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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042423
Receipt No. R000048430
Scientific Title Examination of the correlation between 6m walking speed and 3-step walking distance
Date of disclosure of the study information 2020/11/11
Last modified on 2020/11/11

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Basic information
Public title Examination of the correlation between 6m walking speed and 3-step walking distance
Acronym Examination of the correlation between walking speed and walking distance
Scientific Title Examination of the correlation between 6m walking speed and 3-step walking distance
Scientific Title:Acronym Examination of the correlation between walking speed and walking distance
Region
Japan

Condition
Condition sarcopenia
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The 6-meter gait speed measurement used in the current AWGS diagnostic criteria for sarcopenia is somewhat cumbersome as a screening method because it requires a linear space of more than 6 meters.
The establishment of a simple physical function assessment method equivalent to and simpler than the 6-meter gait speed measurement would make it a more versatile diagnostic criterion.
To establish an alternative evaluation method for 6 m walking speed measurement, we will examine the correlation with the distance traveled in the first 3 steps of walking in patients undergoing scheduled surgery in gastroenterology and general surgery, and examine the cutoff value of the 3 steps walking distance as a sarcopenia criterion.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between preoperative 6 m walking speed and 3 stepping distance
Key secondary outcomes Correlation between cutoff values of 3-step walking distance, 3-step walking distance and iliopsoas muscle index (PMI) at the third lumbar level in sarcopenia and non-sarcopenia groups on SMI and CT by impedance method.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are admitted to division of Gastroenterological and General Surgery of St. Marianna University School of Medicine Hospital.
The patient must be 20 years of age or older at the time of obtaining consent.
Patients who are fully informed and fully aware of their participation in the study and who have given their free written consent.
Key exclusion criteria Patients who have difficulty walking on their own (patients who require a cane and assistive devices or who are on an IV at the time of the study)
Other patients who are judged to be unsuitable as subjects by the physician responsible for the study
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Takehito
Middle name
Last name Otsubo
Organization St. Marianna University School of Medicine
Division name Gastroenterological and General Surgery
Zip code 2168511
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL 044-977-8111
Email otsubo@marianna-u.ac.jp

Public contact
Name of contact person
1st name Saori
Middle name
Last name Umezawa
Organization St. Marianna University School of Medicine
Division name Gastroenterological and General Surgery
Zip code 2168511
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL 044-977-8111
Homepage URL
Email saori.umezawa@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Rehabilitation medicine,St.Marianna University School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB,St.Marianna University school of Medicine
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
Tel 044-977-8111
Email surgery@marianna-u.ac.jp

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 聖マリアンナ医科大学病院

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 11 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 Preinitiation
Date of protocol fixation
2020 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2021 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study of single arm

Management information
Registered date
2020 Year 11 Month 11 Day
Last modified on
2020 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048430

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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