UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2018 Year 05 Month 14 Day
Date of IRB	2018 Year 05 Month 14 Day
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	2019 Year 11 Month 27 Day

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