UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035756 |
|---|---|
| Receipt number | R000040730 |
| Scientific Title | 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 00:47:09 |
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Basic information
Public title
Functional exercise capacity during the early period after lung resection for non-small cell lung cancer
Acronym
Functional exercise capacity in patients who undergo lung resection
Scientific Title
Functional exercise capacity during the early period after lung resection for non-small cell lung cancer
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masato Oikawa |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Cardiopulmonary Rehabilitation Science
Zip code
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7963
m-oikawa@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Oikawa |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Cardiopulmonary Rehabilitation Science
Zip code
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7963
Homepage URL
m-oikawa@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2011 | Year | 01 | Month | 04 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040730
