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Clinical Trials/NCT01499186
NCT01499186
Completed
N/A

The Effect of 6 Months of Local Vibration Training of the Thigh and Hip on Muscle Strength, Muscle Mass, Bone Density, Bone Structure and Functionality in Institutionalized Elderly.

Universitaire Ziekenhuizen KU Leuven1 site in 1 country50 target enrollmentJanuary 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Osteoporosis
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
50
Locations
1
Primary Endpoint
Bone mineral density hip (change in bone mineral density hip)
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

This randomized controlled intervention study in institutionalized elderly investigates the effect of 6 months of local vibration therapy applied on the thigh and hip on muscle strength, muscle mass, bone density, and functionality.

Detailed Description

As the world population ages, osteoporosis (skeletal fragility) and sarcopenia (decline in muscle mass and muscle strength) are becoming increasingly important public health concerns. Both osteoporosis and sarcopenia contribute to an increased fall risk and an increased number of hip and vertebral fractures. Clearly, the clinical and economic consequences of osteoporosis and sarcopenia, and the resulting falls and fractures, call for major efforts to search for efficient and feasible interventions to prevent or reverse bone and muscle loss. The present project is intended to partly meet this need. Whole Body Vibration (WBV) training might be an efficient training method. During WBV the subject stands on a platform that generates vertical sinusoidal vibrations. These mechanical stimuli are transmitted to the body where they stimulate the bone and reflexive muscle contractions will be generated. In previous studies performed by the same group, the investigators found that WBV training (frequency 30-40Hz, peak acceleration 3-10g) can be seen as an efficient alternative for strength training, both in the young sedentary as well as in the elderly population. Additionally, the investigators were able to show that 6 months vibration training in elderly females resulted in a net benefit of about 1.5% in bone mineral density of the hip compared with controls. Finally, the investigators have recently shown that long-term vibration training results in an increase of quadriceps muscle mass. From the above it appears that vibration therapy could be a plausible candidate as an efficient combination therapy for elderly subjects at risk for osteoporosis and sarcopenia and, by implication, the therapy might help to reduce the number of falls and fractures. However, many questions regarding vibration as a therapy still need to be answered in order to optimize both the efficacy and safety of its application. The application methods of vibration therapy should be optimized to be applicable in a broader range of subjects as well as to deliver the stimuli more targeted to specific regions of interest. Whole body vibration in its present form (subjects standing on a vibrating platform) is inadequate for a large part of the elderly population (e.g., subjects with osteoarthritis at the knee, wheelchair bound subjects, bedridden subjects). Additionally, the transmission of the vibration stimulus from the feet to the hip during WBV is probably insufficient to provoke optimal adaptations at this level. Delivering the vibration stimuli locally (i.e. more targeted) at those regions at risk for fractures or in need for muscle strengthening might be an efficient alternative application method. The main aim of this pilot research is to obtain data that should allow the investigators to optimize the efficacy and safety of the vibration excitation pattern as well as to optimize the application method. With the ageing of the world population and the predicted rise in fall and fracture rates, appropriate strategies to combat muscle and bone loss will have far reaching implications in containing future health care expenditure for the elderly and in reducing the need for institutionalized care.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
February 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Above 65 years of age;
  • Institutionalized in a nursing home, service flat or cloistered community;
  • Not on bone-active agents;
  • Approval for participation in the study after a medical screening by a doctor. The general practitioner will also be contacted for approving the participation of the patient;
  • Signed informed consent.

Exclusion Criteria

  • Musculoskeletal disease;
  • Terminal illness, recent myocardial infarction or unstable cardiovascular conditions;
  • Participation in resistance training during the past 24 months;
  • Metallic implants (e.g. prothesis);

Outcomes

Primary Outcomes

Bone mineral density hip (change in bone mineral density hip)

Time Frame: baseline and after 6 months

Bone mineral density of the total hip will be determined by dual - energy x - ray absorptiometry (Hologic, Waltham, MA, USA).

Secondary Outcomes

  • Functionality (change in functionality)(baseline and 6 months)
  • Physical performance (change in physical performance)(baseline and 6 months)
  • Muscle mass (change in muscle mass)(baseline and 6 months)
  • Muscle strength and muscle power (change in muscle strength and power)(baseline and 6 months)

Study Sites (1)

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