UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034894 |
|---|---|
| Receipt number | 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 | 2020/05/19 09:09:04 |
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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 | 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
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
pac1029a@gmail.com
Sponsor or person
Institute
Tsukuba University Hospital
Institute
Department
Personal name
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
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
5
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
| 2018 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 15 | Day |
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
| 2020 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039765
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