UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055454 |
|---|---|
| Receipt number | R000063034 |
| Scientific Title | Efficacy of inspiratory muscle training in older patients with Acute Heart Failure: multi-arm randomized controlled trial |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/10/02 19:29:15 |
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Basic information
Public title
Efficacy of inspiratory muscle training in older patients with Acute Heart Failure: multi-arm randomized controlled trial
Acronym
IMT-AHF trial
Scientific Title
Efficacy of inspiratory muscle training in older patients with Acute Heart Failure: multi-arm randomized controlled trial
Scientific Title:Acronym
IMT-AHF trial
Region
| Japan |
Condition
Condition
Older patients with acute heart failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether inspiratory muscle training is effective in improving exercise tolerance for acute heart failure patients with inspiratory muscle weakness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2-minute walk distance (measured at baseline and at discharge)
Key secondary outcomes
Change in dyspnea and lower-limb fatigue before and after 2-minute walk distance, EuroQol 5-dimensional 5-level, physical activity, inspiratory and expiratory muscle strength, diaphragm thickness, tongue pressure, and respiratory sarcopenia (measured at baseline and at discharge)
Number and type of adverse events and changes in vital signs with inspiratory muscle training
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
High intensity nspiratory muscle training
Duration: From study enrollment to discharge
Load: PI-max 60%.
Times: 15 times per session, 3 sets per day
Frequency: at least 5 days per week
Interventions/Control_2
Low intensity inspiratory muscle training
Duration: From study enrollment to discharge
Load: PI-max 30%.
Times: 15 times per session, 3 sets per day
Frequency: at least 5 days per week
Interventions/Control_3
Sham inspiratory muscle training
Duration: From study enrollment to discharge
Load: PI-max 0%.
Times: 15 times per session, 3 sets per day
Frequency: at least 5 days per week
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients over 65 years old admitted to the National Hospital Organization Sendai Medical Center with a diagnosis of acute heart failure and prescribed cardiac rehabilitation by a physician.
2)Patients who have been informed about the study and obtained written consent from the individual.
3)Patients who have inspiratory muscle weakness on examination at the start of cardiac rehabilitation
4)Patients who are implementable the 2-minute walk test on the examination at the start of cardiac rehabilitation.
Key exclusion criteria
1)Acute myocardial infarction
2)Requiring care in an intensive care unit
3)Severe dementia
4)Impairment from stroke, injury, impaired consciousness, psychiatric disorder or other medical disorder that precludes participation in the intervention
5)Advanced chronic kidney disease (eGFR < 20 mL/min/1.73 m2) or dialysis
6)Prior cardiac transplantation or planned within the next 6 months
7)Expected use of continuous intravenous inotropic therapy after discharge
8)VAD, IMPELLA, or IABP is required or anticipated within the next 6 months
9)Expected use of continuous intravenous inotropic therapy after discharge
10)Uncontrolled diabetes (HbA1c > 8.4%)
11)Peripheral arterial disease (Fontain III or IV)
12)Severe anemia (hemoglobin < 8.0g/dl)
13)Patients who needed assistance for walking a month before hospitalization
14)Patients with mechanical ventilation and non-invasive positive pressure ventilation
15)Diseases and clinical conditions that are absolute contraindications to aggressive exercise training
-Unstable angina or low-threshold myocardial ischemia induced by slow walking (2 METs) on a flat surface
-Uncontrolled arrhythmias causing hemodynamic abnormalities (ventricular fibrillation, sustained ventricular tachycardia)
-Severe valvular disease indicated for surgery, especially symptomatic aortic stenosis
-Severe left ventricular outflow tract stenosis due to obstructive hypertrophic cardiomyopathy, etc.
-Acute pulmonary embolism, pulmonary infarction and deep vein thrombosis
-Active myocarditis, pericarditis, endocarditis
-Acute systemic disease
-Acute aortic dissection
-Moderate or severe aortic aneurysm
-Severe hypertension
-Thrombophlebitis
-Embolism within 2 weeks
-Serious organ diseases
-Mental or physical impairment that interferes with safe implementation of exercise training
16)Diseases affecting respiratory muscle strength
-Neuromuscular diseases
-Respiratory diseases
17)Orthopedic diseases affecting gait
Target sample size
66
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
Other
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 10 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | 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
| 2024 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063034
