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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035866
Receipt No. R000040859
Scientific Title Effect of hand-grip exercise on home blood pressure measurements in hypertensive patients
Date of disclosure of the study information 2019/02/13
Last modified on 2019/02/13

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Basic information
Public title Effect of hand-grip exercise on home blood pressure measurements in hypertensive patients
Acronym Effect of hand-grip exercise on home blood pressure measurements in hypertensive patients
Scientific Title Effect of hand-grip exercise on home blood pressure measurements in hypertensive patients
Scientific Title:Acronym Effect of hand-grip exercise on home blood pressure measurements in hypertensive patients
Region
Japan

Condition
Condition hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of hand-grip exercise on home blood pressure measurements in hypertensive patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes home blood pressure, 2 months, 4 months after intervention
Key secondary outcomes handgrip strength, body composition, bone density, brachial-ankle pulse wave velocity(baPWV), type A behavior pattern, Self-Rating Questionnaire For Depression(SRQ-D)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 group A: hand-grip training(2 months), non training control(2 months)
Interventions/Control_2 group B: non training control(2 months), hand-grip training(2 months)
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
28 years-old <=
Age-upper limit
81 years-old >=
Gender Male and Female
Key inclusion criteria hypertensive patiens: mean of 5 days morning home BPs of 135mmHg or over for systolic and 85mmHg or over for diastolic
Key exclusion criteria 1)BPs of 180mmHg or over for systolic and 110mmHg or over for diastolic
2)cerebro-or cardiovascular events during recent 6 months
3)chronic kidney disease stage of below G3a
4)under cancer treatment
5)under formone replacement therapy
Target sample size 54

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name masanori munakata
Organization Research Center for the Promotion of Health and Employment Supports, Tohoku Rosai Hospital
Division name Section of preventive medicine
Zip code
Address 3-21, Dainohara 4, Aoba-ku, Sendai-City, 981-8563, Japan
TEL 0222751085
Email munakata@tohokuh.johas.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name masanori munakata
Organization Research Center for the Promotion of Health and Employment Supports, Tohoku Rosai Hospital
Division name Section of preventive medicine
Zip code
Address 3-21, Dainohara 4, Aoba-ku, Sendai-City, 981-8563, Japan
TEL 0222751085
Homepage URL
Email munakata@tohokuh.johas.go.jp

Sponsor
Institute Research Center for the Promotion of Health and Employment Supports, Tohoku Rosai Hospital
Institute
Department

Funding Source
Organization Japan Organization of Occupational Health and Safety
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Aomori Rosai Hospital
Fukushima Rosai Hospital
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
2019 Year 02 Month 13 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 Completed
Date of protocol fixation
2016 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 20 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
2019 Year 02 Month 13 Day
Last modified on
2019 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040859

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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