UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of isometric handgrip exercise on hemodynamics and left ventricular function
Title of the study (Brief title)	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	Naoki Fujimoto MD, PhD
Organization	Mie University Graduate School of Medicine
Division name	Department of Cardiology and Nephrology
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	Naoki Fujimoto MD, PhD
Organization	Mie University Graduate School of Medicine
Division name	Department of Cardiology and Nephrology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 04 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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