UMIN-CTR Clinical Trial

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
Email	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
Email	riha@syutaikai.com

Sponsor
Institute	Syutaikai hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051268