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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027265
Receipt No. R000030156
Scientific Title Effects of Isometric Handgrip Training on Blood Pressure in Patients with Heart Failure
Date of disclosure of the study information 2017/05/08
Last modified on 2018/05/09

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Basic information
Public title Effects of Isometric Handgrip Training on Blood Pressure in Patients with Heart Failure
Acronym HANDGRIP-HF
Scientific Title Effects of Isometric Handgrip Training on Blood Pressure in Patients with Heart Failure
Scientific Title:Acronym HANDGRIP-HF
Region
Japan

Condition
Condition Heart failure
Classification by specialty
Cardiology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of handgrip training on hemodynamics, exercise capacity and QOL in patients with heart failure with preserved EF(HFpEF).
Basic objectives2 Others
Basic objectives -Others To compare the effects of handgrip training on hemodynamics, exercise capacity and QOL in HFpEF patients and heart failure patients with reduced ejection fraction (HFrEF).
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ambulatory blood pressure after the 3 months of handgrip training
Key secondary outcomes Office blood pressure
Cardiovascular function
6 minutes walk distance
Daily physical activity
Muscle strength
QOL
Blood data

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 3 months of isometric handgrip exercise at 30% MVC(maximal voluntary contraction)for 2 minutes,4 times/day, 3 times/week.
Interventions/Control_2 Contorol patients with no handgrip training
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. Heart failure due to LV dysfunction
2. NYHA functional class I to III
Key exclusion criteria 1. Systolic BP > 180mmHg
2. Additional antihypertensive medication
3. Severe valvular heart disease
4. ACS
5. Cardiogenic shock
6. Systolic BP after handgrip > 250mmHg
7. Pulmonary arterial hypertension and/or hypoxemia due to lung disease
8. Connective tissue disease
9. End-stage renal failure
10. Active inflammation
11. Short life expectancy due to malignancy
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 Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization This work was supported by Grant-in-Aid for Scientific Research(C)
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2017 Year 05 Month 08 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
2016 Year 11 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 08 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
2017 Year 05 Month 08 Day
Last modified on
2018 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030156

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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