UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056546 |
|---|---|
| Receipt number | R000064618 |
| Scientific Title | A Novel Non-Pharmacological Approach Combining Physical and Cognitive Interventions to Prevent Postoperative Delirium in Elderly Hip Surgery Patients |
| Date of disclosure of the study information | 2024/12/24 |
| Last modified on | 2026/01/14 19:41:31 |
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Basic information
Public title
A Novel Non-Pharmacological Approach Combining Physical and Cognitive Interventions to Prevent Postoperative Delirium
in Elderly Hip Surgery Patients
Acronym
A Novel Non-Pharmacological Approach Combining Physical and Cognitive Interventions to Prevent Postoperative Delirium
in Elderly Hip Surgery Patients
Scientific Title
A Novel Non-Pharmacological Approach Combining Physical and Cognitive Interventions to Prevent Postoperative Delirium
in Elderly Hip Surgery Patients
Scientific Title:Acronym
A Novel Non-Pharmacological Approach Combining Physical and Cognitive Interventions to Prevent Postoperative Delirium
in Elderly Hip Surgery Patients
Region
| Japan |
Condition
Condition
Hip osteoarthritis,Acetabular labral tear
Classification by specialty
| Orthopedics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of preoperative exercise and cognitive intervention as a new preventive care for postoperative delirium in elderly patients undergoing hip surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative delirium.
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
For 14 days before the surgery, subjects will use a pamphlet to perform six types of upper body exercises, and will complete 10 brain training questions per day using a question booklet (memory, recall, calculation, later recall, language, writing, graphic description, visual perception, etc.).
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elective surgery patients aged 65 years or older undergoing hip surgery under general anesthesia.
Key exclusion criteria
Patients with dementia, patients with delirium symptoms before surgery, and patients who are unable to perform exercise and cognitive training on their own.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yukari |
| Middle name | |
| Last name | Murakawa |
Organization
University of Kochi
Division name
Faculty of Nursing/Graduate School of Nursing
Zip code
781-8515
Address
2751-1 Ike, Kochi, Kochi
TEL
088-847-8706
murakawa_yukari@cc.u-kochi.ac.jp
Public contact
Name of contact person
| 1st name | Yukari |
| Middle name | |
| Last name | Murakawa |
Organization
University of Kochi
Division name
Faculty of Nursing/Graduate School of Nursing
Zip code
781-8515
Address
2751-1 Ike, Kochi, Kochi
TEL
088-847-8706
Homepage URL
murakawa_yukari@cc.u-kochi.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
n/a
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Kochi
Address
2751-1 Ike, Kochi, Kochi
Tel
088-847-8706
murakawa_yukari@cc.u-kochi.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
| 2024 | Year | 12 | Month | 24 | 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
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 03 | 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 | 12 | Month | 24 | Day |
Last modified on
| 2026 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064618
