UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027265 |
|---|---|
| Receipt number | 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 11:28:26 |
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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
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
Mie University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030156
