Clinical trial NCT00667667: Effects of Whole Body Vibration on Postmenopausal Risk-factors in Elderly Women
Official title: Effect of Whole Body Vibration Training on Two Different Devices on Osteoporotic Risk Factors in Postmenopausal Women. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Postmenopausal
Keywords: whole body vibration
exercise
postmenopausal
BMD
bone
elderly females
Caucasian race
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: Elsbeth-Bonhoff-Stiftung, Berlin
First posted: 2008-04-28
Enrollment: 108
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There is general agreement that physical exercise can positively influence osteoporotic fracture risk along two pathways: first by reducing the risk of falls via an improvement of fall related neuromuscular abilities; second by increasing bone strength.

Whole body vibration (WBV) training has recently been proposed as a new approach for prevention and treatment of osteoporosis. Animal studies have shown evidence that WBV may be an effective method to improve bone mass, architecture and strength. However, the results of human WBV training studies are rather heterogeneous.

In the Erlangen Longitudinal Vibration Study II (ELVIS II), a randomized, controlled 12 month lasting study the investigators determine the effect of a thrice weekly WBV training on two different devices on the osteoporotic risk factors: bone mineral density, falls and neuromuscular performance. Particular the investigators compare a bipedal vertical oscillating Plate with a plate which rotates around a central axis leading to a side-alternating loaning.


Eligibility criteria: Inclusion Criteria:

* females 60 - 75 years old
* caucasian race

Exclusion Criteria:

* CHD-diseases
* thrombosis, embolism
* fractures at lumbar spine or hip
* secondary osteoporosis
* hyperparathyroidism
* medication, diseases with impact on muscle or bone
* hip or knee implant

Primary outcomes:
measure: Bone Mineral Density
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: muscle strength
timeFrame: baseline, 12 months
measure: Quality of life
timeFrame: baseline, 12 month
measure: falls
timeFrame: daily over 12 month
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics, University of Erlangen-Nurnberg
Study officials:
affiliation: University of Erlangen-Nürnberg Medical School
name: Simon O von Stengel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instiute of Medical Physics
name: Wolfgang K Kemmler, PhD
role: STUDY_CHAIR
affiliation: University of Erlangen-Nürnberg Medical School
name: Willi A Kalender, Prof., PhD
role: STUDY_DIRECTOR
References:
citation: von Stengel S, Kemmler W, Kalender WA, Engelke K, Lauber D. Differential effects of strength versus power training on bone mineral density in postmenopausal women: a 2-year longitudinal study. Br J Sports Med. 2007 Oct;41(10):649-55; discussion 655. doi: 10.1136/bjsm.2006.033480. Epub 2007 Jun 5.
citation: Stengel SV, Kemmler W, Pintag R, Beeskow C, Weineck J, Lauber D, Kalender WA, Engelke K. Power training is more effective than strength training for maintaining bone mineral density in postmenopausal women. J Appl Physiol (1985). 2005 Jul;99(1):181-8. doi: 10.1152/japplphysiol.01260.2004. Epub 2005 Mar 3.
citation: Kemmler W, Lauber D, Weineck J, Hensen J, Kalender W, Engelke K. Benefits of 2 years of intense exercise on bone density, physical fitness, and blood lipids in early postmenopausal osteopenic women: results of the Erlangen Fitness Osteoporosis Prevention Study (EFOPS). Arch Intern Med. 2004 May 24;164(10):1084-91. doi: 10.1001/archinte.164.10.1084.