Condition category
Injury, Occupational Diseases, Poisoning
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
17/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ross Pollock

ORCID ID

Contact details

King's College London
Division of Applied Biomedical Research
London
WC2R 2LS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5370

Study information

Scientific title

The effect of whole body vibration therapy on older people: a single centre randomised intervention trial

Acronym

Study hypothesis

Exercise based programmes reduce the risk of falling and can improve quality of life for older people, but they are unlikely to increase bone strength. Although muscles become weaker with ageing, strengthening exercises are effective in all age groups but require a sustained effort over long periods of time. Many people, irrespective of age, do not enjoy exercise and also the type of exercise necessary to increase muscle and bone strength is difficult for the more frail to perform.

Whole body vibration (WBV) has been reported to increase muscle strength and power, bone mineral density, balance and speed of movement – all factors affecting the risk of both falling and sustaining a subsequent injury. The literature suggests that it is more effective for older and frail people than young highly trained ones. As relatively little effort is required for short periods the technique has real potential for improving the physical status of older people.

We have therefore incorporated WBV exercise into a strength and balance exercise class run for older individuals who have had multiple falls. This randomised controlled trial is conducted over 8 weeks with measures of strength, balance, bone strength and health related quality of life being made at the start of the class, 4 weeks and at the end of the class. In addition a number of subjects will have a 6-month follow up.

Ethics approval

St Thomas' Hospital Research Ethics Committee approved on the 9th June 2008 (ref: 08/H0802/65)

Study design

Single centre randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Age and ageing

Intervention

Intervention group: performing WBV for 5 mins at the end of the exercise class at a frequency of 15 - 30 Hz and amplitude of 1 - 4 mm
Control group: exercise class only

The exercise class runs 3 x per week for 8 weeks. The WBV group perform an additional 5 minutes of WBV at the end of each class. A follow up is performed 6 months after completion of the class.

Study entry: single randomisation only.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Physiological Profile Assessment, measured before and immediately upon completion of the exercise class

Secondary outcome measures

1. Six-metre walk test, measured at baseline, 4 and 8 weeks
2. Berg Balance Scale, measured at baseline, 4 and 8 weeks
3. Blood Analysis for markers of bone turnover, measured at baseline and 8 weeks
4. Falls Efficacy Scale - International (FES-I), measured at baseline and 8 weeks
5. 12-item short form health survey (SF12) version 2, measured at baseline and 8 weeks
6. Timed Up and Go Test, measured at baseline, 4weeks and 8 weeks

Overall trial start date

01/09/2007

Overall trial end date

30/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women of all ages
2. Having had one or more falls
3. Attending the strength and balance group run in the Older Person Assessment Unit at Guy's Hospital

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 70

Participant exclusion criteria

1. Artificial joints
2. Mini-mental state examination (MSSE) less than 20

Recruitment start date

01/09/2007

Recruitment end date

30/05/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London
London
WC2R 2LS
United Kingdom

Sponsor information

Organisation

Kings College London (UK)

Sponsor details

Strand
London
WC2R 2LS
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk/

Funders

Funder type

Charity

Funder name

Research into Ageing (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22324058

Publication citations

  1. Results

    Pollock RD, Martin FC, Newham DJ, Whole-body vibration in addition to strength and balance exercise for falls-related functional mobility of frail older adults: a single-blind randomized controlled trial., Clin Rehabil, 2012, 26, 10, 915-923, doi: 10.1177/0269215511435688.

Additional files

Editorial Notes