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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035408
Receipt No. R000040292
Official scientific title of the study The Effectiveness of Handgrip exercise in Hypertension
Date of disclosure of the study information 2019/01/01
Last modified on 2019/01/02

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Basic information
Official scientific title of the study The Effectiveness of Handgrip exercise in Hypertension
Title of the study (Brief title) The Effectiveness of Handgrip exercise in Hypertension
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the effectiveness of hand grip exercise. We conduct double blind random control trial of handgrip exercise in hypertensive patients for 3 months. Then we follow up with both groups for 12 months as a prospective cohort study to see if the effectiveness of their exercise can last long term.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Systolic and diastolic blood pressure at both clinic visit and home at 12 weeks
Key secondary outcomes Home blood pressure at 4,8 weeks and 6,9,12 months. Systolic and Diastolic blood pressure at clinic visit at 6,9,12 months.
compliance of handgrip exercise over 12 weeks
the rate of concordance in 30% handgrip exercise machine and the rate of concordance in placebo machine.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 participants undergo isometric hand grip exercise:four sets of 2-min isometric contractions(using alternate hands) on a programmed handgrip dynamometer(medical grip;Ohashi Chiso Laboratory,Tokyo,Japan)at 30% of maximal voluntary contraction,each separated by a 1-min rest interval.(turning on blue lamp for right grip, yellow lamp for too weak,red for too strong.) Participants will continue exercise for 12 weeks, then we open the label and ask the volunteer if they want to continue the exercise for another 9 months.
Interventions/Control_2 participants undergo isometric hand grip exercise:four sets of 2-min isometric contractions(using alternate hands) on a programmed handgrip dynamometer(medical grip;Ohashi Chiso Laboratory,Tokyo,Japan)at 15% of maximal voluntary contraction,each separated by a 1-min rest interval.(turning on blue lamp for right grip, yellow lamp for too weak,red for too strong.) Participants will continue the exercise for 12 weeks.
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.Diagnosed Hypertension 4 weeks prior to participate the study. Diagnostic criteria is 140/90 mmHg.
2.Holding home blood pressure monitor and able to measure blood pressure at home.
Key exclusion criteria 1.resting SBP is more than 180 mmHg at the beginning.
2.Changed anti-hypertensive medication within 4 weeks.
3.continuous physical training more than 3 times per week more than 4 weeks before the study.
4.History of peripheral vascular disease and Presenting symptoms.
5.History of congestive heart failure and presenting symptoms more than NYHA 2.
6.uncontrolled arrhythmias or presenting symptoms of arrhythmias.
7. History of acute coronary syndrome or cerebral vascular disease within 4 weeks.
8.History of osteoarthritis or any orthotic disease which make participants difficult to perform handgrip exercise.
9.Any history or present illness which primary care doctor decide that participants are unable to perform handgrip exercise.
Target sample size 100

Research contact person
Name of lead principal investigator Okada Tadao,M.D.
Organization Kameda Family Clinic at Tateyama
Division name Family Medicine
Address 4304-9 Masaki, Tateyama-shi, Chiba
TEL 0470-20-5520
Email office.kfct@gmail.com

Public contact
Name of contact person Akihiro Ito,M.D.
Organization Kameda Family Clinic at Tateyama
Division name Family Medicine
Address 4304-9 Masaki, Tateyama-shi, Chiba
TEL 0470-20-5520
Homepage URL
Email office.kfct@gmail.com

Sponsor
Institute Medical Corporation Tesshokai
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
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 医療法人鉄蕉会亀田ファミリークリニック館山

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 01 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 19 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 12 Month 29 Day
Last modified on
2019 Year 01 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040292

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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