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

NCT01499186 | Completed

• 1 other identifier: ML7837
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Sarcopenia

Keywords

Local vibration, elderly, bone, muscle, functionality

Outcome Measures

Primary Outcomes (1)

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

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

  baseline and after 6 months

Secondary Outcomes (4)

• 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 Arms (2)

Control group

NO INTERVENTION

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

Intervention group

EXPERIMENTAL

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.

Other: Local Vibration

Interventions

Local Vibration 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.

Also known as: Local vibration of muscle and bone

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Faculty of Kinesiology and Rehabilitation Sciences

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 25992656 DERIVED

MeSH Terms

Conditions

Osteoporosis; Sarcopenia

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; 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

Study Officials

• Sabine Verschueren, PhD, Prof

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: December 26, 2011
• Study Start: January 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 18, 2014

Record last verified: 2013-12

Locations

BE (1)