Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000189729
Ethics application status
Approved
Date submitted
12/02/2013
Date registered
18/02/2013
Date last updated
11/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Cost-utility and cost-effectiveness of a 8-wk whole-body vibration (WBV)-based intervention to improve balance and mobility among older adults with reduced mobility: a randomized controlled trial
Scientific title
Cost-utility and cost-effectiveness of a 8-wk WBV-based intervention to improve balance and mobility among older adults with reduced mobility: a randomized controlled trial
Secondary ID [1] 281944 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reduced mobility 288357 0
Condition category
Condition code
Physical Medicine / Rehabilitation 288707 288707 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will have access to the usual care and will be asked not to change their nutritional or exercise habits during the 8-wk period. Participants in the intervention group will participate in a 8-week whole body vibration (WBV)-based program on an vertical platform consisting of three sessions per week with at least one day between sessions. Each exercise session will have a duration of 10 to 15 minutes with a frequency (load) of the vibrating platform of 20Hz initially and progressing throughout the program up to 35 Hz and the amplitude will be of 4 mm in all sessions. Participants will stand on the platform in a semi-squat position in all exercises.
Intervention code [1] 286507 0
Rehabilitation
Comparator / control treatment
Control group will have access to the usual care from the nursing home
Control group
Active

Outcomes
Primary outcome [1] 288851 0
Balance assessed thorugh a force platform
Timepoint [1] 288851 0
8-wk
Primary outcome [2] 288876 0
Mobility assessed by the time up and go
Timepoint [2] 288876 0
8-wk
Secondary outcome [1] 301148 0
Quality of life (EQ-5D)
Timepoint [1] 301148 0
8-wk
Secondary outcome [2] 301220 0
isometric quadriceps strength assessed using a dynamometer
Timepoint [2] 301220 0
8-wk
Secondary outcome [3] 301221 0
Body composition (Percentage of body fat, weight and BMI) assessed by biompedance
Timepoint [3] 301221 0
8-wk

Eligibility
Key inclusion criteria
The inclusion criteria will be: Living in a nurse home and a level of exercise less than a150 min/week of moderate-intensity aerobic physical activity
Minimum age
65 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Potential participants were excluded if they had a baseline value for fasting blood glucose > 250 mg/dl or HbA1c > 10%, diagnosed cardiovascular or mental disease, a diabetes-related complication including nephropathy, or retinopathy unrepaired hernia, or any other functional impairment that would preclude safe participation in a WBV-based training program

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4860 0
Spain
State/province [1] 4860 0
Seville

Funding & Sponsors
Funding source category [1] 286723 0
University
Name [1] 286723 0
University of Seville
Country [1] 286723 0
Spain
Primary sponsor type
University
Name
University of Seville
Address
C/ Pirotecnia s/n

41012

Seville, Spain
Country
Spain
Secondary sponsor category [1] 285498 0
None
Name [1] 285498 0
Address [1] 285498 0
Country [1] 285498 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288795 0
University of Seville
Ethics committee address [1] 288795 0
Vicerrectorado de Investigacion. Universidad de Sevilla. Pabellon de Brasil. Paseo de las Delicias s/n. Sevilla
Postal Code: 41013
Ethics committee country [1] 288795 0
Spain
Date submitted for ethics approval [1] 288795 0
Approval date [1] 288795 0
Ethics approval number [1] 288795 0

Summary
Brief summary
Objective: To test the feasibility, safety and effectiveness of a 8-wk whole body vibration (WBV) intervention on balance and mobility among older adults with reduced mobility in a nursing home context.
Methods: Fifty older adults will be randomized 1:1 to an intervention group that, in addition to standard care, received a 8-wk WBV intervention, and a control group receiving only standard care . Outcomes, including balance, mobility and strenght or quality of life will be assessed after intervention
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37814 0
Dr Borja del Pozo-Cruz
Address 37814 0
Department of Physical Education and Sport. Univeristy of Seville
C/ Pirotecnia s/n
41012 Seville, Spain
Country 37814 0
Spain
Phone 37814 0
+34657627640
Fax 37814 0
Email 37814 0
bpozo@us.es
Contact person for public queries
Name 37815 0
Dr Borja
Address 37815 0
Department of Physical Education and Sport. Univeristy of Seville
C/ Pirotecnia s/n
41012 Seville, Spain
Country 37815 0
Spain
Phone 37815 0
+34657627640
Fax 37815 0
Email 37815 0
bpozo@us.es
Contact person for scientific queries
Name 37816 0
Dr Borja
Address 37816 0
Department of Physical Education and Sport. Univeristy of Seville
C/ Pirotecnia s/n
41012 Seville, Spain
Country 37816 0
Spain
Phone 37816 0
+34657627640
Fax 37816 0
Email 37816 0
bpozo@us.es

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

Documents added manually
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Documents added automatically
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