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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
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 | 2020/05/19 |
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 |
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Condition | |||
Condition | Non small cell lung cancer | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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.
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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. |
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Target sample size | 5 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |