UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054767 |
|---|---|
| Receipt number | R000062587 |
| Scientific Title | Efficacy and safety of inspiratory muscle training in hospitalized patients with acute-phase decompensated acute heart failure: A prospective single-arm study compared to historical control data. |
| Date of disclosure of the study information | 2024/06/25 |
| Last modified on | 2024/08/04 15:48:17 |
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Basic information
Public title
Efficacy and safety of inspiratory muscle training in hospitalized patients with acute-phase decompensated acute heart failure: A prospective single-arm study compared to historical control data.
Acronym
IMT-AHF-single arm study
Scientific Title
Efficacy and safety of inspiratory muscle training in hospitalized patients with acute-phase decompensated acute heart failure: A prospective single-arm study compared to historical control data.
Scientific Title:Acronym
IMT-AHF-single-arm study
Region
| Japan |
Condition
Condition
Hospitalization patients with acute heart failure
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of inspiratory muscle training in hospitalized patients with acute heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2-minute walk distance
Key secondary outcomes
The safety of inspiratory muscle training
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 admitted due to a diagnosis of acute heart failure and prescribed cardiac rehabilitation by a physician.
2) Patients who have inspiratory muscle weakness on examination at the start of cardiac rehabilitation
3) Patients who are implementable the 2-minute walk test on the examination at the start of cardiac rehabilitation.
Key exclusion criteria
1) inability to walk independently before admission
2) severe heart failure requiring intensive care such as circulatory support, ventilator, noninvasive positive pressure ventilation, hemodialysis, and intra-aortic balloon pumping
3) severe aortic valve stenosis
4) obstructive hypertrophic cardiomyopathy
5) poorly controlled arrhythmia causing hemodynamic abnormalities
6) inability to measure inspiratory muscle strength due to severe respiratory muscle weakness or the presence of a respiratory or neuromuscular disease that affects respiratory muscle strength (e.g., chronic obstructive pulmonary disease, myasthenia gravis)
7) impairment due to stroke, injury, or other medical condition that precludes participation in the measurement
8) anticipated hospital discharge before baseline study measures could be completed.
Target sample size
49
Research contact person
Name of lead principal investigator
| 1st name | Ren |
| Middle name | |
| Last name | Takahashi |
Organization
Hirosaki University Graduate School of Health Sciences
Division name
Division of Comprehensive Rehabilitation Sciences
Zip code
036-8564
Address
Honcho 66-1, Hirosaki, Aomori
TEL
022-293-1111
h24dh405@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ren |
| Middle name | |
| Last name | Takahashi |
Organization
Hirosaki University Graduate School of Health Sciences
Division name
Division of Comprehensive Rehabilitation Sciences
Zip code
036-8564
Address
Honcho 66-1, Hirosaki, Aomori
TEL
022-293-1111
Homepage URL
h24dh405@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Health Sciences
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
Hirosaki University Graduate School of Health Sciences Ethics Committee
Address
Honcho 66-1, Hirosaki, Aomori
Tel
0172-33-5111
jm5910@hirosaki-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
| 2024 | Year | 06 | Month | 25 | 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
39
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
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Cohort study, subject recruitment method (all patients who visited our facility between November 2022 and March 2024 and met the inclusion criteria), historical control group used as control group,
Management information
Registered date
| 2024 | Year | 06 | Month | 25 | Day |
Last modified on
| 2024 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062587
