UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the effect of exercise tolerance decline after lung resection on the prognosis
Title of the study (Brief title)	Investigation of the effect of exercise tolerance decline after lung resection on the prognosis
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigation of the effect of exercise tolerance decline after lung resection on the prognosis
Basic objectives2	Others
Basic objectives -Others	Prognosis
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	- a length of time from surgery to hospital readmission
Key secondary outcomes	- a length of time from surgery to death - 6-minute walk distance at before and after surgical operation - grip at before and after surgical operation

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	43 years-old <=
Age-upper limit	86 years-old >=
Gender	Male and Female
Key inclusion criteria	Cases that received a lung resection in lung cancer and experienced rehabilitation program by physical therapist in our hospital
Key exclusion criteria	Cases that could not be performed 6-minute walk test before and after surgery operation
Target sample size	99

Research contact person
Name of lead principal investigator	Haruki Maniwa
Organization	Matsue Red Cross Hospital
Division name	Rehabilitation
Address	200, Horo, Matsue, Shimane, Japan
TEL	0852-24-2111
Email	maniwa_h@yahoo.co.jp

Public contact
Name of contact person	Haruki Maniwa
Organization	Matsue Red Cross Hospital
Division name	Rehabilitation
Address	200, Horo, Matsue, Shimane, Japan
TEL	0852-24-2111
Homepage URL
Email	maniwa_h@yahoo.co.jp

Sponsor
Institute	Matsue Red Cross Hospital
Institute
Department

Funding Source
Organization	nothing
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	2019 Year 01 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 01 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date
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	We analyzed 99 samples. We indicated that the 6-minute walk distance shortening of 30m or more after lung resection compared pre-surgery affects hospital readmission within 1 year after surgery.

Management information
Registered date	2019 Year 01 Month 25 Day
Last modified on	2019 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040640