UMIN-CTR Clinical Trial

Basic information
Public title	Pilates training improved functional balance of male patients with Multiple Sclerosis
Acronym	Pilates, balance and Multiple Sclerosis
Scientific Title	Twelve weeks of Pilates training improved functional balance of male patients with Multiple Sclerosis: Randomized controlled trial
Scientific Title:Acronym	Pilates, balance and Multiple Sclerosis
Region	Asia(except Japan)

Condition
Condition	Multiple Sclerosis
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of Pilates training on functional balance in male patients with Multiple Sclerosis
Basic objectives2	Others
Basic objectives -Others	Differences between experimental group and the control group
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Functional balance
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Pilates Training
Interventions/Control_2	Control: usual care by their medical doctor
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	25 years-old <=
Age-upper limit	40 years-old >=
Gender	Male
Key inclusion criteria	Age range 25-40 years, disability score index 3 to 5, no history of heart disease, epilepsy, metabolic diseases, psychological problem, and orthopedic diseases. They should be at least two months post the last disease exacerbates, not participating in any physical activity in the last two months.
Key exclusion criteria	Any neurological symptoms in the last three weeks before starting the project, failure on participating in the Pilates training (being absent more than three intermittent or 2 continual sessions)
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Mehdi Middle name Last name Gheitasi
Organization	Shahid Beheshti University
Division name	Faculty of Sport Science & Health
Zip code	19839 69411
Address	Faculty of Sport Science & Health, Shahid Beheshti University, Velenjak, Daneshjoo Blvd., Tehran, Iran
TEL	+989123547613
Email	m_gheitasi@sbu.ac.ir

Public contact
Name of contact person	1st name Mohammad Middle name Last name Bayattork
Organization	University of Hormozgan
Division name	Faculty of Humanities Science
Zip code	7916193145
Address	Faculty of Humanities Science, University of Hormozgan, Bandar Abbas, Iran
TEL	+989155521005
Homepage URL
Email	mohammadbayat82@gmail.com

Sponsor
Institute	Shahid Beheshti University
Institute
Department

Funding Source
Organization	Self funding
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	Shahid Beheshti University
Address	Shahid Beheshti University, Velenjak, Daneshjoo Blvd., Tehran, Iran
Tel	021 29901
Email	m_gheitasi@sbu.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	2019 Year 10 Month 29 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	30
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	2018 Year 10 Month 01 Day
Date of IRB	2018 Year 10 Month 01 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2019 Year 10 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 29 Day
Last modified on	2019 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043791