UMIN-CTR Clinical Trial

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	Japan

Condition
Condition	Esophageal Cancer
Classification by specialty	Gastrointestinal surgery
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	Device,equipment
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	40 years-old <=
Age-upper limit	Not applicable
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
Key exclusion criteria	1) Esophagectomy of two phases operation and cervical esophageal cancer patients. 2) Disorientation or Dementia
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Ishikawa
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
Email	ishikawa@bear-kobe.u.ac.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Ishikawa
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
Email	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
Email	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	2020 Year 12 Month 01 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	Open public recruiting
Date of protocol fixation	2020 Year 04 Month 15 Day
Date of IRB	2020 Year 06 Month 16 Day
Anticipated trial start date	2020 Year 05 Month 31 Day
Last follow-up date	2024 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 11 Day
Last modified on	2021 Year 10 Month 14 Day

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

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