UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044886 |
|---|---|
| Receipt number | R000051268 |
| Scientific Title | About the effect of nutritional intervention on activities of daily living for patients with proximal femur fracture in our convalescent rehabilitation ward |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2021/07/17 01:00:32 |
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Basic information
Public title
About the effect of nutritional intervention on activities of daily living for patients with proximal femur fracture in our convalescent rehabilitation ward
Acronym
About the effect of nutritional intervention on activities of daily living for patients with proximal femur fracture in our convalescent rehabilitation ward
Scientific Title
About the effect of nutritional intervention on activities of daily living for patients with proximal femur fracture in our convalescent rehabilitation ward
Scientific Title:Acronym
About the effect of nutritional intervention on activities of daily living for patients with proximal femur fracture in our convalescent rehabilitation ward
Region
| Japan |
Condition
Condition
Proximal femoral fractures
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between the effects of nutritional interventions by dietary supplements on elderly people with proximal femur fractures, changes in walking ability, and activities of daily living
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in walking ability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
Those who were hospitalized between July 2021 and July 2022 and were able to take dietary supplements
Frequency of dietary supplements: 1 bag (100g) daily
Interventions/Control_2
Those who were hospitalized between November 2022 and November 2023
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
Persons aged 65 and over who were admitted to our convalescent rehabilitation ward for a fracture of the proximal femur between July 2021 and November 2023.
Key exclusion criteria
1.Those who have difficulty undergoing the bioimpedance method due to medical equipment such as a cardiac pacemaker
2.Persons with a history of cerebrovascular accident
3.Persons with dietary restrictions due to renal dysfunction, etc.
4.Persons with hypoproteinemia (hypoalbuminemia)
5.Those who have a cognitive function evaluation (MMSE) score of 23 points or less
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Kato |
Organization
Syutaikai hospital
Division name
Comprehensive Rehabilitation Center
Zip code
510-0823
Address
8-1, Shirokita-cho, Yokkaichi-shi, Mie-ken
TEL
059-354-1771
riha@syutaikai.com
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Kato |
Organization
Syutaikai hospital
Division name
Comprehensive Rehabilitation Center
Zip code
510-0823
Address
8-1, Shirokita-cho, Yokkaichi-shi, Mie-ken
TEL
059-354-1771
Homepage URL
riha@syutaikai.com
Sponsor or person
Institute
Syutaikai hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Medical Corporation Association Syutaikai Ethics committee
Address
8-1, Shirokita-cho, Yokkaichi-shi, Mie-ken
Tel
059-354-1771
riha@syutaikai.com
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
| 2021 | Year | 08 | 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
| 2021 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 07 | Month | 17 | Day |
Last modified on
| 2021 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051268
