UMIN-CTR Clinical Trial

Basic information
Public title	Verification of relationship between muscle strength and postoperative Activity of Daily Living and nutritional status in patients with hip fractures.
Acronym	Verification of relationship between muscle strength and postoperative Activity of Daily Living and nutritional status in patients with hip fractures.
Scientific Title	Verification of relationship between muscle strength and postoperative Activity of Daily Living and nutritional status in patients with hip fractures.
Scientific Title:Acronym	Verification of relationship between muscle strength and postoperative Activity of Daily Living and nutritional status in patients with hip fractures.
Region	Japan

Condition
Condition	Hip fractures
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Nutritional assessment using the Geriatric Nutrition Risk Index (GNRI) was conducted in patients with proximal femoral fracture to investigate the relationship between muscle strength and ADL of these patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Barthel Index at discharge
Key secondary outcomes

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients aged 65 years or older who were hospitalized in our hospital for proximal femoral fracture and underwent surgery and postoperative rehabilitation between June 1 and April 30, 2019, 2018
Key exclusion criteria	Cases of abasia and death due to serious complications before injury
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takako Middle name Last name Nagai
Organization	Nihon University
Division name	Orthopedic surgery
Zip code	101-8309
Address	101-8309 1-6, Kandasurugadai, Chiyoda-ku, Tokyo
TEL	0332931711
Email	ntnyf092@yahoo.co.jp

Public contact
Name of contact person	1st name Takako Middle name Last name Nagai
Organization	Nihon University Hospital
Division name	Orthopedic surgery
Zip code	101-8309
Address	1-6, Kandasurugadai, Chiyoda-ku, Tokyo
TEL	0332931711
Homepage URL
Email	ntnyf092@yahoo.co.jp

Sponsor
Institute	Nihon University Hospital
Institute
Department

Funding Source
Organization	Nihon University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	N

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nihon University Hospital
Address	1-6, Kandasurugadai, Chiyoda-ku, Tokyo
Tel	0332931711
Email	ntnyf092@yahoo.co.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	2019 Year 09 Month 29 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	40
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	Main results already published
Date of protocol fixation	2018 Year 06 Month 01 Day
Date of IRB	2019 Year 09 Month 12 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 09 Month 01 Day

Other

Other related information

About 60% of patients with hip fractures are malnourished, contributing to postoperative complications and increased mortality. Then, the relation between nutritional evaluation and Activity of Daily Living of the hip fracture patient was verified. It was shown that the patient with the nutritional state risk tended to be inferior in muscle force and Activity of Daily Living in comparison with the patient without the risk. The possibility of improving the functional prognosis was shown by carrying out the appropriate nutritional administration in parallel with exercise therapy, when there is a nutritional state risk.

Management information
Registered date	2019 Year 09 Month 29 Day
Last modified on	2019 Year 09 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043479