Effect of Electromyostimulation on Bone

NCT01296776 | Completed Phase 3 DMC

• 3 other identifiers: EMS-Bone-2011EK_NO. 4184/2010EMS_Bone_2011/2012
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopenia; Sarcopenia; Falls

Keywords

exercise; whole-body electromyostimulation; bone mineral density; falls; physical fitness; pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

whole-body electromyostimulation

ACTIVE COMPARATOR

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

wellness control group

PLACEBO COMPARATOR

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.

Interventions

wellness control group. 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.

Also known as: functional gymnastic, flexibility, relaxation.

wellness control group

whole-body electromyostimulation 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.

Also known as: Electromusclestimulation, electrostimulation, Miha-bodytec

whole-body electromyostimulation

Eligibility Criteria

• Age: 70 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• female gender
• years and older
• osteopenia according to WHO
• BMI \< 24 kg/m2
• living independently in the area of Erlangen-Nurnberg

You may not qualify if:

• 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,

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• City of Erlangen: collaborator
• Behinderten- und Versehrten-Sportverband Bayern e.V.: collaborator
• Institute of Physical Education and Sports Sciences: collaborator

Study Sites (1)

Institute of Medical Physics, University of Erlangen-Nürnberg

Erlangen, 91052, Germany

Location

Related Publications (3)

• 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.

  PMID: 20555279 BACKGROUND

• 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.

  PMID: 20101013 BACKGROUND

• 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.

  PMID: 20306017 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic; Sarcopenia; Motor Activity; Pain

Interventions

Pliability

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Willi A Kalender, PhD, MD

  University of Erlangen-Nürnberg Medical School

  STUDY CHAIR

• Wolfgang Kemmler, PhD

  University of Erlangen-Nürnberg Medical School

  PRINCIPAL INVESTIGATOR

• Simon von Stengel, PhD

  University of Erlangen-Nürnberg Medical School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 15, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 2, 2015

Record last verified: 2012-08

Locations

DE (1)