Whole Body Vibration Exercise Training for Institutionalized Elderly

Geriatric Disorder Clinical Trial

Official title:

The Effects of Whole Body Vibration Exercise Training on Physical Functioning and Falls in Institutionalized Elderly: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01735682
• Other study ID #: HSEARS20120730001
• Status: Recruiting
• Phase: N/A
• First received: November 20, 2012
• Last updated: May 29, 2014
• Start date: November 2012
• Est. completion date: October 2015

Study information

• Verified date: May 2014
• Source: The Hong Kong Polytechnic University
• Contact: Philip Chan, MSc
• Phone: 852-9851-1382
• Email: cfl083[@]gmail.com
• Is FDA regulated: No
• Health authority: Hong Kong: Research Office, The Hong Kong Polytechnic University
• Study type: Interventional

Clinical Trial Summary

It is hypothesized that whole body vibration exercise group will have significantly more improvement in physical functioning and reduction in fall incidence among institutionalized elderly, compared with conventional exercise group and control group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: October 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Functional Ambulation Category 1 to 4

• able to understand simple verbal commands

• able to tolerate intermittent physical activity for at least 45 minutes

• able to perform knee flexion >45 degree

• able to stand with or without support for 1 minute or more

Exclusion Criteria:

• peripheral vascular disease

• any symptoms associated with vestibular disorder

• any contraindications to exercise (e.g. unstable angina)

• any serious illnesses that preclude participation (e.g. cancer)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Geriatric Disorder

Intervention

Device:
• Whole body vibration
The vibration frequency and amplitude used will be 30-40 Hz and 1mm, respectively. The total exposure to the vibration stimulation is 4 minutes.

Behavioral:
• Conventional exercise
The conventional exercise training involves upper limb and lower limb strengthening exercises using sandbags.
• Control
The control treatment involves exercises of the upper limbs.

Locations

Country	Name	City	State
Hong Kong	Shatin Hospital	Shatin	New Territories

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Shatin Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (2)

Bautmans I, Van Hees E, Lemper JC, Mets T. The feasibility of Whole Body Vibration in institutionalised elderly persons and its influence on muscle performance, balance and mobility: a randomised controlled trial [ISRCTN62535013]. BMC Geriatr. 2005 Dec 22;5:17. — View Citation

Bruyere O, Wuidart MA, Di Palma E, Gourlay M, Ethgen O, Richy F, Reginster JY. Controlled whole body vibration to decrease fall risk and improve health-related quality of life of nursing home residents. Arch Phys Med Rehabil. 2005 Feb;86(2):303-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed-Up-and-Go test	It is a measure of functional mobility	week 0	No
Primary	Timed-up-and-go test		week 8	No
Secondary	Berg balance scale		week 0	No
Secondary	Berg balance scale		week 8	No
Secondary	leg extension strength		week 0	No
Secondary	leg extension strength		week 8	No
Secondary	shoulder abduction strength		week 0	No
Secondary	shoulder abduction strength		week 8	No
Secondary	elbow flexion strength		week 0	No
Secondary	elbow flexion strength		week 8	No
Secondary	six minute walk test		week 0	No
Secondary	six minute walk test		week 8	No
Secondary	Activities-specific balance confidence scale		week 0	No
Secondary	Activities-specific balance confidence scale		week 8	No
Secondary	Quick DASH	A measure of upper limb function	week 0	No
Secondary	Quick DASH		week 8	No
Secondary	Physiological Profile Assessment: short form		week 0	No
Secondary	Physiological Profile Assessment: short form		week 8	No
Secondary	falls incidence		Daily from week 0 to 12 months after termination of treatment/control period	No