UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035408
Receipt number R000040292
Scientific Title The Effectiveness of Handgrip exercise in Hypertension
Date of disclosure of the study information 2019/01/01
Last modified on 2020/07/07 22:11:00

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Basic information

Public title

The Effectiveness of Handgrip exercise in Hypertension

Acronym

The Effectiveness of Handgrip exercise in Hypertension

Scientific Title

The Effectiveness of Handgrip exercise in Hypertension

Scientific Title:Acronym

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

1st name Tadao
Middle name
Last name Okada

Organization

Kameda Family Clinic at Tateyama

Division name

Family Medicine

Zip code

294-0051

Address

4304-9 Masaki, Tateyama-shi, Chiba

TEL

0470-20-5520

Email

office.kfct@gmail.com


Public contact

Name of contact person

1st name Akihiro
Middle name
Last name Ito

Organization

Kameda Family Clinic at Tateyama

Division name

Family Medicine

Zip code

294-0051

Address

4304-9 Masaki, Tateyama-shi, Chiba

TEL

0470-20-5520

Homepage URL


Email

office.kfct@gmail.com


Sponsor or person

Institute

Medical Corporation Tesshokai

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization

Medical Corporation Tesshokai IRB

Address

929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan 296-8602

Tel

04-7092-2211

Email

clinical_research@kameda.jp


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


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

2018 Year 10 Month 19 Day

Date of IRB

2018 Year 12 Month 13 Day

Anticipated trial start date

2019 Year 01 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

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 29 Day

Last modified on

2020 Year 07 Month 07 Day



Link to view the page

Value
https://center6.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