UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000032703 |
|---|---|
| Receipt number | 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 | 2019/11/27 12:55:15 |
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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
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
mail@skjrc.jp
Sponsor or person
Institute
Shonan Kamakura Joint Reconstruction Center
Rehabilitation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037286
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