UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052508 |
|---|---|
| Receipt number | R000059919 |
| Scientific Title | Correlation between 6-Meter Walk Test, 4-Step Walking Distance, and 5-Time Chair Stand Test in Patients Undergoing Gastroenterological Surgery during the Perioperative Period: A Clinical Study |
| Date of disclosure of the study information | 2023/10/16 |
| Last modified on | 2024/10/19 15:06:53 |
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Basic information
Public title
Correlation between 6-Meter Walk Test, 4-Step Walking Distance, and 5-Time Chair Stand Test in Patients Undergoing Gastroenterological Surgery during the Perioperative Period: A Clinical Study
Acronym
Correlation between 6-Meter Walk Test, 4-Step Walking Distance, and 5-Time Chair Stand Test in Patients Undergoing Gastroenterological Surgery during the Perioperative Period: A Clinical Study
Scientific Title
Correlation between 6-Meter Walk Test, 4-Step Walking Distance, and 5-Time Chair Stand Test in Patients Undergoing Gastroenterological Surgery during the Perioperative Period: A Clinical Study
Scientific Title:Acronym
Correlation between 6-Meter Walk Test, 4-Step Walking Distance, and 5-Time Chair Stand Test in Patients Undergoing Gastroenterological Surgery during the Perioperative Period: A Clinical Study
Region
| Japan |
Condition
Condition
gastroenterological disease
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Due to the aging population, the number of patients with sarcopenia as a comorbidity is increasing. Furthermore, it has been reported that elderly individuals with sarcopenia have a higher risk of various postoperative complications, which can also affect their overall prognosis. Currently, the diagnosis criteria for sarcopenia by AWGS (Asian Working Group for Sarcopenia) assess physical function using measures such as 6-meter walk. However, these measurements can be somewhat cumbersome when taken on hospital wards. Therefore, we propose a more convenient indicator that can be used as an alternative to the 6-meter walk for assessing patients in hospital wards or outpatient settings.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between 6-Meter Walk Test, 4-Step Walking Distance, and 5-Time Chair Stand Test
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Measurement of 6-meter walking speed, 4-step walking distance, and the time taken for the 5-times chair stand test.
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 undergoing a gastroenterological surgery who can walk.
Key exclusion criteria
Exclude cases with intravenous poles, difficulty walking independently, or those deemed uncooperative.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Mikami |
Organization
St. Marianna University School of Medicine
Division name
Department of Gastroenterological and General Surgery
Zip code
2168511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki
TEL
0449778111
s2mikami@maarianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Sae |
| Middle name | |
| Last name | Kimura |
Organization
St. Marianna University School of Medicine
Division name
Department of Gastroenterological and General Surgery
Zip code
2168511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki
TEL
0449778111
Homepage URL
sae.kimura@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Shinya Mikami
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine IRB
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki
Tel
0449778111
sae.kimura@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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 16 | 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
50
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
| 2023 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059919
