UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055242 |
|---|---|
| Receipt number | R000063124 |
| Scientific Title | Diaphragm dysfunction and related factors in patients with chronic heart failure |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/08/15 09:15:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Reduced inspiratory muscle strength and related factors in patients with heart failure
Acronym
Reduced inspiratory muscle strength in patients with heart failure
Scientific Title
Diaphragm dysfunction and related factors in patients with chronic heart failure
Scientific Title:Acronym
Diaphragm function in patients with chronic heart failure
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the factors associated with diaphragmatic dysfunction in patients with chronic heart failure using ultrasound imaging.
Basic objectives2
Others
Basic objectives -Others
To investigate the association between thickening ratio of the diaphragm, forced lung capacity, respiratory muscle strength, the breathing movement scale, and sarcopenia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Thickening fraction of the diaphragm (period of stable symptoms)
Key secondary outcomes
Forced vital capacity, respiratory muscle strength (maximum inspiratory and expiratory pressures), chest and abdominal mobility (the breathing movement scale), sarcopenia (skeletal muscle index, grip power, five-time chair-stand test), left ventricular ejection fraction (period of stable symptoms)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Symptomatically stable inpatient with chronic heart failure
Key exclusion criteria
Symptomatically unstable inpatient with chronic heart failure and inpatients with measurement difficulties due to physical or cognitive impairments
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Kaneko |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences at Fukuoka
Zip code
831-8501
Address
137-1 Enokizu, Okawa-shi, Fukuoka, Japan
TEL
0944-89-2000
hkaneko@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hideo |
| Middle name | |
| Last name | Kaneko |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences at Fukuoka
Zip code
831-8501
Address
137-1 Enokizu, Okawa-shi, Fukuoka, Japan
TEL
0944-89-2000
Homepage URL
hkaneko@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Kaneko Hideo
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
International University of Health and Welfare
Address
137-1 Enokizu, Okawa-shi, Fukuoka, Japan
Tel
0944-89-2000
q-rinri@ihwg.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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, diaphragmatic function, pulmonary function, breathing movement, respiratory muscle strength, and sarcopenia will be evaluated in symptomatically stable chronic heart failure inpatients, and the associated factors of diaphragmatic dysfunction as determined from ultrasound imaging will be examined.
Management information
Registered date
| 2024 | Year | 08 | Month | 14 | Day |
Last modified on
| 2025 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063124
