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wolfgang Kemmler, PhD
Organizational Affiliation
University of Erlangen-Nürnberg Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simon von Stengel, PhD
Organizational Affiliation
University of Erlangen-Nürnberg Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Medical Physics, University of Erlangen-Nürnberg
City
Erlangen
ZIP/Postal Code
91052
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20555279
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.
Results Reference
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PubMed Identifier
20101013
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.
Results Reference
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PubMed Identifier
20306017
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.
Results Reference
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Effect of Electromyostimulation on Bone

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