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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009694
Receipt No. 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

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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
Email

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
Email bsancor@us.es

Sponsor
Institute University of Seville
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011363

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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