UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059763 |
|---|---|
| Receipt number | R000068340 |
| Scientific Title | A Feasibility Study of a Health Education Program in Postoperative Lumbar Rehabilitation |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/13 15:09:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Feasibility Study of a Health Education Program in Postoperative Lumbar Rehabilitation
Acronym
A Study on a Health Education Program after Lumbar Surgery
Scientific Title
A Feasibility Study of a Health Education Program in Postoperative Lumbar Rehabilitation
Scientific Title:Acronym
A Study on a Health Education Program after Lumbar Surgery
Region
| Japan |
Condition
Condition
Postoperative lumbar surgery patients
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of a health education program in postoperative lumbar rehabilitation.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Feasibility of the intervention program (recruitment, retention, and attendance)
Key secondary outcomes
Acceptability, satisfaction, and adherence of the intervention program
Health literacy (Functional, Communicative, and Critical Health Literacy: FCCHL)
Patient-reported outcomes (PROs) (Oswestry Disability Index 2.0: ODI, EuroQol-5D-5L: EQ-5D-5L)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Total 160 minutes (4 sessions of 40 minutes) during hospitalization. Program includes skills for information acquisition, disease-specific understanding, active action planning, and information sharing with others (health literacy education).
Interventions/Control_2
Control group: Usual care consisting of standard patient education (40 minutes).
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients admitted to Gakkentoshi Hospital for lumbar surgery and transferred to the rehabilitation unit
Age >= 40 years
Provided informed consent
Key exclusion criteria
Patients undergoing reoperation
Patients with severe comorbidities
Patients with cognitive impairment
Patients without electronic devices with search functions
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Issei |
| Middle name | |
| Last name | Higashino |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
536-8525
Address
2-1-132 Morinomiya, Joto-ku, Osaka-City, Osaka, Japan
TEL
06-6167-1250
h.i.y.g.48@gmail.com
Public contact
Name of contact person
| 1st name | Issei |
| Middle name | |
| Last name | Higashino |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
536-8525
Address
2-1-132 Morinomiya, Joto-ku, Osaka-City, Osaka, Japan
TEL
06-6167-1250
Homepage URL
h.i.y.g.48@gmail.com
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Issei Higashino
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gakkentoshi Hospital
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Institutional Review Board of the Graduate School of Rehabilitation Science, Osaka Metropolitan University
Address
2-1-132 Morinomiya, Joto-ku, Osaka-City, Osaka, Japan
Tel
06-6167-1250
gr-mrny-reha-rinri@omu.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
学研都市病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 01 | 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
| 2025 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2030 | 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
| 2025 | Year | 11 | Month | 13 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068340
