UMIN-CTR Clinical Trial

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
Email	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/
Email	kamiike.koichi@hmw.gr.jp

Sponsor
Institute	Nishinomiya Kaijo Hospital Hip Joint Self-Exercise Study Group
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055390