Clinical trial NCT01734083: Whole Body Vibration Exercise for Elderly With Cognitive Impairments
Official title: The Effects of Whole Body Vibration Exercise Training on Physical Functioning and Falls in Community-dwelling Elderly With Cognitive Impairments
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Keywords: rehabilitation
exercise
fall
muscle
vibration
mobility
cognition
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2012-11-27
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Timed-up-and-go test
timeFrame: week 0
measure: Timed-up-and-go test
timeFrame: week 9
measure: Timed-up-and-go test
timeFrame: week 21
Secondary outcomes:
measure: Berg balance scale
timeFrame: week 0
measure: Berg balance scale
timeFrame: week 9
measure: Berg balance scale
timeFrame: week 21
measure: Activities-specific balance confidence scale
timeFrame: week 0
measure: Activities-specific balance confidence scale
timeFrame: week 9
measure: Activities-specific balance confidence scale
timeFrame: week 21
measure: five times sit-to-stand test
timeFrame: week 0
measure: five times sit-to-stand test
timeFrame: week 9
measure: five times sit-to-stand test
timeFrame: week 21
measure: Mini-Mental State Examination
timeFrame: week 0
measure: Mini-Mental State Examination
timeFrame: week 9
measure: Mini-Mental State Examination
timeFrame: week 21
measure: Quality of Life in Alzheimer's disease
timeFrame: week 0
measure: Quality of Life in Alzheimer's disease
timeFrame: week 9
measure: Quality of Life in Alzheimer's disease
timeFrame: week 21
measure: incidence of falls
timeFrame: daily starting from week 0 to week 33
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Jockey Club Centre for Positive Ageing
state: New Territories
Study officials:
affiliation: Hong Kong Polytechnic University
name: Marco Pang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1186/1471-2318-5-17.
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. doi: 10.1016/j.apmr.2004.05.019.