UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026843 |
|---|---|
| Receipt number | R000030808 |
| Scientific Title | Quantitative Assessment of Postoperative Physical Activities by Using Triaxial Accelerometry and RR-interval Monitoring |
| Date of disclosure of the study information | 2017/04/03 |
| Last modified on | 2021/04/07 12:37:57 |
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Basic information
Public title
Quantitative Assessment of Postoperative Physical Activities by Using Triaxial Accelerometry and RR-interval Monitoring
Acronym
Quantitative Assessment of Postoperative Physical Activities by Using Triaxial Accelerometry and RR-interval Monitoring
Scientific Title
Quantitative Assessment of Postoperative Physical Activities by Using Triaxial Accelerometry and RR-interval Monitoring
Scientific Title:Acronym
Quantitative Assessment of Postoperative Physical Activities by Using Triaxial Accelerometry and RR-interval Monitoring
Region
| Japan |
Condition
Condition
thoracic surgery
Classification by specialty
| Surgery in general | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this clinical research is to develop a method to evaluate postoperative physical activities quantitatively by using triaxial accelerometry and RR-interval monitoring.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
triaxial accelerometry and RR-interval monitoring
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 14 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
thoracic surgery
Key exclusion criteria
The performance status is one or more.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Goto |
Organization
National Hospital Organization, Saitama Hospital
Division name
Department of General Thoracic Surgery
Zip code
351-0102
Address
2-1,Suwa,Wakou-shi,Saitamaken
TEL
048-462-1101
macro_model_med_in_toho@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Goto |
Organization
National Hospital Organization, Saitama Hospital
Division name
Department of General Thoracic Surgery
Zip code
351-0102
Address
2-1,Suwa,Wakou-shi,Saitamaken
TEL
048-462-1101
Homepage URL
macro_model_med_in_toho@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization, Saitama Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
National Hospital Organization, Saitama Hospital
Address
2-1,Suwa,Wakou-shi,Saitamaken
Tel
048-462-1101
macro_model_med_in_toho@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
| 2017 | Year | 04 | Month | 03 | 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 | 01 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study design is the observational study.
Management information
Registered date
| 2017 | Year | 04 | Month | 03 | Day |
Last modified on
| 2021 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030808
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
