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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035756
Receipt No. R000040730
Official scientific title of the study Functional exercise capacity during the early period after lung resection for non-small cell lung cancer
Date of disclosure of the study information 2019/02/03
Last modified on 2019/02/03

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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