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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000047746
Receipt No. R000054429
Scientific Title Phase angle is related to physical function and quality of life in preoperative patients with lumbar spinal stenosis
Date of disclosure of the study information 2022/05/13
Last modified on 2022/05/13

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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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