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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000042075 |
Receipt No. | R000047874 |
Scientific Title | Validation of Inspiratory Muscle Training before esophagectomy for esophageal cancer. |
Date of disclosure of the study information | 2020/12/01 |
Last modified on | 2020/10/01 |
Basic information | ||
Public title | Validation of Inspiratory Muscle Training before esophagectomy for esophageal cancer. | |
Acronym | Validation of Inspiratory Muscle Training before esophagectomy for esophageal cancer. | |
Scientific Title | Validation of Inspiratory Muscle Training before esophagectomy for esophageal cancer. | |
Scientific Title:Acronym | Validation of Inspiratory Muscle Training before esophagectomy for esophageal cancer. | |
Region |
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Condition | ||
Condition | Esophageal Cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the effect of Inspiratory Muscle Training before esophagectomy for esophageal cancer. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Maximal Inspiratory Pressure |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Single blind -participants are blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Setting Inspiratory Muscle Training for more than 4weeks before esophagectomy for esophageal cancer. | |
Interventions/Control_2 | Setting Incentive Spirometry for more than 4weeks before esophagectomy for esophageal cancer. | |
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 | The patients of esophageal cancer filled out under the inclusion criteria.
1)The patient above the age of 40 years old and might be received esophagectomy. 2)No comorbidity in organs. 3)Performance Scale is I or II |
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Key exclusion criteria | 1) Esophagectomy of two phases operation and cervical esophageal cancer patients.
2) Disorientation or Dementia |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kobe University | ||||||
Division name | Graduates School of Health Science | ||||||
Zip code | 654-0142 | ||||||
Address | 7-10-2 Tomogaoka,Suma-ku Kobe,Hyogo,Japan | ||||||
TEL | 078-796-4564 | ||||||
ishikawa@bear-kobe.u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kobe University | ||||||
Division name | Graduates School of Health Science | ||||||
Zip code | 654-0142 | ||||||
Address | 7-10-2 Tomogaoka,Suma-ku Kobe,Hyogo,Japan | ||||||
TEL | 078-796-4564 | ||||||
Homepage URL | |||||||
ishikawa@bear-kobe.u.ac.jp |
Sponsor | |
Institute | Kobe University |
Institute | |
Department |
Funding Source | |
Organization | Self-funding |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Kobe University Health Science Ethics Committee |
Address | 7-10-2 Tomogaoka,Suma-ku Kobe,Hyogo,Japan |
Tel | 078-796-4502 |
syomu2@ams.kobe-u.ac.jp |
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 | 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 | Enrolling by invitation | ||||||
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 | |||||||
Date trial data considered complete | |||||||
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=R000047874 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |