UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036561 |
|---|---|
| Receipt number | 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 | 2023/11/14 10:06:34 |
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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
International University of Health and Welfare
Division name
School of Health Science at Fukuoka
Zip code
831-8501
Address
137-1 Enokizu Okawa, fukuoka
TEL
0944892000
hiraga@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hiraga |
| Middle name | |
| Last name | Yuki |
Organization
International University of Health and Welfare
Division name
School of Health Science at Fukuoka
Zip code
831-8501
Address
137-1 Enokizu Okawa, fukuoka
TEL
0944892000
Homepage URL
hiraga@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
137-1 Enokizu Okawa, fukuoka
Tel
0944892000
hiraga@iuhw.ac.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
| 2025 | 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
| 2023 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041656
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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