UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of exercise therapy using Nordic walking before and after non-small cell lung cancer resection and its effectiveness as an exercise tool after discharge
Acronym	Efficacy of exercise therapy using Nordic walking before and after non-small cell lung cancer resection and its effectiveness as an exercise tool after discharge
Scientific Title	Efficacy of exercise therapy using Nordic walking before and after non-small cell lung cancer resection and its effectiveness as an exercise tool after discharge
Scientific Title:Acronym	Efficacy of exercise therapy using Nordic walking before and after non-small cell lung cancer resection and its effectiveness as an exercise tool after discharge
Region	Japan

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

Objectives
Narrative objectives1	We conducted a rehabilitation intervention before the operation using Nordic walking, suppressed the decline of physical ability and motor function after lung cancer resection surgery and whether it is possible to form continuous exercise habits even after discharge Will be examined. However, the effect of Nordic walking on the physical and motor skills of patients scheduled for lung cancer resection is unknown. In this research, before the large-scale research implementation, the purpose is to examine the effect of Nordic walking on the improvement of physical ability and motor ability and whether it is effective as a continuing movement exercise after discharging.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	All research participants will evaluate physical ability / motor ability, lung function, quality of life (QOL) 3 weeks before surgical lung cancer resection surgery, 1 day before surgical lung cancer resection, 4 weeks after surgery, and 3 months later. 6 minutes walking Incremental Shuttle Walking Test Knee joint extension strength Pulmonary function test SF-36 (MOS 36-item Short-Form Health Survey)
Key secondary outcomes	Body composition Grip strength

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Three weeks before surgical lung cancer resection surgery, exercise therapy using Nordic walking will be done. From surgical lung cancer resection surgery to discharge, the standard lung cancer postoperative rehabilitation program prescribed by the Rehabilitation Department is applied.
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Five patients who are diagnosed as non-small cell carcinoma (Stages I and II) and are adapted for surgical resection of lobectomy are included.
Key exclusion criteria	1) Patients suffering from orthopedic diseases whose movement and the like are restricted 2) Patients with poorly controlled heart disease 3) Patients who have had a history of pulmonary resection in the past 4) have active bacterial and fungal infections 5) Pregnant women or lactating women 6) Patients with a history of serious drug allergy 7) Psychiatric disorders or psychiatric symptoms are merged and it is judged difficult to participate in the study. 8) Other patients judged to be inappropriate for participation in this study by the attending physician.
Target sample size	5

Research contact person
Name of lead principal investigator	1st name yasushi Middle name Last name Hada
Organization	Tsukuba University Hospital
Division name	Department of Rehabilitation
Zip code	3058576
Address	2-1-1 Amakubo Tsukuba, Ibaraki prefecture
TEL	029-853-3900
Email	y-hada@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Jaesik Middle name Last name Lee
Organization	Tsukuba University Hospital
Division name	Department of Rehabilitation
Zip code	3058576
Address	2-1-1 Amakubo Tsukuba, Ibaraki prefecture
TEL	029-853-3900
Homepage URL
Email	pac1029a@gmail.com

Sponsor
Institute	Tsukuba University Hospital
Institute
Department

Funding Source
Organization	Tsukuba University
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	Tsukuba University Hospital
Address	2-1-1 Amakubo Tsukuba, Ibaraki prefecture
Tel	029-853-3900
Email	pac1029a@gmail.com

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 11 Month 15 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	2018 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date	2018 Year 11 Month 15 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 14 Day
Last modified on	2019 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039765

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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