UMIN-CTR Clinical Trial

Basic information
Public title	Impact of sacopenia and activities of daily living in patients with hip fractures
Acronym	Impact of sacopenia and ADL in patients with hip fractures
Scientific Title	Impact of sacopenia and activities of daily living in patients with hip fractures
Scientific Title:Acronym	Impact of sacopenia and activities of ADL in patients with hip fractures
Region	Japan

Condition
Condition	femoral neck fracture
Classification by specialty	Orthopedics Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship between the actual condition of sarcopenia and ADL at discharge in patients with proximal femoral fracture.
Basic objectives2	Others
Basic objectives -Others	Sarcopenia accounts for approximately 20 ~ 50% of proximal femoral fractures and is associated with a high risk of QOL deterioration and frailty. Therefore, rehabilitation requires not only measures against functional impairment but also measures against sarcopenia. However, the status of sarcopenia in the perioperative period and the relationship between sarcopenia and rehabilitation outcome are unclear. In this study, we investigated the actual condition of sarcopenia and factors affecting ADL in patients with proximal femoral fracture.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Barthel index efficacy
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 undergoing surgery and postoperative rehabilitation at our hospital for proximal femoral fracture
Key exclusion criteria	Patients with serious complications who were unable to walk or died before the injury
Target sample size	42

Research contact person
Name of lead principal investigator	1st name Takako Middle name Last name Nagai
Organization	Nihon university hospital
Division name	Orthpedic surgery
Zip code	101-8309
Address	1-6, kanda surugadai, Chiyoda-ku,Tokyo
TEL	03-3293-1711
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	Orthpedic surgery
Zip code	101-8309
Address	1-6, kanda surugadai, Chiyoda-ku,Tokyo
TEL	03-3293-1711
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

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

IRB Contact (For public release)
Organization	Nihon University hospital
Address	1-6, kanda surugadai, Chiyoda-ku,Tokyo
Tel	03-3293-1711
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	2020 Year 03 Month 20 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	42
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 12 Month 12 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

There were 28 patients in the sarcopenia group and 14 patients in the non-sarcopenia group. Univariate analysis revealed significant differences in age, body weight, body mass index (BMI), and dementia. In the correlation between BI gain and each value in Spearman's rank correlation coefficient, GNRI and BI at discharge showed positive correlation, and negative correlation in age, sarcopenia, CCI, PIMs, and cognitive function. Multiple regression analysis using BI at discharge as the dependent variable revealed that age and PIMs were significant associated factors.

Management information
Registered date	2020 Year 03 Month 20 Day
Last modified on	2020 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045491