UMIN-CTR Clinical Trial

Basic information
Public title	The Effect of Postoperative Grip Strength on Frailty, Falls, and Mortality in Hip Fracture Patients One Year Later
Acronym	The Effect of Postoperative Grip Strength on Frailty, Falls, and Mortality in Hip Fracture Patients One Year Later
Scientific Title	The Effect of Postoperative Grip Strength on Frailty, Falls, and Mortality in Hip Fracture Patients One Year Later
Scientific Title:Acronym	The Effect of Postoperative Grip Strength on Frailty, Falls, and Mortality in Hip Fracture Patients One Year Later
Region	Japan

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

Objectives
Narrative objectives1	We aim to investigate postoperative grip strength and 1-year postoperative outcomes to test the hypothesis that postoperative grip strength influences frailty, falls and mortality.
Basic objectives2	Others
Basic objectives -Others	cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical Frailty index, falls, mortality, and days until death at 1 year postoperatively
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Able to measure grip strength
Key exclusion criteria	Unable to obtain consent for research Died during hospitalization and was discharged
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yota Middle name Last name Yamazaki
Organization	Shizuoka City Shimizu Hospital
Division name	Department of Rehabilitation Technology
Zip code	4240055
Address	+81543361111
TEL	+81543361111
Email	18mr08@g.seirei.ac.jp

Public contact
Name of contact person	1st name Yota Middle name Last name Yamazaki
Organization	Shizuoka City Shimizu Hospital
Division name	Department of Rehabilitation Technology
Zip code	4240055
Address	1231 Miyakami, Shimizu-Ku, Shizuoka, Shizuoka, Japan
TEL	+81543361111
Homepage URL
Email	18mr08@g.seirei.ac.jp

Sponsor
Institute	Shizuoka City Shimizu Hospital
Institute
Department

Funding Source
Organization	Shizuoka City Shimizu 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	Shizuoka City Shimizu Hospital Research Ethics Committee
Address	1231 Miyakami, Shimizu-Ku, Shizuoka, Shizuoka, Japan
Tel	+81543361111
Email	smz-hsp-soumu@city.shizuoka.lg.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	2022 Year 04 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	Open public recruiting
Date of protocol fixation	2020 Year 06 Month 19 Day
Date of IRB	2020 Year 06 Month 19 Day
Anticipated trial start date	2020 Year 06 Month 19 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We will review progress on a yearly basis and make any necessary revisions.

Management information
Registered date	2021 Year 10 Month 07 Day
Last modified on	2021 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052145