UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048614 |
|---|---|
| Receipt number | R000055390 |
| Scientific Title | A pilot randomized controlled trial of the effect of home exercises on total hip arthroplasty patients. |
| Date of disclosure of the study information | 2022/08/08 |
| Last modified on | 2022/08/07 09:44:41 |
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Basic information
Public title
A comparative study of home exercise after total hip arthroplasty.
Acronym
A comparative study of the home exercise.
Scientific Title
A pilot randomized controlled trial of the effect of home exercises on total hip arthroplasty patients.
Scientific Title:Acronym
A comparison study of the home exercise after total hip arthroplasty.
Region
| Japan |
Condition
Condition
Osteoarthritis of hip
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Bilateral or single-leg standing-up exercise have been reported to improve lower extremity strength and motor function compared to existing programs, but there have been no reports in the elderly population or in patients underwent total hip arthroplasty. This study will examine the effects of a standing exercise regimen on hip function and gait speed compared to standard self-exercisers in patients with total hip arthroplasty.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Before exercise,postoperative 3 and 6 month in Harris Hip Score
Key secondary outcomes
Before exercise,postoperative 3 and 6 month in hip extension and abduction strength, 10m gait speed
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Standing-up exerecise group
Starting 1 month postoperatively, the patient is asked to standing-up exercise on bilateral or single legs and one leg 50 times a day from a pedestal 40 cm high for 6 months postoperatively.
Interventions/Control_2
Control group
Starting 1 month postoperatively, abduction and extension exercises of the surgical side hip joint using an exercise tube and body weight are performed 50 times a day for 6 months postoperatively.
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
| 65 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone unilateral hip replacement surgery at this hospital due to a diagnosis of osteoarthritis of the hip joint and who are within one month after the surgery at the time of registration.
Those who started outpatient rehabilitation within one month after the surgery at this hospital and who receive outpatient rehabilitation at least once a week.
65 years of age or older.
Key exclusion criteria
Previous surgery on a lower limb joint other than the hip.
Strong deformity of the spinal column and knee/ankle joints.
Neurological signs in the operated lower limb.
Severely limited range of motion in the hip and knee joints.
Patients with cognitive impairment
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shigeo |
| Middle name | |
| Last name | Fukunishi |
Organization
Nishinomiya Kaisei Hospital
Division name
Department orthopaedic surgery
Zip code
6620957
Address
1-4 Ohamacho, Nishinomiya City, Hyogo, Japan
TEL
0798-33-0601
fukunishi.shigeo@hmw.gr.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Kamiike |
Organization
Nishinomiya Kaisei Hospital
Division name
Department rehabilitation
Zip code
6620957
Address
1-4 Ohamacho, Nishinomiya City, Hyogo, Japan
TEL
0798-33-0601
Homepage URL
https://kaiseihp.jp/
kamiike.koichi@hmw.gr.jp
Sponsor or person
Institute
Nishinomiya Kaijo Hospital Hip Joint Self-Exercise Study Group
Institute
Department
Personal name
Funding Source
Organization
Nishinomiya Kaijo Hospital Hip Joint Self-Exercise Study Group
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
No
Address
No
Tel
No
No
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
西宮回生病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 07 | Day |
Last modified on
| 2022 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055390
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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| Registered date | File name |
