UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062119 |
|---|---|
| Receipt number | R000071064 |
| Scientific Title | A Prospective Observational Study on Physical Activity Levels in Patients with Lung Cancer Undergoing Lung Resection |
| Date of disclosure of the study information | 2026/07/02 |
| Last modified on | 2026/07/02 13:45:28 |
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Basic information
Public title
A Prospective Observational Study on Physical Activity Levels in Patients with Lung Cancer Undergoing Lung Resection
Acronym
Preoperative Physical Activity Levels in Patients with Lung Cancer
Scientific Title
A Prospective Observational Study on Physical Activity Levels in Patients with Lung Cancer Undergoing Lung Resection
Scientific Title:Acronym
Preoperative Physical Activity Levels in Patients with Lung Cancer
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery | Rehabilitation medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate preoperative physical activity levels using accelerometers in patients with lung cancer scheduled for lung resection and to examine the association between preoperative physical activity levels and postoperative complications and disability-free survival.
Basic objectives2
Others
Basic objectives -Others
To evaluate pre- and postoperative functional status longitudinally and measure the disability-free survival period
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional status six months post-surgery: WHO-DAS 2.0
Key secondary outcomes
Preoperative physical activity levels: sedentary time (sedentary behavior), physical activity time (moderate-to-vigorous physical activity)
Postoperative pulmonary complications
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with primary non-small cell lung cancer, or those strongly suspected of having it, who are scheduled for lung resection
2. Patients who are 18 years of age or older at the time consent is obtained
3. Patients with a waiting period of at least 2 weeks before surgery
4. Patients from whom written consent to participate in this study can be obtained
Key exclusion criteria
1. Patients with active duplicate cancers
2. Patients with a history of cerebrovascular disease within the past 6 months
3. Patients with severe liver or kidney disease, or poorly controlled endocrine disorders
4. Patients with a history of or concurrent severe psychiatric disorders
5. Patients whose lesions were determined not to be lung cancer based on the final pathological diagnosis
6. Patients deemed ineligible for participation in this study by the principal investigator or other investigators
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Nanako |
| Middle name | |
| Last name | Hijikata |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3833
keiorehab@gmail.com
Public contact
Name of contact person
| 1st name | Mukyo |
| Middle name | |
| Last name | Abe |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3833
Homepage URL
keiorehab@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
None
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
Keio University Faculty of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: Prospective Cohort Study
Management information
Registered date
| 2026 | Year | 07 | Month | 02 | Day |
Last modified on
| 2026 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071064
