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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018546
Receipt No. R000021451
Scientific Title The comparison study between the healthy persons in middle ages and elderly about lower extremity function and physical activity after total hip arthroplasty(THA) at 10-years.
Date of disclosure of the study information 2015/08/05
Last modified on 2016/06/28

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Basic information
Public title The comparison study between the healthy persons in middle ages and elderly about lower extremity function and physical activity after total hip arthroplasty(THA) at 10-years.
Acronym The comparison between healthy persons in middle ages and elderly about lower extremity function.
Scientific Title The comparison study between the healthy persons in middle ages and elderly about lower extremity function and physical activity after total hip arthroplasty(THA) at 10-years.
Scientific Title:Acronym The comparison between healthy persons in middle ages and elderly about lower extremity function.
Region
Japan

Condition
Condition Hip osteoarthritis
The healthy persons in middle ages and elderly
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to compare patients after THA at 10-years with the healthy persons in middle ages and eldery about lower extremity function and physical activity
And consider the necessity of continued intervention to patients after THA at 10-years
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Hip abductor muscle strength
Key secondary outcomes Physical activity
(International Physical Activity Questionnaire(IPAQ))
5-m timed gait test
One leg standing test
Lower limb circumferences
Timed up and Go (TUG) test

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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients after THA at 10-years
2)The healthy persons in middle ages and ellderly
Key exclusion criteria 1)Persons with past surgical history
2)Persons with progressive disorder of the nervous system and muscle
3)Persons scheduled for arthroplasy with osteotomy
4)Persons scheduled for arthroplasy with hip adductor muscle dehiscence
5)Persons with dementia
6)Persons with the depression or schizophrenic disorder
7)Persons with cerebro-vascular disease
8)Persons with untreated cardio-vascular disorder
Target sample size 111

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Hirakawa
Organization Shonan Kamakura Joint Reconstruction Center
Division name Department of Orthopaedic Surgery
Zip code
Address 5-4-17 Dai, Kamakura, Kanagawa, Japan
TEL 0467-47-2377
Email mail@skjrc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Suzuki
Organization Shonan Kamakura Joint Reconstruction Center
Division name Department of Rehabilitation
Zip code
Address 5-4-17 Dai, Kamakura, Kanagawa, Japan
TEL 0467-47-2377
Homepage URL
Email reha@skjrc.jp

Sponsor
Institute Shonan Kamakura Joint Reconstruction Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokushukai Kamakura Gymnastics Club
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 医療法人沖縄徳洲会 湘南鎌倉人工関節センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 05 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 Completed
Date of protocol fixation
2015 Year 07 Month 08 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information Influential factor: aging and THA.
Outcome : lower extremity function and physical activity.
Prospective stdy.

Management information
Registered date
2015 Year 08 Month 05 Day
Last modified on
2016 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021451

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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