Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001063707
Ethics application status
Approved
Date submitted
19/09/2013
Date registered
24/09/2013
Date last updated
24/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a whole body vibration training program for preventing falls in institutionalised elderly with fear of falling.
Scientific title
Among older people living in a nursing home does the use of whole body vibration lead to improvements in balance, strength, fear of falling, quality of life and a reduction in falls risk compared to a placebo group.
Secondary ID [1] 283251 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls risk 290126 0
Strength 290149 0
Balance 290150 0
Fear of falling 290151 0
Quality of life 290152 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290508 290508 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 290509 290509 0 0
Other injuries and accidents
Musculoskeletal 290543 290543 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Exercise group will receive a three months whole body vibration treatment. Placebo group will receive a similar treatment without vibration. During the study, all participants will receive usual inpatient care of the nursing home. Whole body vibration will be applied during one hour per week distributed between different days and consist of six static exercises with rest between exercises targeting lower limb muscles. Participants will stand on the whole body vibration or placebo platform in a semi-squat position and hold on to the railings secured onto the platform. The frequency (load) of the vibrating platform will be at 12.5 to 18.5 Hz and the amplitude will be 4 mm. The intervention will begin with two 30 seconds sets of three exercices with 30 seconds rest between exercises. The exercise volume and intensity will be progressively increased according to the overload-principle.
Intervention code [1] 287981 0
Prevention
Intervention code [2] 287982 0
Rehabilitation
Intervention code [3] 287983 0
Treatment: Other
Comparator / control treatment
The control group will receive usual care of the nursing home and a placebo trainning. Placebo group will make the same exercises than vibration group in the placebo platform. This platform has the appearance of a conventional vibrating platform. It has a speaker hidden in the base and is connected to a computer, but it does not emit any kind of vibration.
Control group
Placebo

Outcomes
Primary outcome [1] 290529 0
- Fear of falling (Fes-I)
Timepoint [1] 290529 0
Baseline and three months later
Primary outcome [2] 290568 0
- Balance (Biodex Balance System)
Timepoint [2] 290568 0
Baseline and three months later
Primary outcome [3] 290569 0
- Sense to vibration (Vibratron II, The Vibratron II provides a non-invasive means of measuring the sensitivity to vibration of a patient's feet)
Timepoint [3] 290569 0
Baseline and three months later
Secondary outcome [1] 304735 0
- Weight (using a Seca 780 bascule)
Timepoint [1] 304735 0
Baseline and three months later
Secondary outcome [2] 304736 0
- Body mass Index (bioimpedance with Tanita BC-418 MA)
Timepoint [2] 304736 0
Baseline and three months later
Secondary outcome [3] 304737 0
- Physical Activity (IPAQ, CHAMPS)
Timepoint [3] 304737 0
Baseline and three months later
Secondary outcome [4] 304738 0
- Daily functioning (Barthel index)
Timepoint [4] 304738 0
Baseline and three months later
Secondary outcome [5] 304739 0
- Perceived exertion (Borg Scale)
Timepoint [5] 304739 0
In each training session
Secondary outcome [6] 304740 0
- Depression (GDS)
Timepoint [6] 304740 0
Baseline and three months later
Secondary outcome [7] 304741 0
- Vision (FVSQ)
Timepoint [7] 304741 0
Baseline
Secondary outcome [8] 304742 0
- Attitude to a fall prevention intervention (AFRIS)
Timepoint [8] 304742 0
Baseline
Secondary outcome [9] 304743 0
Fitness tests (Time Up & Go, Chair & Stand test, 6 minutes walking test, 10 meter test, Functional Reach, Sit & Reach, Four Square Step test, hand strength)
Timepoint [9] 304743 0
Baseline and three months later
Secondary outcome [10] 304807 0
- Leg strength (isokinetic dynamometer)
Timepoint [10] 304807 0
Baseline and three months later
Secondary outcome [11] 304808 0
- Health related quality of life (EQ-5D-5L, 15-D and SF-12)
Timepoint [11] 304808 0
Baseline and three months later

Eligibility
Key inclusion criteria
Individuals are potentially eligible if they meet all of the following criteria: (i) Aged 65 years or over; (ii) living in a nursing home; (iii) have fear of falling (FES-I score >23) ; (iv) can provide written informed consent to participate in the study; (v) can do all the physical fitness tests; (vi) have capacity to understand instructions.
Minimum age
65 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinicians may consider a patient unsuitable to enrol if they have any of the following: (i) History of severe trauma; (ii) Artificial prosthesis; (iii) Peripheral nerve entrapment; (iv) Inflammatory rheumatic diseases; (v) Severe cognitive impairment or otherwise judged unable to understand or comply with treatment protocol; (vi) Other diseases that do not allow them to make the training protocol; (vii) Having some other pathology that contraindicates exercise program or requiring special care (coronary artery disease, thrombosis, bone diseases, lung or kidney moderate or severe); (viii) Having some pathology that required daily intake of psychotropic drugs or affecting the vestibular system (Parkinson, etc..) to avoid the influence on measures of balance; (ix) Participation in regular physical exercise programs more than once a week for 30 minutes or more, during two weeks, in the last five years.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be recruited from a nursing home. Eligible patients will be screened for inclusion in the study. They will be informed about the study intervention and protocol. If they agree in participate then they will be visited by a research assistant and informed consent will be obtained. Following this, they will be randomised in an intervention or placebo group. Randomisation will be ascertained by a randomisation schedule held at a distant site. This schedule will be compiled by someone with no involvement in the study to maintain the blindage. In this sense, people who apply the training to patients are different from those who will perform the initial and final measurements. Researchers conducting measurements will not know to which group each participant pertain.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated using a through numeric list randomly generated within Microsoft Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 5424 0
Spain
State/province [1] 5424 0
CACERES

Funding & Sponsors
Funding source category [1] 287991 0
Government body
Name [1] 287991 0
Goverment of Extremadura
Ayudas para la formacion predoctoral de investigadores
Country [1] 287991 0
Spain
Primary sponsor type
University
Name
University of Extremadura
Address
Faculty of Sport Sciences
Avenida de la Universidad, sin numero.
10071, Caceres
Country
Spain
Secondary sponsor category [1] 286709 0
None
Name [1] 286709 0
Address [1] 286709 0
Country [1] 286709 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289917 0
Biosecurity and Bioethics Committee of the University of Extremadura
Ethics committee address [1] 289917 0
Ethics committee country [1] 289917 0
Spain
Date submitted for ethics approval [1] 289917 0
Approval date [1] 289917 0
30/01/2013
Ethics approval number [1] 289917 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43082 0
Prof Narcis Gusi Fuertes
Address 43082 0
Exercise, Quality of Life & Health Economics
Faculty of Sport Sciences
Universidad de Extremadura
10071 Caceres (Spain)
Country 43082 0
Spain
Phone 43082 0
+34 927 257460
Fax 43082 0
+34 927 257461
Email 43082 0
[email protected]
Contact person for public queries
Name 43083 0
Narcis Gusi Fuertes
Address 43083 0
Exercise, Quality of Life & Health Economics
Faculty of Sport Sciences
Universidad de Extremadura
10071 Caceres (Spain)
Country 43083 0
Spain
Phone 43083 0
+34 927 257460
Fax 43083 0
+34 927 257461
Email 43083 0
[email protected]
Contact person for scientific queries
Name 43084 0
Narcis Gusi Fuertes
Address 43084 0
Exercise, Quality of Life & Health Economics
Faculty of Sport Sciences
Universidad de Extremadura
10071 Caceres (Spain)
Country 43084 0
Spain
Phone 43084 0
+34 927 257460
Fax 43084 0
+34 927 257461
Email 43084 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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