UMIN-CTR Clinical Trial

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

sarcopenia

Classification by specialty

Surgery in general

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Department of Rehabilitation medicine,St.Marianna University School of Medicine

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

聖マリアンナ医科大学病院

Date of disclosure of the study information

2020

Year

11

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

observational study of single arm

Registered date

2020

Year

11

Month

11

Day

Last modified on

2020

Year

11

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048430