UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014229 |
|---|---|
| Receipt number | R000016058 |
| Scientific Title | Effect of inspiratory muscle traning on exercise tolerance in patients with heart failure with preserved ejection fraction |
| Date of disclosure of the study information | 2014/06/11 |
| Last modified on | 2022/10/07 15:02:54 |
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Basic information
Public title
Effect of inspiratory muscle traning on exercise tolerance in patients with heart failure with preserved ejection fraction
Acronym
Effect of inspiratory muscle traning on exercise tolerance in patients with heart failure with preserved ejection fraction
Scientific Title
Effect of inspiratory muscle traning on exercise tolerance in patients with heart failure with preserved ejection fraction
Scientific Title:Acronym
Effect of inspiratory muscle traning on exercise tolerance in patients with heart failure with preserved ejection fraction
Region
| Japan |
Condition
Condition
patients with heart failure with preserved ejection fraction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effeciency of inspiratory muscle traning in patients with heart failure with preserved ejection fraction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
exercise tolelance
physical activity
changes in QOL and depression scores
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Inspiratory muscle training
20minutes /day during 24weeks
Interventions/Control_2
control
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
Patients with heart failure with preserved ejection fraction who have New York Heart Failure Association Class 2 or 3
Key exclusion criteria
1 patients with cancer
2 patients with previous history of acute coronary syndrome or cardiac surjery within three mounths
3 patients with impaired motor function due to cerebral vascular diseases or orthopedic diseases
4 patients receiving steroid hormone
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Department of Molecular Medicine and Therapeutics
Division name
Division of Cardiovascular Medicine
Zip code
6838504
Address
36-1 Nishicho, Yonago
TEL
0859386517
ykazuhiro@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Kinugasa |
Organization
Department of Molecular Medicine and Therapeutics, Tottori University
Division name
Division of Cardiovascular Medicine
Zip code
683-0805
Address
8-15-44
TEL
0859228596
Homepage URL
ykinugas-circ@umin.ac.jp
Sponsor or person
Institute
Department of Molecular Medicine and Therapeutics, Tottori University
Institute
Department
Personal name
Funding Source
Organization
Department of Molecular Medicine and Therapeutics, Tottori University
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
Tottori University
Address
nishicho 36-1
Tel
0859386517
ykinugasa-circ@umin.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
| 2014 | Year | 06 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 11 | Day |
Last modified on
| 2022 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016058
