UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042075
Receipt number 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 2021/10/14 19:36:38

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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 or person

Institute

Kobe University

Institute

Department

Personal name



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

Value
https://center6.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