UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053835 |
|---|---|
| Receipt number | R000060938 |
| Scientific Title | Feasibility test of rehabilitation in patients with sarcopenia |
| Date of disclosure of the study information | 2024/03/12 |
| Last modified on | 2024/03/12 16:32:55 |
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Basic information
Public title
Feasibility test of rehabilitation in patients with sarcopenia
Acronym
Feasibility test of rehabilitation in patients with sarcopenia
Scientific Title
Feasibility test of rehabilitation in patients with sarcopenia
Scientific Title:Acronym
Feasibility test of rehabilitation in patients with sarcopenia
Region
| Japan |
Condition
Condition
sarcopenia, pancreatic diseases
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine "Is short-term preoperative muscle rehabilitation safe and effective for patients undergoing pancreatectomy, including non-sarcopenic patients?"
To clarify "Are perioperative abnormalities of glucose metabolism in patients undergoing pancreatectomy with sarcopenia different from those in non-sarcopenia patients?
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in grip strength before and after rehabilitation
Key secondary outcomes
Safety of rehabilitation, implementation rate, and efficacy of non-primary endpoints. Short-term postoperative outcomes. Postoperative glycemic control. Biomarkers. Insulin resistance.
Study subjects will include non-sarcopenic and sarcopenic patients. The subjects will be divided into two groups to compare the endpoints.
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
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
All patients consenting to the study, with or without sarcopenia, will undergo rehabilitation with uniform goals, and the feasibility, safety efficacy, and perioperative complications of the rehabilitation will be evaluated. From the start of surgery to the end of the postoperative stay in the intensive care unit , blood glucose control using the STG-55 and continuous blood glucose monitoring will be performed to measure insulin requirements, blood glucose fluctuations, average blood glucose levels, etc.
Rehabilitation begins approximately one week prior to surgery and continues until the time of discharge.
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
1) Patients undergoing pancreatectomy as a gastrointestinal surgical procedure
2) Performance Status (ECOG scale): 0 to 2
3) Age: 20 years or older (at the time of enrollment)
4) Patients expected to survive more than 3 months from the date of enrollment
5) Patients with major organ function (bone marrow, heart, lungs, kidneys, etc.) as determined by examination within 14 days prior to enrollment
6) Patients who are able to take oral intake
7) Patients whose written consent has been obtained from the patient
Key exclusion criteria
1) Patients with obvious infection or inflammation (e.g., fever over 38.0 degrees Celsius)
2) Patients with serious cardiac complications (requiring hospitalization) or a history of such complications
3) Patients with serious complications (requiring hospitalization) such as intestinal paralysis, intestinal obstruction, diabetes mellitus, renal failure, and non-compensated liver cirrhosis
4) Patients with a large amount of ascites (moderate or greater, exceeding the pelvic cavity and accumulating in front of the liver on CT) or pleural effusion
5) Pregnant or lactating women or women of childbearing potential
6) Patients with paralysis of the extremities or other conditions that make assessment of sarcopenia difficult
7) Other patients deemed inappropriate for this study by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Hanazaki |
Organization
Kochi Medical school hospital
Division name
Director of hospital
Zip code
7838505
Address
Kohasu, Oko-cho, Nankoku-shi, Kochi
TEL
088-880-2370
im31@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazune |
| Middle name | |
| Last name | Fujisawa |
Organization
Kochi Medical School
Division name
Department of surgery
Zip code
7838505
Address
Kohasu, Oko-cho, Nankoku-shi, Kochi
TEL
088-880-2370
Homepage URL
im31@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Kochi Medical School
Address
Kohasu, Oko-cho, Nankoku-shi, Kochi
Tel
088-880-2180
is21@kochi-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
高知大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 12 | 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
| 2023 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2024 | Year | 03 | Month | 12 | Day |
Last modified on
| 2024 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060938
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