UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029491 |
|---|---|
| Receipt number | R000033684 |
| Scientific Title | Effects of inspiratory muscle training on exercise tolerance in hospitalized patients with chronic heart failure |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2024/03/17 21:49:18 |
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Basic information
Public title
Effects of inspiratory muscle training on exercise tolerance in hospitalized patients with chronic heart failure
Acronym
INSPIREX-CHF trial
Scientific Title
Effects of inspiratory muscle training on exercise tolerance in hospitalized patients with chronic heart failure
Scientific Title:Acronym
INSPIREX-CHF trial
Region
| Japan |
Condition
Condition
Hospitalized patients with chronic heart failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of inspiratory muscle training in hospitalized patients due to decompensated chronic heart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise tolerance (measuring at baseline, 2 weeks and 16 weeks)
Key secondary outcomes
Inspiratory muscle strength, ventilatory function, autonomic nervous activity, stress reaction, cardiac function (measuring at baseline, 2 weeks and 16 weeks)
Cardiopulmonary effects during the inspiratory muscle training
Sub group analysis: age >= 65 yrs, sex, LVEF >= 50%, baseline inspiratory muscle strength >= median value, frailty
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1) Usual cardiac rehabilitation
2) Inspiratory muscle training using an inspiratory muscle training device of one set of 20 to 30-time inspirations per day and seven days per week
Interventions/Control_2
1) Usual cardiac rehabilitation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with chronic heart failure who admitted due to decompensated heart failure
2) Aged 20 yrs or older
3) Maximal inspiratory pressure less than 80% of predictive value
Key exclusion criteria
1) Chronic respiratory diseases
2) Received thoracic surgery in the past 3 months
3) Severe pulmonary hypertension
4) Significant myocardial ischemia during low-intensity exercise
5) Acute infective endocarditis, myocarditis and pericaritis
6) Severe symptomatic aortic stenosis and mitral stenosis
7) Hypertrophic obstructive cardiomyopathy
8) Untreated life-threatening arrhythmia
9) Requiring high inotropic support
10) Patients with circulatory assist device
11) Untreated aortic aneurysm or aortic dissection
12) Patients undergoing hemodialysis
13) Short life expectancy due to advanced disease other than heart failure
14) Pregnant, lactational woman or patients may be pregnant
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Hamazaki |
Organization
Kitasato University Hospital
Division name
Department of Rehabilitation
Zip code
252-0375
Address
1-15-1, Kitasato, Minami-ku, Sagamihara
TEL
042-778-8413
hamanobu0317@gmail.com
Public contact
Name of contact person
| 1st name | Nobuaki |
| Middle name | |
| Last name | Hamazaki |
Organization
Kitasato University Hospital
Division name
Department of Rehabilitation
Zip code
252-0375
Address
1-15-1, Kitasato, Minami-ku, Sagamihara
TEL
042-778-8413
Homepage URL
hamanobu0317@gmail.com
Sponsor or person
Institute
Kitasato University Hoapital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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
Kitasato University Hospital
Address
1-15-1, Kitasato, Minami-ku, Sagamihara-city, Japan
Tel
0427788413
hamanobu0317@gmail.com
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
| 2017 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2017 | Year | 10 | Month | 10 | Day |
Last modified on
| 2024 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033684
