Whole Body Vibration Exercise for Elderly With Cognitive Impairments

Dementia Clinical Trial

Official title:

The Effects of Whole Body Vibration Exercise Training on Physical Functioning and Falls in Community-dwelling Elderly With Cognitive Impairments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01734083
• Other study ID #: HSEARS20120929006
• Status: Recruiting
• Phase: N/A
• First received: November 21, 2012
• Last updated: November 26, 2012
• Start date: November 2012
• Est. completion date: July 2015

Study information

• Verified date: November 2012
• Source: The Hong Kong Polytechnic University
• Contact: Marco Pang, PhD
• Phone: 852-2766-7156
• Email: Marco.Pang[@]polyu.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The whole body vibration exercise group will have significantly more improvement in mobility, muscle strength, balance, balance confidence, and cognitive function with a lower fall rate than the control group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: July 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• a diagnosis of mild or moderate dementia, with a Clinical Dementia Rating (CDR) of 1 to 2, and a Cantonese Mini-mental State Examination (CMMSE) score at 10 or above but below the local cutoff for dementia (18-22, depending on education level)

• able to stand for at least 1 minute with or without hand support

• living in the community

• having an informed consent (from the primary caregiver)

Exclusion Criteria:

• significant musculoskeletal conditions (e.g. amputations)

• metal implants in the lower extremity

• recent fracture in the lower extremity

• vestibular disorders

• peripheral vascular disease

• other serious illnesses or contraindications to exercise.

Study Design

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

Related Conditions & MeSH terms

• Cognition Disorders
• Dementia

Intervention

Device:
• Whole body vibration exercise
The whole body vibration will be delivered by a platform that can generate vibration signals (Powerplate). The total duration of vibration exposure per session will range from 4 to 6 minutes. The vibration bouts (30-45 seconds per bout) will be interspersed with a 1 to 2 minutes of rest period. While standing on the vibration platform, subjects will be instructed to repeat two exercises: (1) static semi-squats, and (2) dynamic semi-squats.

Behavioral:
• Conventional exercise
The conventional exercise training will involve a combination of upper limb and lower limb stretching and strengthening exercises, balance training, and gait re-education.

Locations

Country	Name	City	State
Hong Kong	Jockey Club Centre for Positive Ageing	Shatin	New Territories

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Chinese University of 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	A measure of functional mobility	week 0	No
Primary	Timed-up-and-go test		week 9	No
Primary	Timed-up-and-go test		week 21	No
Secondary	Berg balance scale		week 0	No
Secondary	Berg balance scale		week 9	No
Secondary	Berg balance scale		week 21	No
Secondary	Activities-specific balance confidence scale		week 0	No
Secondary	Activities-specific balance confidence scale		week 9	No
Secondary	Activities-specific balance confidence scale		week 21	No
Secondary	five times sit-to-stand test		week 0	No
Secondary	five times sit-to-stand test		week 9	No
Secondary	five times sit-to-stand test		week 21	No
Secondary	Mini-Mental State Examination		week 0	No
Secondary	Mini-Mental State Examination		week 9	No
Secondary	Mini-Mental State Examination		week 21	No
Secondary	Quality of Life in Alzheimer's disease		week 0	No
Secondary	Quality of Life in Alzheimer's disease		week 9	No
Secondary	Quality of Life in Alzheimer's disease		week 21	No
Secondary	incidence of falls	Incidence of falls will be recorded by using fall diaries.	daily starting from week 0 to week 33	No