UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Improvement of functional activity and determinants of discharge delay in patients after Total knee arthroplasty
Title of the study (Brief title)	Improvement of functional activity and determinants of discharge delay in patients after Total knee arthroplasty
Region	Japan

Condition
Condition	Total knee arthroplasty
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of improvement of functional activity and determinants of discharge delay in patients after total knee arthroplasty surgery during inpatient rehabilitation.
Basic objectives2	Others
Basic objectives -Others	The purpose of improvement of pain and determinants of discharge delay in patients after total knee arthroplasty surgery during inpatient rehabilitation.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual Analog Scale
Key secondary outcomes	Maximum voluntary isometric knee extension force, Timed Up and Go test, 2 minites walk test,Pain Catastrophizing Scale

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	traditional exercise(40-60 minutes per day, 6 days a week, for 4 weeks)
Interventions/Control_2	traditional exercise(40-60 minutes per day, 6 days a week, for 4 weeks)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	underwent a primary unilateral Total knee arthroplasty.
Key exclusion criteria	bone and joint desease, neurological disorders with motor paralysis, dementia, inability to give informed consent form.
Target sample size	50

Research contact person
Name of lead principal investigator	Yoshida Yosuke
Organization	YamatoKashihara Hospital
Division name	Department of Rehabilitation Medicine
Address	81, Isikawa-cho, Kashihara-shi, Nara
TEL	0744-27-1071
Email	fortunatefield@yahoo.co.jp

Public contact
Name of contact person	Yoshida Yosuke
Organization	YamatoKashihara Hospital
Division name	Department of Rehabilitation Medicine
Address	81, Isikawa-cho, Kashihara-shi, Nara
TEL	0744-27-1071
Homepage URL
Email	fortunatefield@yahoo.co.jp

Sponsor
Institute	YamatoKashihara Hospital
Institute
Department

Funding Source
Organization	No outside funding was utilized in this trial.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 07 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 03 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 06 Day
Last modified on	2016 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025135