UMIN-CTR Clinical Trial

Basic information
Public title	Phase angle is related to physical function and quality of life in preoperative patients with lumbar spinal stenosis
Acronym	Phase angle is related to physical function and quality of life in preoperative patients with lumbar spinal stenosis
Scientific Title	Phase angle is related to physical function and quality of life in preoperative patients with lumbar spinal stenosis
Scientific Title:Acronym	Phase angle is related to physical function and quality of life in preoperative patients with lumbar spinal stenosis
Region	Japan

Condition
Condition	lumbar spinal stenosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship between Phase angle and physical function and quality of life in patients with lumbar spinal canal stenosis.
Basic objectives2	Others
Basic objectives -Others	Investigate physical function and quality of life.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Phase angle(Preoperative measurements)
Key secondary outcomes	handgrip strength, walking speed, timed up and go test, Life Space Assessment, Prognostic Nutritional Index, Japanese Orthopaedic Association back pain evaluation questionnaire, EQ-5D

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients over 20 years of age who were admitted to the Department of Orthopedic Surgery of Kurume University Hospital for surgery for a diagnosis of lumbar spinal canal stenosis between May 2020 and February 2022 are eligible for the study.
Key exclusion criteria	Patients with a history of pyogenic spondylitis, metastatic bone tumor, or stroke. Patients who have difficulty standing up due to hemiplegia, etc. and have difficulty in body composition measurement. Patients with a pacemaker inserted.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Ryota Middle name Last name Otsubo
Organization	Kurume University Hospital
Division name	Rehabilitation Department
Zip code	830-0011
Address	67 Asahi town, Kurume city, Fukuoka
TEL	0942353311
Email	ohtsubo_ryouta@kurume-u.ac.jp

Public contact
Name of contact person	1st name Ryota Middle name Last name Ohtsubo
Organization	Kurume University Hospital
Division name	Rehabilitation Department
Zip code	830-0011
Address	67 Asahi town, Kurume city, Fukuoka
TEL	0942353311
Homepage URL
Email	ohtsubo_ryouta@kurume-u.ac.jp

Sponsor
Institute	Kurume University Hospital Rehabilitation Department
Institute
Department

Funding Source
Organization	Department of Orthopaedic Surgery, Kurume University
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	Kurume University Medical Ethics Committee
Address	67 Asahi town, Kurume city, Fukuoka
Tel	0942317917
Email	i_rinri@kurume-u.ac.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 05 Month 13 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	250
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	No longer recruiting
Date of protocol fixation	2021 Year 05 Month 01 Day
Date of IRB	2022 Year 05 Month 09 Day
Anticipated trial start date	2021 Year 05 Month 01 Day
Last follow-up date	2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a retrospective, observational study, and the study will be conducted on cases from May 2020 to February 2022.

Management information
Registered date	2022 Year 05 Month 13 Day
Last modified on	2022 Year 05 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054429

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name
2022/05/13	分析用 データシート.xlsx

Research case data
Registered date	File name
2022/05/13	分析用 データシート.xlsx

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