UMIN-CTR Clinical Trial

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
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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
Email	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
Email	macro_model_med_in_toho@yahoo.co.jp

Sponsor
Institute	National Hospital Organization, Saitama Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030808