UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056428 |
|---|---|
| Receipt number | R000064183 |
| Scientific Title | Impact of Nutritional Intervention on Walking Recovery in Older People with Cognitive Impairment Undergoing Surgery for Proximal Femoral Fractures: A Quasi-Experimental Study |
| Date of disclosure of the study information | 2024/12/11 |
| Last modified on | 2025/12/12 08:25:58 |
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Basic information
Public title
Nutritional Support for Older People with Cognitive Impairment Who Have Had a Hip Fracture
Acronym
Nutritional Support Study for Older People with Cognitive Impairment
Scientific Title
Impact of Nutritional Intervention on Walking Recovery in Older People with Cognitive Impairment Undergoing Surgery for Proximal Femoral Fractures: A Quasi-Experimental Study
Scientific Title:Acronym
Cognitive Impairment Nutritional Intervention Study
Region
| Japan |
Condition
Condition
Proximal Femoral Fracture
Classification by specialty
| Orthopedics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to elucidate the impact of nutritional intervention on walking recovery in older people with cognitive impairment undergoing surgery for proximal femoral fractures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recovery of walking ability at the time of discharge from the orthopedic ward.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Nutrition supplements containing BCAA (branched-chain amino acids) will be provided once a day in addition to regular meals. The intervention period is planned from post-surgery until discharge from the orthopedic ward (approximately 8 weeks).
Interventions/Control_2
Standard care will be provided.
Only routine nutritional management offered by the hospital will be implemented.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients classified as having moderate malnutrition according to the GLIM criteria at the time of hospital admission.
2.Patients capable of oral intake.
3.Patients who were able to walk before the injury.
Key exclusion criteria
1.Patients undergoing dietary therapy with restricted energy or protein intake.
2.Patients with food allergies to milk or soy.
3.Patients undergoing treatment for malignant tumors.
4.Patients at high risk for refeeding syndrome.
5.Patients with obesity (BMI 35 and above).
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Funahashi |
Organization
Health Sciences University of Hokkaido
Division name
School of Nursing and Social Services
Zip code
061-0293
Address
1757 Kanazawa, Tobetsu-cho, Ishikari-gun, Hokkaido, Japan
TEL
0133-23-1537
kumi-funahashi@hoku-iryo-u.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Funahashi |
Organization
Health Sciences University of Hokkaido
Division name
School of Nursing and Social Services
Zip code
061-0293
Address
1757 Kanazawa, Tobetsu-cho, Ishikari-gun, Hokkaido, Japann
TEL
0133-23-1537
Homepage URL
kumi-funahashi@hoku-iryo-u.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Kumiko Funahashi
Funding Source
Organization
Japan Science and Technology Agency
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
Ethics Review Committee, School of Nursing and Social Services, Health Sciences University of Hokkaido
Address
1757 Kanazawa, Tobetsu-cho, Ishikari-gun, Hokkaido, Japan
Tel
0133-23-1211
nskyomu@hoku-iryo-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
| 2024 | Year | 12 | Month | 11 | 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
| 2024 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2026 | 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 | 11 | Day |
Last modified on
| 2025 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064183
