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Trial registered on ANZCTR


Registration number
ACTRN12613000021774
Ethics application status
Approved
Date submitted
3/01/2013
Date registered
8/01/2013
Date last updated
27/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Whole body vibration training in Type 2 Diabetes in a primary healthcare setting
Scientific title
Effects of a 12-week whole body vibration training in Type 2 Diabetes in a primary healthcare setting. A Randomized Controlled Trial
Secondary ID [1] 281729 0
None
Universal Trial Number (UTN)
U1111-1138-2097
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 288033 0
Balance disturbances 288034 0
Condition category
Condition code
Metabolic and Endocrine 288406 288406 0 0
Diabetes
Physical Medicine / Rehabilitation 288407 288407 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be involved in a 12-week WBV-based program on a side-alterning vibration platform (Phyisio Wave 700, Globus, Italy) comprising three sessions per week, one day between off sessions. All sessions will be conducted one-on-one with a physical therapist. Each exercise session was performed through the frequency of 12 Hz for the first month, 14 Hz for the second month and 16 Hz for the last month. Peak to peak displacement of 4 mm was maintained during the whole program. Participants must adopt an isometric squat position during all exposures, with knees flexed at 100 degrees during 30 s. After that, subjects will be asked to perform 8 exercises on the vibration platform (lunge, step up and down, squat, calf raises, left and right pivot, shoulder abduction with elastic bands, shoulder abduction with elastic bands while squatting, arm swinging with elastic bands) with slow movements at a rate of 2s for both concentric and eccentric phases. For the first month, the duration of exercises was 30s with a recovery time of 30 s between exercises. For the second and third month, duration of exercises will be increased up to 45s and 60s respectively with a maintained recovery time of 30s. Therefore a typical session will last approximately 20 min. To ensure a correct and safety increase in intensity through the program, each first day of intensity increase, a pre-exercise, post-exercise and post 48h fasting blood glucose control will be performed in each patient.
Intervention code [1] 286267 0
Rehabilitation
Comparator / control treatment
Usual-care control group (The usual care control group will receive medical treatment for diabetes and continue their normal daily activities during the period of the intervention, which did not include any structured exercise).
Control group
Active

Outcomes
Primary outcome [1] 288578 0
glycated hemoglobin -HbA1c- will be determined using Glyc-
Affin GHb kit (Isolab, Inc., Akron, OH )
Timepoint [1] 288578 0
before and after the 12-week intervention
Secondary outcome [1] 300494 0
fasting blood glucose (mg/dl)
Timepoint [1] 300494 0
Baseline and week 12
Secondary outcome [2] 300515 0
lipid-related cardiovascular risk factors (i.e. Cholesterol, Triglycerides, High Density Lipoprotein –HDL-and Low Density lipoprotein –LDL-).
Timepoint [2] 300515 0
Baseline and at week 12
Secondary outcome [3] 300516 0
Time Up and Go (TUG) test.
Timepoint [3] 300516 0
Baseline and week 12
Secondary outcome [4] 300517 0
Six Minutes Walking Test (T6MW).
Timepoint [4] 300517 0
Baseline and week 12
Secondary outcome [5] 300518 0
30-s Sit-to-Stand (30s-STS).
Timepoint [5] 300518 0
Baseline and week 12
Secondary outcome [6] 300519 0
Blood flow: maximum systolic velocity (VS), maximum diastolic velocity (VD), time averaged mean (TAM), heart rate (HR), pulsatility index (PI), which is the result of FS-FD/TAM, and resistance index (RI) which is the result of systolic frequency- diastolic frequency/ systolic frequency. For blood cell velocity measurements, intensity weighted mean velocity (Vmed), peak blood velocities (TPVM) and acceleration time to peak flow (Tacel). Outcomes will be recorded by a pulsed color-coded Doppler ultrasound Scanner (Philips EnVisor; Philips Medical, Andover, MA) with a 5–10 MHz broadband linear array transducer (Philips EnVisor C, L12-3, Andover, MA).
Timepoint [6] 300519 0
Baseline and week 12
Secondary outcome [7] 300520 0
Balance: measurement of center of pressure (COP) excursions in the anteroposterior (AP) and mediolateral (ML) directions by means of Wii Balance Board (WBB, Nintendo, Kyoto, Japan) connected wirelessly with a Bluetooth adapter to a laptop computer and raw data will be stored and processed using custom-written software (Labview 8.5 National Instruments, Austin, TX, U.S.A).
Timepoint [7] 300520 0
Baseline and week 12

Eligibility
Key inclusion criteria
Eligible participants had to have T2DM confirmed by a primary care provider and based on the ADA diagnostic criteria.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included history or evidence of advanced cardiovascular, renal or hepatic diseases, diabetic retinopathy, nephropathy, or neuropathy, insulin use, orthopedic or other limitations that may interfere with their ability to exercise safely. Participants with HbA1c >10% also were omitted. Moreover, participants receiving physical therapy were excluded to avoid possible interactions with the present trial.

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)
Participants will be randomly assigned by using a computer-generated random number sequence to either a WBV group (WBV) or usual-care control group (CON). Randomization will be undertaken by a member of the research team not directly involved in the recruitment or assessment of patients. The randomization sequence will be disclosed to the researcher responsible for the day-to-day running of the trial until patients had completed their baseline assessments.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The normality of the data will be evaluated by the Kolmogorov-Smirnov test. When non-parametric distribution, differences between groups at baseline will be tested using Mann–Whitney’s and kruskall Wallis test will be used to compare differences between groups after treatment. When parametric distribution, differences between groups at baseline were tested using t-test for independent measures and ANOVA (group x time) adjusted by age of participants was used to compare differences between groups after treatment. Chi-squared analysis will be used for categorical variables in any case. A Spearman Rho correlation will be used to find the relationship between changes in two variables. Values will be shown as mean +/- SE and statistical significance was set at P < 0.05. All statistical analyses will be performed with SPSS version 17.0 (SPSS Inc., Chicago, IL, USA).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
10/09/2012
Actual
24/09/2012
Date of last participant enrolment
Anticipated
7/01/2013
Actual
17/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4774 0
Spain
State/province [1] 4774 0
Seville

Funding & Sponsors
Funding source category [1] 286518 0
Self funded/Unfunded
Name [1] 286518 0
None
Country [1] 286518 0
Primary sponsor type
University
Name
University of Seville
Address
Facultad de Ciencias de la Educacion. Departamento de Educacion Fisica y Deporte. C/ Pirotecnia s/n. Sevilla. E-41013
Country
Spain
Secondary sponsor category [1] 285310 0
None
Name [1] 285310 0
Address [1] 285310 0
Country [1] 285310 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288591 0
University of Seville
Ethics committee address [1] 288591 0
Vicerrectorado de Investigacion. Universidad de Sevilla. Pabellon de Brasil. Paseo de las Delicias s/n. Sevilla. E-41013
Ethics committee country [1] 288591 0
Spain
Date submitted for ethics approval [1] 288591 0
Approval date [1] 288591 0
23/06/2012
Ethics approval number [1] 288591 0

Summary
Brief summary
The aim of the current study is to assess the feasibility, safety and effectiveness of a 12-wk WBV intervention on glycemic control, lipid-related cardiovascular risk factors, blood flow, body composition, balance and functional capacity among T2DM patients in a primary care context and to quantify the possible relationship between glycemic control and functional capacity, between blood flow and body composition, and between balance and physical performance among Type 2 diabetes mellitus (T2DM) participants receiving the new intervention.
Sixty participants will be randomly assigned to either a whole body vibration group (WBV) or usual-care control group (CON). In addition to demographic information and clinical details, body composition (waist and hip circumference –WHR-, weight, height, percentage of body fat and fat-free mass) and blood flow (femoral artery diameter, maximum systolic velocity –VS-, maximum diastolic velocity –VD-, time averaged mean –TAM-, heart rate –HR-, pulsatility index –PI- and resistance index –RI-, mean velocity –Vmed-, peak blood velocities –TPVM- and acceleration time to peak flow –Tacel-); glycated hemoglobin -HbA1c-, fasting blood glucose, lipid-related cardiovascular risk factors (i.e. cholesterol, triglycerides, HDL, LDL, LDL/HDL and atherogenic index) and functional capacity as measured by time up and go -TUG- test, 6-minute walking test-T6MW and 30s-sit to stand-30s-STS- and measurement of center of pressure (COP) excursions in the anteroposterior (AP) and mediolateral (ML) directions, will be assessed at baseline and after the 12-week intervention. These findings may have important implications for primary healthcare-based diabetes fall prevention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36834 0
Prof Borja Sanudo
Address 36834 0
Facultad de Ciencias de la Educacion. Universidad de Sevilla. Campus Pirotecnia. C/ Pirotecnia s/n. E-41013
Country 36834 0
Spain
Phone 36834 0
+34 652387090
Fax 36834 0
Email 36834 0
[email protected]
Contact person for public queries
Name 36835 0
Borja Sanudo
Address 36835 0
Facultad de Ciencias de la Educacion. Universidad de Sevilla. Campus Pirotecnia. C/ Pirotecnia s/n. E-41013
Country 36835 0
Spain
Phone 36835 0
+34 652387090
Fax 36835 0
Email 36835 0
[email protected]
Contact person for scientific queries
Name 36836 0
Borja Sanudo
Address 36836 0
Facultad de Ciencias de la Educacion. Universidad de Sevilla. Campus Pirotecnia. C/ Pirotecnia s/n. E-41013
Country 36836 0
Spain
Phone 36836 0
+34 652387090
Fax 36836 0
Email 36836 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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