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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034894
Receipt No. R000039765
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
Date of disclosure of the study information 2018/11/15
Last modified on 2018/11/14

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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
Middle name
Last name Hada yasushi
Organization Tsukuba University Hospital
Division name Department of Rehabilitation
Zip code
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
Middle name
Last name Lee Jaesik
Organization Tsukuba University Hospital
Division name Department of Rehabilitation
Zip code
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
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 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
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
2018 Year 11 Month 14 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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