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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034068
Receipt No. R000038832
Scientific Title The efficacy of interval walking training in rehabilitation medicine for mild heart failure patients
Date of disclosure of the study information 2018/10/01
Last modified on 2018/09/08

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Basic information
Public title The efficacy of interval walking training in rehabilitation medicine for mild heart failure patients
Acronym Application of interval walking training to rehabilitation medicine for mild heart failure patients
Scientific Title The efficacy of interval walking training in rehabilitation medicine for mild heart failure patients
Scientific Title:Acronym Application of interval walking training to rehabilitation medicine for mild heart failure patients
Region
Japan

Condition
Condition Mild heart failure
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy and safety of interval walking training in rehabilitation medicine for mild heart failure patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Peak aerobic capacity
Key secondary outcomes Peak heart rate
Ventiation threshold
Oxygen puslse (O2 pulse)
Left ventricular diastolic capacity (E/e')
Left ventricular ejection fraction(LVEF)
B type Na uretic peptide(BNP)

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 Cycling exercise training (30min/day, a day/ week)at the intensity above the anaerobic threshold
Interventions/Control_2 Cycling exercise training (30min/day, a day/ week) + Interval walking training (30min/day, 3days/ week) above the anaerobic threshold
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
40 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients who had not increased peak aerobic capacity although they had undergone cycling exerice training 30min/day, a day/ week, for more than 6 months in a hospital.
2) Patients who are classified into level I or II according to the NYHA classification.
3) Patients in whom the left ventricular ejection fraction is less than 60%.
4) Patients in whom plasma Na uretic peptide concentration is more than 18.5 pg/ml.
5) Patients who give an informed consent to voluantarily particopate in the study.
Key exclusion criteria 1) Patients who are classified into the level II or III according to the NYHA classification.
2) Patients whose left ventricular ejection fraction is more than 60% and plasma Na uretic peptide is lower than 18.5pg/ml.
3)Patients whom a primary investigator and/or a cardiologist judge as irrerevant to participate in the study.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shizue Masuki
Organization Shinshu University
Division name Graduate School of Medicine
Zip code
Address 3-1-1 Asahi Matsumoto
TEL 0263-37-2682
Email masuki@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Nose
Organization Shinshu University
Division name Graduate School of Medicine
Zip code
Address 3-1-1 Asahi Matsumoto
TEL 0263-37-2681
Homepage URL
Email nosehir@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Ministry of Education, Cuture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor North Alps Medical Center Azumi Hospital
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
2018 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
2018 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 01 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
2018 Year 09 Month 08 Day
Last modified on
2018 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038832

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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