UMIN-CTR Clinical Trial

Basic information
Public title	Morteza Barzegar Befrouei
Acronym	Morteza Barzegar
Scientific Title	The effect of fatigue on the lower extremity joint angle(knee and ankle) and pain in the soles of the feet climbers before and after mountaineering
Scientific Title:Acronym	The effect of fatigue on the lower extremity joint angle(knee and ankle) and pain in the soles of the feet climbers before and after mountaineering
Region	Asia(except Japan)

Condition
Condition	in progress
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is hypothesized that changes in the skeletal structure of the foot may lead to changes in walking patterns and excessive loading on the bone and soft tissue structures, causing pain and injury to these areas.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	no outcome
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	Diagnosis
Type of intervention	Other
Interventions/Control_1	climbing programe
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	20 years-old <=
Age-upper limit	35 years-old >=
Gender	Male and Female
Key inclusion criteria	at least one-year mountain climbing
Key exclusion criteria	injury
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Amir Hossein Middle name Last name Barati
Organization	Department of Sports Health and Rehabilitation, Faculty of Sports Sciences and Health, Shahid Beheshti University,
Division name	Department of Physical Education and Sport Sciences, School of Physical Education and Sport Sciences
Zip code	1983969411
Address	Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran, Iran
TEL	00982129902265
Email	ah_barati@sbu.ac.ir

Public contact
Name of contact person	1st name Morteza Middle name Last name Barzegar
Organization	Department of Sports Health and Rehabilitation, Faculty of Sports Sciences and Health, Shahid Behesh
Division name	Physical Education and Sport Sciences Faculty, Biological Sciences Department,
Zip code	1983969411
Address	Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran, Iran
TEL	00982129902265
Homepage URL
Email	M.barzegar9489@gmail.com

Sponsor
Institute	Department of Sports Health and Rehabilitation, Faculty of Sports Sciences and Health, Shahid Beheshti University, Tehran, Iran
Institute
Department

Funding Source
Organization	Department of Sports Health and Rehabilitation, Faculty of Sports Sciences and Health, Shahid Beheshti University, Tehran, Iran
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, Shahid Shahriari Square, Evin, Tehran, Iran
Tel	00982129902265
Email	M.barzegar9489@gmail.com

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 09 Month 30 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	45
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	No longer recruiting
Date of protocol fixation	2021 Year 12 Month 01 Day
Date of IRB	2021 Year 12 Month 30 Day
Anticipated trial start date	2022 Year 05 Month 20 Day
Last follow-up date	2022 Year 06 Month 20 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 03 Month 22 Day
Last modified on	2022 Year 03 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053893