The Effect of 6 Months of Local Vibration Training in Institutionalized Elderly

NCT ID: NCT01499186

Last Updated: 2014-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-02-28

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.

Conditions

Osteoporosis; Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

There will be no participation in a training program. The control group will perform all measurements.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

The subjects of the vibration group will be subjected to local vibration training by the use of custom-made cylindrical vibrators. These subjects will perform all measurements.

Group Type: EXPERIMENTAL

Local Vibration

Intervention Type: OTHER

The subjects of the vibration group will be subjected to local vibration training by the use of custom-made cylindrical vibrators which will be placed on the hip and thigh. The subjects will apply the vibrations by themselves and they will learn how to follow the pre-programmed training program. Training sessions take place 5 times a week, during one year. The physiotherapist and the research assistant will attend the training session 1x/week. Training parameters will vary during the year to create a variable stimulus (frequency 40-80Hz and G-force 0.5-5g). The intervention group will perform all measurements.

Interventions

Local Vibration

The subjects of the vibration group will be subjected to local vibration training by the use of custom-made cylindrical vibrators which will be placed on the hip and thigh. The subjects will apply the vibrations by themselves and they will learn how to follow the pre-programmed training program. Training sessions take place 5 times a week, during one year. The physiotherapist and the research assistant will attend the training session 1x/week. Training parameters will vary during the year to create a variable stimulus (frequency 40-80Hz and G-force 0.5-5g). The intervention group will perform all measurements.

Intervention Type: OTHER

Other Intervention Names

Local vibration of muscle and bone

Eligibility Criteria

Inclusion Criteria

• Female;
• 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);

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sabine Verschueren, PhD, Prof

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

Faculty of Kinesiology and Rehabilitation Sciences

Leuven, Vlaams Brabant, Belgium

Countries

Belgium

References

Tankisheva E, Bogaerts A, Boonen S, Delecluse C, Jansen P, Verschueren SM. Effects of a Six-Month Local Vibration Training on Bone Density, Muscle Strength, Muscle Mass, and Physical Performance in Postmenopausal Women. J Strength Cond Res. 2015 Sep;29(9):2613-22. doi: 10.1519/JSC.0000000000000895.

Reference Type: DERIVED

PMID: 25992656 (View on PubMed)

Other Identifiers

ML7837

Identifier Type: -

Identifier Source: org_study_id