UMIN-CTR Clinical Trial

Basic information
Public title	Effect of instruction using measurement of physical activity on postoperative outcome in total joint replacement
Acronym	Effect of instruction using measurement of physical activity on postoperative outcome in total joint replacement
Scientific Title	Effect of instruction using measurement of physical activity on postoperative outcome in total joint replacement
Scientific Title:Acronym	Effect of instruction using measurement of physical activity on postoperative outcome in total joint replacement
Region	Japan

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

Objectives
Narrative objectives1	The patients with total joint replacement of lower limbs were required effective postoperative rehabilitation. In postoperative rehabilitation of total joint replacement, recovery of physical activity and physical performance were needed. To date, we performed exercise instruction based on medical interview. On the other hand, it was reported instruction using measurement of physical activity were more effective than only medical interview. Thus, the aim of this study is to investigate effect of instruction using measurement of physical activity on postoperative outcome in total joint replacement.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	gait speeds
Key secondary outcomes	muscle strength, pain, quality of life

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Instruction using measurement of physical activity
Interventions/Control_2	Instruction based on only medical interview
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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients underwent with total hip replacement or total knee replacement in our single hospital. Patients agreeed to join this research.
Key exclusion criteria	Patients were not ambulatory. Patients were diagnosed with cognitive impairment.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuhiro Hayashi
Organization	Nagoya Univversity Hospital
Division name	Department of Rehabilitation
Zip code
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-741-2111
Email	hayashi.k@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masato Kako
Organization	Nagoya Univversity Hospital
Division name	Department of Rehabilitation
Zip code
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-741-2111
Homepage URL
Email	kako-m@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya Univversity Hospital
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
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Other related organizations
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IRB Contact (For public release)
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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	名古屋大学医学部附属病院（愛知県）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 06 Month 03 Day
Date of IRB
Anticipated trial start date	2015 Year 06 Month 03 Day
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Other
Other related information

Management information
Registered date	2015 Year 06 Month 03 Day
Last modified on	2015 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020618

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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