UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035385 |
|---|---|
| Receipt number | 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 19:08:25 |
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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
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
naokifujimo@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040319
