UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062253 |
|---|---|
| Receipt number | R000071233 |
| Scientific Title | Effects of inspiratory muscle training on respiratory function and quality of life after minimally invasive cardiac surgery: a single-center randomized controlled trial |
| Date of disclosure of the study information | 2026/07/16 |
| Last modified on | 2026/07/16 00:10:27 |
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Basic information
Public title
Effects of inspiratory muscle training on respiratory function and quality of life after minimally invasive cardiac surgery
Acronym
MICS-IMT Trial
Scientific Title
Effects of inspiratory muscle training on respiratory function and quality of life after minimally invasive cardiac surgery: a single-center randomized controlled trial
Scientific Title:Acronym
MICS-IMT Trial
Region
| Japan |
Condition
Condition
Valvular heart disease or ischemic heart disease
Classification by specialty
| Cardiovascular surgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of inspiratory muscle training on respiratory function and quality of life in patients after minimally invasive cardiac surgery (MICS).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximal inspiratory pressure at hospital discharge
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Inspiratory muscle training plus usual rehabilitation
Interventions/Control_2
Usual rehabilitation alone
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients scheduled to undergo elective minimally invasive cardiac surgery (MICS).
2. Men and women aged 18 years or older.
3. Patients who provide written informed consent.
Key exclusion criteria
1. Patients with preoperative dependence in activities of daily living (Barthel Index <100).
2. Patients with a history of chronic pulmonary disease.
3. Patients with a history of cerebrovascular disease accompanied by neurological deficits (e.g., motor paralysis).
4. Patients who develop major postoperative complications, such as myocardial infarction or cerebral infarction.
5. Patients who require reintubation or develop postoperative pulmonary complications.
6. Patients with dementia or psychiatric disorders that impair their ability to understand or perform inspiratory muscle training.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka International Medical & Science Center Osaka Keisatsu Hospital
Division name
Department of Rehabilitation Medicine
Zip code
543-8922
Address
2-6-40 Karasugatsuji, Tennoji-ku, Osaka 543-8922, Japan
TEL
06-6771-6051
tanaka.kohei30@oim.or.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka International Medical & Science Center Osaka Keisatsu Hospital
Division name
Department of Rehabilitation Medicine
Zip code
543-8922
Address
2-6-40 Karasugatsuji, Tennoji-ku, Osaka 543-8922, Japan
TEL
06-6771-6051
Homepage URL
tanaka.kohei30@oim.or.jp
Sponsor or person
Institute
Osaka International Medical & Science Center
Institute
Department
Personal name
Funding Source
Organization
Osaka International Medical & Science Center
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Police Hospitals Ethics Committee
Address
2-6-40 Karasugatsuji, Tennoji-ku, Osaka 543-8922, Japan
Tel
06-6771-6051
tiken-jim@oim.or.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
| 2026 | Year | 07 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 16 | Day |
Last modified on
| 2026 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071233
