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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036363
Receipt No. R000041429
Scientific Title The influence on muscle dysfunction after thoracic surgery and respiratory complications after surgery and development of a rehabilitation program for the purpose of improving muscle function.
Date of disclosure of the study information 2019/03/31
Last modified on 2019/03/31

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Basic information
Public title The influence on muscle dysfunction after thoracic surgery and respiratory complications after surgery and development of a rehabilitation program for the purpose of improving muscle function.
Acronym The influence on muscle dysfunction after thoracic surgery and respiratory complications after surgery and development of a rehabilitation program for the purpose of improving muscle function.
Scientific Title The influence on muscle dysfunction after thoracic surgery and respiratory complications after surgery and development of a rehabilitation program for the purpose of improving muscle function.
Scientific Title:Acronym The influence on muscle dysfunction after thoracic surgery and respiratory complications after surgery and development of a rehabilitation program for the purpose of improving muscle function.
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The influence of inspiratory muscle training before thoracic surgery on respiratory complications after surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of respiratory complications
Key secondary outcomes Inspiratory muscle strength, lung function, cough strength, swallowing function

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 Standard preoperative instruction and 2 weeks preoperative inspiratory muscle training.
Interventions/Control_2 Standard preoperative instruction.
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
89 years-old >=
Gender Male and Female
Key inclusion criteria Patients who received 2 weeks of inspiratory muscle training before surgery and physiotherapy after surgery.
Key exclusion criteria Preoperative exercise is contraindicated, unstable angina, uncontrolled arrhythmia, postoperative hemodynamic instability, cognitive decline.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Masaki
Middle name
Last name Oomagari
Organization Seirei Mikatahara General Hospital
Division name Department of Rehabilitation Medicine
Zip code 433-8558
Address 3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka
TEL 053-436-1251
Email magagi1226@yahoo.co.jp

Public contact
Name of contact person
1st name Malaki
Middle name
Last name Oomagari
Organization Seirei Mikatahara General Hospital
Division name Department of Rehabilitation Medicine
Zip code 433-8558
Address 3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka
TEL 053-436-1251
Homepage URL
Email magagi1226@yahoo.co.jp

Sponsor
Institute Seirei Mikatahara General Hospital
Institute
Department

Funding Source
Organization None
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 Seirei Mikatahara General Hospital
Address 3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka
Tel 053-436-1251
Email magagi1226@yahoo.co.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 聖隷三方原病院(静岡県) 

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 31 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 Enrolling by invitation
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
2016 Year 05 Month 20 Day
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2020 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 31 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041429

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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