UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063283 |
|---|---|
| Receipt number | R000072418 |
| Scientific Title | Association between preoperative nutritional status and recovery of basic movement ability in patients undergoing surgery for lumbar degenerative disease: a prospective longitudinal observational study using the ABMS II |
| Date of disclosure of the study information | 2026/10/14 |
| Last modified on | 2026/10/14 21:28:06 |
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Basic information
Public title
Study of preoperative nutritional status and postoperative recovery of basic movement ability in older patients undergoing surgery for lumbar degenerative disease
Acronym
Lumbar Nutrition and Functional Recovery Study
Scientific Title
Association between preoperative nutritional status and recovery of basic movement ability in patients undergoing surgery for lumbar degenerative disease: a prospective longitudinal observational study using the ABMS II
Scientific Title:Acronym
LNFR Study
Region
| Japan |
Condition
Condition
Lumbar degenerative disease
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between preoperative nutritional status and physical function, and the association between preoperative nutritional status and the recovery trajectory of basic movement ability from the early postoperative period to hospital discharge in patients aged 65 years or older undergoing surgery for lumbar degenerative disease.
Basic objectives2
Others
Basic objectives -Others
Investigation of the associations of preoperative nutritional status with physical function and postoperative recovery of basic movement ability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basic movement ability assessed using the Ability for Basic Movement Scale II (ABMS II).
ABMS II will be assessed preoperatively, on postoperative day 2-3, and at hospital discharge to investigate the association between preoperative nutritional status (GNRI and CONUT) and longitudinal changes in basic movement ability.
Key secondary outcomes
Preoperative physical function assessed using the Timed Up and Go test (TUG) and handgrip strength.
The associations of preoperative GNRI and CONUT with TUG and handgrip strength will be investigated.
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
| 65 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients scheduled to undergo surgery for lumbar degenerative disease.
2. Patients aged 65 years or older at the time of surgery.
Key exclusion criteria
1. Patients undergoing emergency surgery.
2. Patients who are unable to undergo the assessments required for this study due to cognitive impairment or other conditions.
3. Patients with neurological or musculoskeletal disorders other than lumbar degenerative disease that may substantially affect basic movement ability.
4. Patients receiving public assistance under the Public Assistance Act.
5. Patients considered unsuitable for participation in the study by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshitsugu |
| Middle name | |
| Last name | Fujii |
Organization
Japan Community Health Care Organization Tokuyama Central Hospital
Division name
Department of Rehabilitation
Zip code
7458522
Address
1-1 Koda-cho, Shunan, Yamaguchi 745-8522, Japan
TEL
0834284411
yo429rpt@gmail.com
Public contact
Name of contact person
| 1st name | Yoshitsugu |
| Middle name | |
| Last name | Fujii |
Organization
Japan Community Health Care Organization Tokuyama Central Hospit
Division name
Department of Rehabilitation
Zip code
7458522
Address
1-1 Koda-cho, Shunan, Yamaguchi 745-8522, Japan
TEL
0834284411
Homepage URL
yo429rpt@gmail.com
Sponsor or person
Institute
Japan Community Health Care Organization Tokuyama Central Hospit
Institute
Department
Personal name
Funding Source
Organization
Self-funded
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
Ethics Committee of Japan Community Health Care Organization Tokuyama Central Hospital
Address
1-1 Koda-cho, Shunan, Yamaguchi 745-8522, Japan
Tel
0834284411
irb-cr@tokuyama.jcho.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
K587-20261007
Org. issuing International ID_1
Ethics Committee of Japan Community Health Care Organization Tokuyama Central Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
JCHO徳山中央病院（山口県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2028 | Year | 10 | Month | 12 | Day |
Date of closure to data entry
| 2028 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2029 | Year | 10 | Month | 12 | Day |
Other
Other related information
There is no additional information to report.
Management information
Registered date
| 2026 | Year | 10 | Month | 14 | Day |
Last modified on
| 2026 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072418
