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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032703
Receipt No. R000037286
Scientific Title Effect of exercise differences on hip abductor muscle strength during the early stage after THA
Date of disclosure of the study information 2018/05/25
Last modified on 2018/05/24

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Basic information
Public title Effect of exercise differences on hip abductor muscle strength during the early stage after THA
Acronym Effect of exercise differences on hip abductor muscle strength during the early stage after THA
Scientific Title Effect of exercise differences on hip abductor muscle strength during the early stage after THA
Scientific Title:Acronym Effect of exercise differences on hip abductor muscle strength during the early stage after THA
Region
Japan

Condition
Condition Hip osteoarthritis
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of exercise differences on hip abductor muscle strength during early stage after THA,and to clarify effective exercises for improving abductor muscle strength as early as possible after THA.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Hip abductor muscle strength
Key secondary outcomes Patients demographics:
Age, sex, BMI, affected side, surgical procedure, comorbidities, history of disease, preoperative physical function

Postoperative physical function :
Hip Range of motion
Hip extensor muscle strength
Harris Hip Score
Timed 10-meter walk test

pain(gait)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Muscle strength exercise group
Interventions/Control_2 Stretch group
Interventions/Control_3 Muscle strength exercise and stretch group
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
30 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Primary THA
2)Patients scheduled THA on 3 on 5 days discharge critical path
3)Patients without severe internal medicine or orthopedic disease
4)Patients with hip joint ROM extension/internal rotation ・ internal or external rotation 0 or more before intervention
5)Patients scheduled THA in minimally invasive surgery
6)Patients without past osteotomy
7)Patients over 30 years old and under 80 years, patients without gender
8)Patients who have 3 weeks or more from preoperative evaluation to surgery
9)Patients that an agreement was provided
10)Patients who are effectively exercised at the time of evaluation at the 2 weeks before surgery
Key exclusion criteria 1)Patients who were operated on revision surgery
2)Patients with severe orthopedic disease
3)Patients with progressive disorder of the nervous system ond muscle
4)Patients scheduled for arthroplasy with osteotomy
5)Patients scheduled for arthroplasy with hip adductor muscle dehiscence
6)Patients with dementia
7)Patients with the depression or schizophrenic disorder
8)Patients with cerebro-vascular disease
9)Patients with untreated cardio-vascular disorder
10)Others who judged that a researcher was inappropriate
Target sample size 129

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

Sponsor
Institute Shonan Kamakura Joint Reconstruction Center

Rehabilitation
Institute
Department

Funding Source
Organization Shonan Kamakura Joint Reconstruction Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 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
2018 Year 05 Month 25 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 Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 15 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 24 Day
Last modified on
2018 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037286

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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