UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044779 |
|---|---|
| Receipt number | R000051077 |
| Scientific Title | Functional exercise capacity and related factors 4 weeks after Lung resection in patients with non-small cell lung cancer |
| Date of disclosure of the study information | 2021/07/07 |
| Last modified on | 2024/07/09 12:43:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Functional exercise capacity in non-small cell lung cancer patients four week after lung resection
Acronym
Functional exercise capacity in patients who undergo lung resection after four week
Scientific Title
Functional exercise capacity and related factors 4 weeks after Lung resection in patients with non-small cell lung cancer
Scientific Title:Acronym
Functional exercise capacity in patients who undergo lung resection after four week
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
To evaluate the 6-minute walking distance as functional exercise capacity at discharge and 4 weeks after lung resection, and to clarify the change from the preoperative period.
To determine the factors associated with non-improvement of functional exercise capacity.
Basic objectives2
Others
Basic objectives -Others
survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6-minute walk distance before surgery, at discharge, and 4 weeks after surgery
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
Patients who had been notified of cancer and were admitted to the Department of Respiratory Surgery at the JRC Nagasaki Genbaku Hospital for pneumonectomy for non-small cell lung cancer were followed up at the same hospital after surgery.
Key exclusion criteria
If the attending physician considers the patient's psychological condition to be inappropriate.
Postoperative complications [Clavien-Dindo classification (v2.0) grade 3b or higher] that may affect the assessment of physical function.
Patients undergoing total pneumonectomy
Patients with serious comorbidities or cognitive dysfunction that make it difficult to assess physical function and questionnaires.
Patients with severe hearing or visual impairment that would make physical function assessment or questionnaire assessment difficult.
Difficulty in understanding the purpose of the study and communication
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Toshiro |
| Middle name | |
| Last name | Matsuzaki |
Organization
Japanese Red Cross Society Nagasaki Genbaku Hospital
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Rehabilitation
Zip code
852-8511
Address
3-15 mori-mati, nagasaki-si, nagasaki-ken
TEL
095-847-1511
wrqfb435@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Toshiro |
| Middle name | |
| Last name | Matsuzaki |
Organization
Japanese Red Cross Society Nagasaki Genbaku Hospital
Division name
Department of Rehabilitation
Zip code
852-8511
Address
3-15 mori-mati, nagasaki-si, nagasaki-ken
TEL
095-847-1511
Homepage URL
wrqfb435@yahoo.co.jp
Sponsor or person
Institute
Japanese Red Cross Society Nagasaki Genbaku Hospital
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
no
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
Nagasaki University Graduate School of Biomedical Sciences
Address
1-12-4 sakamoto-mati, nagasaki-si, nagasaki-ken
Tel
095-819-7195
gakujutu_gakuji@ml.nagasaki-u.ac.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
日本赤十字社長崎原爆病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 07 | 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
| 2021 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2021 | Year | 07 | Month | 07 | Day |
Last modified on
| 2024 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051077
