UMIN-CTR Clinical Trial

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
Email	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
Email	m.sarabzadeh89@mailfa.com

Sponsor
Institute	Department of Physiotherapy, AJA University of Medical Sciences, Tehran, IR
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053509