UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Functional exercise capacity during the early period after lung resection for non-small cell lung cancer
Title of the study (Brief title)	Functional exercise capacity in patients who undergo lung resection
Region	Japan

Condition
Condition	the patients of non-small cell lung cancer
Classification by specialty	Chest surgery Rehabilitation medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aims of this study were to identify the magnitude of decline in 6 minute walk distance (6MWD) as a measure of functional exercise capacity, and associations between the changes in 6MWD and pre and postoperative factors.
Basic objectives2	Others
Basic objectives -Others	survey
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	6-minute walk distance within 2 days prior to surgery and within the first 7 days postoperatively.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Consecutive patients with preoperative clinical stage I to IIIA NSCLC who underwent lung resection at Nagasaki University Hospital
Key exclusion criteria	comorbid conditions in preoperation severe postoperative complications pneumonectomy, or had a history of thoracic surgery.
Target sample size	400

Research contact person
Name of lead principal investigator	Masato Oikawa
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Cardiopulmonary Rehabilitation Science
Address	1-7-1, Sakamoto, Nagasaki
TEL	095-819-7963
Email	m-oikawa@nagasaki-u.ac.jp

Public contact
Name of contact person	Masato Oikawa
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Cardiopulmonary Rehabilitation Science
Address	1-7-1, Sakamoto, Nagasaki
TEL	095-819-7963
Homepage URL
Email	m-oikawa@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	Science Research from Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 02 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 01 Month 04 Day
Anticipated trial start date	2011 Year 04 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	observational study

Management information
Registered date	2019 Year 02 Month 03 Day
Last modified on	2019 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040730