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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035409
Receipt No. R000040243
Scientific Title Effect of non-supervised exercise training in NSCLC who underwent lung resection
Date of disclosure of the study information 2018/12/30
Last modified on 2018/12/30

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Basic information
Public title Effect of non-supervised exercise training in NSCLC who underwent lung resection
Acronym Exercise training for postoperative patients in lung cancer
Scientific Title Effect of non-supervised exercise training in NSCLC who underwent lung resection
Scientific Title:Acronym Exercise training for postoperative patients in lung cancer
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Chest surgery Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Effects of non-supervised exercise training of postoperative health related quality of life
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Health related quality of life
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group:
Walking training by using accelerometer and peripheral muscle training.
term: 12 weeks
time: 1 session 30-60 min, 3 times per week
Interventions/Control_2 Control group:
no intervention
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The adult patient that is possible to evaluated in patients of preoperative lung resection for lung cancer.
Informed consent was obtained from all
patients prior to participation in the study.
Key exclusion criteria Musculoskeletal impairment
Cerebral vascular disorder
Severe visually and hearing impairment
Severe postoperative complications (>Clavien-dindo class 2)
pneumonectomy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Oikawa
Organization Nagasaki University Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 1-7-1, Sakamoto, Nagasaki
TEL 095-819-7258
Email m-oikawa@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masato Oikawa
Organization Nagasaki University Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 1-7-1, Sakamoto, Nagasaki
TEL 095-819-7258
Homepage URL
Email m-oikawa@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization Nagasaki University Hospital
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
Address
Tel
Email

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
2018 Year 12 Month 30 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 Preinitiation
Date of protocol fixation
2019 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 30 Day
Last modified on
2018 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040243

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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