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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035385
Receipt No. R000040319
Scientific Title Effects of isometric handgrip exercise on hemodynamics and left ventricular function
Date of disclosure of the study information 2018/12/27
Last modified on 2018/12/27

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Basic information
Public title Effects of isometric handgrip exercise on hemodynamics and left ventricular function
Acronym Handgrip exercise study
Scientific Title Effects of isometric handgrip exercise on hemodynamics and left ventricular function
Scientific Title:Acronym Handgrip exercise study
Region
Japan

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

Objectives
Narrative objectives1 To evaluate hemodynamics and left ventricular function at 30% of maximal voluntary contraction during 3 minutes of isometric handgrip exercise and 3 minutes of post-exercise circulatory arrest in heart failure with and without preserved ejection fraction.
Basic objectives2 Others
Basic objectives -Others To evaluate the impact of mechanoreflex and metaboreflex on hemodynamics in heart failure.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood pressure, left ventricular enddiastolic and endsystolic pressure, and heart rate during isometric handgrip exercise and postexercise circulatory arrest.
Key secondary outcomes Left ventricular systolic and diastolic function, left ventricular morphology and function by echocardiogram, muscle strength, right ventricular hemodynamics, six minute walk distance, blood test.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Behavior,custom
Interventions/Control_1 3 minutes of isometric handgrip exercise and 3 minutes of postexercise circulatory arrest
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. no heart failure symptom at supine position.
2. heart failure with reduced ejection fraction (less than 40 percent, n=10), and heart failure with preserved ejcetion fraction (n=10)
Key exclusion criteria 1) unstable AP
2) myocardial infraction with 6 months
3) AF/AFL
4) severe valvular disease
5) Resting SBP>160mmHg or PCWP>25mmHg
6) exercise training > 3times per week
7) percemaker, ICD, CRTD
8) renal dysfunction
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Fujimoto MD, PhD
Organization Mie University Graduate School of Medicine
Division name Department of Cardiology and Nephrology
Zip code
Address 2-174 Edobashi, Tsu 514-8507, Japan
TEL 059-232-1111
Email naokifujimo@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Fujimoto MD, PhD
Organization Mie University Graduate School of Medicine
Division name Department of Cardiology and Nephrology
Zip code
Address 2-174 Edobashi, Tsu 514-8507, Japan
TEL 059-232-1111
Homepage URL
Email naokifujimo@clin.medic.mie-u.ac.jp

Sponsor
Institute Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
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
2018 Year 12 Month 27 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2015 Year 04 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 05 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 12 Month 27 Day
Last modified on
2018 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040319

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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