UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046896 |
|---|---|
| Receipt number | R000053509 |
| Scientific Title | Whole-body vibration training improves balance parameters in obese elderly women: A cross-sectional analysis |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2022/02/14 01:22:53 |
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Basic information
Public title
Whole-body vibration training improves balance parameters in obese elderly women: A cross-sectional analysis
Acronym
Whole-body vibration training improves balance parameters in obese elderly women: A cross-sectional analysis
Scientific Title
Whole-body vibration training improves balance parameters in obese elderly women: A cross-sectional analysis
Scientific Title:Acronym
Whole-body vibration training improves balance parameters in obese elderly women: A cross-sectional analysis
Region
| Asia(except Japan) |
Condition
Condition
Obese elderly females
Classification by specialty
| Medicine in general | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of vibration training on balance parameters in obese women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
static and dynamic balance parameters evaluated by Zebris FDM system and FES-I assessment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
CWBV training three times weekly for six weeks under the supervision of an experienced physiotherapist and exercise physiologist.
Interventions/Control_2
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
Our inclusion criteria were (1) having normal vision, hearing and dexterity; (2) lack of personal background of any cancer, diabetes, and mental and neurological disorders or other significant diseases that either may bias the results or would be contraindications for vibration exercise; (3) having not been taken medications that could have affected balance and smooth movements in the last six months; (4) having minimum elementary education; and (7) having physical and cognitive ability confirmed through documentation on their medical records, and interest in participating in the intervention program.
Key exclusion criteria
The participants who did not comply with these criteria was excluded from the study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Manijeh |
| Middle name | |
| Last name | Soleimanifar |
Organization
healthy lifestyle Research group, Academic center of culture, education and research, Tehran, Iran
Division name
(ACECR)
Zip code
00982122306481
Address
(ACECR) Royan Institute, IR
TEL
00982123562000
Manijeh.soleimanifar@yahoo.com
Public contact
Name of contact person
| 1st name | Mostafa |
| Middle name | |
| Last name | Sarabzadeh |
Organization
National Elites Foundation, Tehran, Iran
Division name
Exercise Physiology and NeuroPhysiotherapy
Zip code
098
Address
No. 209, between Navab and Roudaki St., Azadi street, Tehran
TEL
0989376293463
Homepage URL
m.sarabzadeh89@mailfa.com
Sponsor or person
Institute
Department of Physiotherapy, AJA University of Medical Sciences, Tehran, IR
Institute
Department
Personal name
Funding Source
Organization
Department of Physiotherapy, AJA University of Medical Sciences, Tehran, IR
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Physiotherapy, Science and Research branch, Aja university of Medical Sciences, Tehran, Iran.
Address
Aja University of medical science, Kargar shomali, Sakhaei st
Tel
09821-86096350-5
m.soleimanifar@ajaums.ac.ir
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 01 | 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
15
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
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 14 | Day |
Last modified on
| 2022 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053509
