UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009694 |
|---|---|
| Receipt number | R000011363 |
| Scientific Title | Effects of a 12-week whole body vibration training in Type 2 Diabetes in a primary healthcare setting. A Randomized Controlled Trial |
| Date of disclosure of the study information | 2013/01/05 |
| Last modified on | 2013/01/04 20:17:04 |
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Basic information
Public title
Effects of a 12-week whole body vibration training in Type 2 Diabetes in a primary healthcare setting. A Randomized Controlled Trial
Acronym
Whole body vibration training in Type 2 Diabetes
Scientific Title
Effects of a 12-week whole body vibration training in Type 2 Diabetes in a primary healthcare setting. A Randomized Controlled Trial
Scientific Title:Acronym
Whole body vibration training in Type 2 Diabetes
Region
| Europe |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the feasibility, safety and effectiveness of a 12-wk WBV intervention on glycemic control, lipid-related cardiovascular risk factors, quality of life, blood flow, balance and functional capacity among T2DM patients in a primary care context
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Glycated hemoglobin -HbA1c-,
Key secondary outcomes
Quality of life, Blood flow, balance, 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- test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Whole body vibration group (WBV) which will perform a 12-week WBV-based program on an oscillating platform (12-16 Hz; 4 mm; 3 sessions a week) or usual-care control group (CON).
Interventions/Control_2
Whole body vibration group (WBV) which will perform a 12-week WBV-based program on an oscillating platform (12-16 Hz; 4 mm; 3 sessions a week) or usual-care control group (CON).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible participants had to have T2DM confirmed by a primary care provider and based on the ADA diagnostic criteria
Key exclusion criteria
Exclusion criteria include 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 will be omitted. Moreover, participants receiving physical therapy will be excluded to avoid possible interactions with the present trial
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Borja Sañudo |
Organization
University of Seville
Division name
Department of Physical Education and Sport
Zip code
Address
Pirotecnia s/n
TEL
+81-034652387090
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Borja Sañudo |
Organization
University of Seville
Division name
Department of Physical Education and Sport
Zip code
Address
Pirotecnia s/n
TEL
+81-034652387090
Homepage URL
bsancor@us.es
Sponsor or person
Institute
University of Seville
Institute
Department
Personal name
Funding Source
Organization
University of Seville
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
University of Seville(Spain)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2011 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 04 | Day |
Last modified on
| 2013 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011363
