UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051945 |
|---|---|
| Receipt number | R000059266 |
| Scientific Title | Effect of additional medical coverage to maintain or improve activities of daily living in an acute internal medicine ward. |
| Date of disclosure of the study information | 2023/08/20 |
| Last modified on | 2023/08/18 19:31:41 |
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Basic information
Public title
Effect of additional medical coverage to maintain or improve activities of daily living in an acute internal medicine ward.
Acronym
Effect of additional medical coverage to maintain or improve activities of daily living in an acute internal medicine ward.
Scientific Title
Effect of additional medical coverage to maintain or improve activities of daily living in an acute internal medicine ward.
Scientific Title:Acronym
Effect of additional medical coverage to maintain or improve activities of daily living in an acute internal medicine ward.
Region
| Japan |
Condition
Condition
Patients admitted to the gastroenterology ward
Classification by specialty
| Hepato-biliary-pancreatic medicine | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the effect of physical therapists' full-time work on patients admitted to the gastroenterology ward on falls and activities of daily living.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Barthel Index, Number of falls, Rehabilitation implementation rate, Length of hospital stay, Home discharge rate, New pressure ulcer rate.
Key secondary outcomes
Grip strength, Chair Stand Test-5, balance test (Number of seconds that can be maintained in standing with legs closed, half-legged, joined-legged, and single-legged), Finger ring test, 10m walking speed.
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 over 20 years old.
Patients admitted to the gastroenterology ward of Kurume University Hospital.
Key exclusion criteria
Patients who died during hospitalization or were transferred to another ward.
Patients who are judged to be inappropriate as subjects by the research director and co-investigators.
Target sample size
5110
Research contact person
Name of lead principal investigator
| 1st name | Shunji |
| Middle name | |
| Last name | Koya |
Organization
Kurume University Hospital
Division name
Division of Rehabilitation
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
TEL
0942317645
kouya_shunji@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunji |
| Middle name | |
| Last name | Koya |
Organization
Kurume University Hospital
Division name
Division of Rehabilitation
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
TEL
0942317645
Homepage URL
kouya_shunji@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
SHUNJI KOYA
Funding Source
Organization
Kurume University
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
Clinical Research Center, Kurume University Hospital
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
Tel
0942275210
kcrc_jimu@kurume-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 | 08 | Month | 20 | Day |
Related information
URL releasing protocol
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://kyusyu-society-pt.net/2022/file/2022_sho
Publication of results
Partially published
Result
URL related to results and publications
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://kyusyu-society-pt.net/2022/file/2022_sho
Number of participants that the trial has enrolled
242
Results
Full-time ward work of physical therapists improved physical function in patients with HCC, suggesting the usefulness of the maintenance and improvement system for ADL. Fall was a risk factor for worsening physical function. To prevent the worsening of physical function. The evaluation of falling risk by physical therapists may be important in hospitalized patients with HCC.
Results date posted
| 2023 | Year | 08 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We enrolled 242 patients with hepatocellular carcinoma who were admitted to the gastroenterology ward of Kurume University Hospital between January 22, 2019, and January 15, 2021, and who met the inclusion and exclusion criteria were enrolled. Inclusion criteria were 1) over 20 years of age, 2) patients admitted for treatment for HCC, and 3) patients who were able to assess LFI at admission. Exclusion criteria were: 1) patients hospitalized for non-therapeutic purposes for HCC (n=50); and 2) patients for whom LFI could not be evaluated at discharge (n=351).
Participant flow
A physical therapist worked full-time in the ward. Patients' activities of daily living were assessed by the Barthel Index, and physical function was assessed by grip strength, chair stand test-5, and balance test. Patients were treated to prevent falls and decline of physical functions as needed.
Adverse events
7 patients fell during hospitalization.
Outcome measures
Activities of daily living: Barthel Index
Physical function: Liver frailty index (grip strength, chair stand test-5, and balance test)
Performance Status
Standing test for Imbalance and Disequilibrium (SIDE)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Physical function is associated with poor prognosis in patients with carcinoma. This study investigates the effect of full-time ward work of physical therapists on physical function in addition to improvement in falls and declines in activities of daily living.
Management information
Registered date
| 2023 | Year | 08 | Month | 18 | Day |
Last modified on
| 2023 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059266
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/03/10 | Ver.4.0研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/03/10 | 研究症例データ仕様書.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/03/10 | 論文用 解析シート2 (2).xlsx |
