UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036363 |
|---|---|
| Receipt number | 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 | 2020/06/05 18:44:55 |
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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
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
magagi1226@yahoo.co.jp
Sponsor or person
Institute
Seirei Mikatahara General Hospital
Institute
Department
Personal name
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
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
No longer recruiting
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
| 2020 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041429
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
