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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036561
Receipt No. R000041656
Scientific Title Factor analysis of activity pacing for after total knee arthroplasty
Date of disclosure of the study information 2019/04/20
Last modified on 2019/04/20

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Basic information
Public title Effect of activities pacing "activity diary" on pain and psychological factors and activity levels for after total knee arthroplasty
Acronym Impact of activity pacing on pain and psychological factors and activity
Scientific Title Factor analysis of activity pacing for after total knee arthroplasty
Scientific Title:Acronym Factor analysis of activity pacing
Region
Japan

Condition
Condition total knee arthroplasty patients
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to evaluate pain and psychological factors in patients after total knee arthroplasty, including good group where activity was expanded gradually after introduction of Activity Diary and failure group where activity was not expanded It is to clarify the influence on the activity amount.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Physical activity
Key secondary outcomes Pain, psychological factors

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 At the start of the knee replacement patient, an activity diary was introduced, and the number of steps, pain (11 steps), and comments were recorded daily.
Interventions/Control_2
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
90 years-old >
Gender Male and Female
Key inclusion criteria Patients undergoing total knee arthroplasty at Fukuoka Rehabilitation Hospital.
Key exclusion criteria Those who can not reflect dementia or psychiatric disorders and questionnaires in their own will.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Hiraga
Middle name
Last name Yuki
Organization Fukuoka Rehabilitation Hospital
Division name Derartment of Rehabilitaion
Zip code 8198551
Address 770-7, Nokata, Fukuoka Nishi-ku
TEL 0928121555
Email nokopata_nokopata@yahoo.co.jp

Public contact
Name of contact person
1st name Hiraga
Middle name
Last name Yuki
Organization Fukuoka Rehabilitation Hospital
Division name Derartment of Rehabilitaion
Zip code 8198551
Address 770-7, Nokata, Fukuoka Nishi-ku
TEL 0928121555
Homepage URL
Email nokopata_nokopata@yahoo.co.jp

Sponsor
Institute Fukuoka Rehabilitation Hospital
Institute
Department

Funding Source
Organization Fukuoka Rehabilitation Hospital
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 Fukuoka Rehabilitation Hospital
Address 770-7, Nokata, Fukuoka Nishi-ku
Tel 0928121555
Email nokopata_nokopata@yahoo.co.jp

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
2019 Year 04 Month 20 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 Open public recruiting
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
2019 Year 04 Month 17 Day
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
2020 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 20 Day
Last modified on
2019 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041656

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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