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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012064
Receipt No. R000014104
Scientific Title Effect of inspiratory muscle traning on exercise tolerance in elderly patients with heart failure
Date of disclosure of the study information 2013/10/17
Last modified on 2018/04/21

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Basic information
Public title Effect of inspiratory muscle traning on exercise tolerance in elderly patients with heart failure
Acronym Effect of inspiratory muscle traning on exercise tolerance in elderly patients with heart failure
Scientific Title Effect of inspiratory muscle traning on exercise tolerance in elderly patients with heart failure
Scientific Title:Acronym Effect of inspiratory muscle traning on exercise tolerance in elderly patients with heart failure
Region
Japan

Condition
Condition patients with heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effeciency of inspiratory muscle traning in elderly patients with heart failure
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes exercise tolarance
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
Behavior,custom
Interventions/Control_1 Inspiratory muscle traning
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria chronic heart failure with New York Heart Failure Class2 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
Middle name
Last name Kazuhiro Yamamoto
Organization Department of Molecular Medicine and Therapeutics
Division name Division of Cardiovascular Medicine
Zip code
Address 36-1 Nishicho, Yonago
TEL 0859-38-6517
Email ykazuhiro@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiharu Kinugasa
Organization Department of Molecular Medicine and Therapeutics, Tottori University
Division name Division of Cardiovascular Medicine
Zip code
Address 36-1 Nishicho, Yonago
TEL 0859-38-6517
Homepage URL
Email ykinugas-circ@umin.ac.jp

Sponsor
Institute Department of Molecular Medicine and Therapeutics, Tottori University
Institute
Department

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
Address
Tel
Email

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
2013 Year 10 Month 17 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 Completed
Date of protocol fixation
2013 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 10 Month 17 Day
Last modified on
2018 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014104

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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