UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057665 |
|---|---|
| Receipt number | R000065891 |
| Scientific Title | The effectiveness of inspiratory muscle training on respiratory function, respiratory muscle strength, and physical function in patients with cerebrovascular disease. |
| Date of disclosure of the study information | 2025/04/21 |
| Last modified on | 2025/04/21 13:05:31 |
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Basic information
Public title
The effectiveness of inspiratory muscle training on respiratory function, respiratory muscle strength, and physical function in patients with cerebrovascular disease.
Acronym
The effectiveness of inspiratory muscle training on respiratory function, respiratory muscle strength, and physical function in patients with cerebrovascular disease.
Scientific Title
The effectiveness of inspiratory muscle training on respiratory function, respiratory muscle strength, and physical function in patients with cerebrovascular disease.
Scientific Title:Acronym
The effectiveness of inspiratory muscle training on respiratory function, respiratory muscle strength, and physical function in patients with cerebrovascular disease.
Region
| Japan |
Condition
Condition
cerebrovascular disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to verify the effectiveness of inspiratory muscle training in prevented respiratory sarcopenia and improved physical functions in patients with primary cerebrovascular disease hospitalized in a rehabilitation unit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory muscle strength, Diaphragm muscle thickness
Key secondary outcomes
Respiratory functions, Muscle mass, One Leg Standing Test, Gait parameter
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
As part of their self-training, the participants perform inspiratory muscle training under loaded conditions for four weeks.
Interventions/Control_2
As part of their self-training, the participants perform inspiratory muscle training without loaded conditions for four weeks.
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 with initial cerebrovascular disease (however, asymptomatic patients are not excluded)
2) Patients with hemiplegia
3) Adults (18 years of age or older)
4) Patients admitted to rehabilitation unit
5) Patients without cognitive decline (Clinical Dementia Rating 0 points)
Key exclusion criteria
1) Patients compatible with respiratory function measuring equipment or training devices due to facial paralysis, missing teeth
2) Orthopedic diseases, neurological diseases, or impaired coordination that may affect the One Leg Standing Test
3) Chronic obstructive pulmonary disease
4) Cardiovascular diseases that require restrictions on exercise
5) Wearing cardiac pacemakers
6) not able to give informed consent
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Yoshino |
| Middle name | |
| Last name | Terui |
Organization
Akita University Graduate School of Health Sciences
Division name
Physical Therapy
Zip code
010-8543
Address
1-1-1, Hondo, Akita City, Akita, Japan.
TEL
018-884-6504
terui@hs.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshino |
| Middle name | |
| Last name | Terui |
Organization
Akita University Graduate School of Health Sciences
Division name
Physical Therapy
Zip code
010-8543
Address
1-1-1, Hondo, Akita City, Akita, Japan.
TEL
018-884-6504
Homepage URL
terui@hs.akita-u.ac.jp
Sponsor or person
Institute
Akita Prefectural Center for Rehabilitation and Psychiatric Medicine
Institute
Department
Personal name
Yohei Konno
Funding Source
Organization
Akita University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
ORPHE Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akita Prefectural Center for Rehabilitation and Psychiatric Medicine
Address
352 Gohyakukarita, Kamiyodogawa, Kyouwa, Daisen, Akita, Japan.
Tel
018-892-3751
terui@hs.akita-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
| 2025 | Year | 04 | Month | 21 | 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
| 2025 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 21 | Day |
Last modified on
| 2025 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065891
