UMIN-CTR Clinical Trial

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
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)

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040292