UMIN-CTR Clinical Trial

Basic information
Public title	Effects of aerobic exercise and hand grip exercise on blood pressure using a new multisensor 24-hour ambulatory blood pressure monitoring system for patients with hypertension
Acronym	Effects of aerobic exercise and hand grip exercise on blood pressure for patients with hypertension
Scientific Title	Effects of aerobic exercise and hand grip exercise on blood pressure using a new multisensor 24-hour ambulatory blood pressure monitoring system for patients with hypertension
Scientific Title:Acronym	Effects of aerobic exercise and hand grip exercise on blood pressure for patients with hypertension
Region	Japan

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

Objectives
Narrative objectives1	We examine the antihypertensive effects of aerobic and handgrip exercise therapy in hypertensive patients, focusing on physical activity and blood pressure variability,by using a portable automatic sphygmomanometer "TM-2441" equipped with multiple sensors.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Whether there is a difference in blood pressure variability with respect to physical activity that can be evaluated by the multi-sensor-equipped ABPM by performing aerobic exercise intervention by walking in hypertensive patients with low daily activities.
Key secondary outcomes	1) Whether there is a difference in blood pressure variability with respect to physical activity that can be evaluated by the multi-sensor-equipped ABPM by performing a walking intervention in hypertensive patients whose daily activity is low 2) Whether there is a difference in blood pressure variability in ABPM by performing handgrip exercise in hypertensive patients 3) Whether there is a difference between daily activity and blood pressure variability in ABPM in hypertensive patients 4) Whether the parameters such as blood test, echocardiography, baPWV change by intervention of walking in hypertensive patients whose activity level in daily life is low

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
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	Patients were put on a pedometer for 4 weeks, and the results were divided into two groups, an exercise habit group of over 7000 steps/day and a non-exercise habit group of under 7000 steps/day.In the exercise habit group, the patient continues only the handgrip exercise for 12 weeks, and in the non-exercise habit group, the walking is continued for 12 weeks in addition to the handgrip exercise. 1)Handgrip exercise Based on the guidelines of AHA 2017, patients will receive 2 minutes x 4 times (with a 1-minute break between them) three times a week with a force of 30% of maximum grip.At the time of implementation at home, hand towel will be rolled and held in place, and will be given guidance in advance.The patient records in the journal the day on which the handgrip exercise was performed.
Interventions/Control_2	2)Walking In the non-exercise habit group, the patient lives with a pedometer, walks for over 10000 steps/day and continues for 12 weeks.Patients should walk at their own pace, regardless of exercise intensity.
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients with hypertension taking one or more antihypertensive drugs 2)Patients going to the clinic 3)Men and woman over 20
Key exclusion criteria	1)Patients with a history of ischemic heart disease or valvular disease 2)Patients with urine protein(+) or BP over 180/100mmHg 3)Highly obese patients with BMI over 30 4)Diabetic patients with fasting blood glucose over 250mg/dL, urinary ketone body(+) and diabetic retinopathy 5)Patients with ECG abnormalities suggestive of myocardial ischemia 6)Patients for whom it was determined that a safe intervention was difficult
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kazuomi Middle name Last name Kario
Organization	Jichi medical university
Division name	Cardiology internal medicine
Zip code	329-0498
Address	3311-1, Yakushiji, Shimotsuke Shi, Tochigi Ken
TEL	0285-58-7344
Email	kkario@jichi.ac.jp

Public contact
Name of contact person	1st name Kazuomi Middle name Last name Kario
Organization	Jichi medical university
Division name	Cardiology internal medicine
Zip code	329-0498
Address	3311-1, Yakushiji, Shimotsuke Shi, Tochigi Ken
TEL	0285-58-7344
Homepage URL
Email	kkario@jichi.ac.jp

Sponsor
Institute	Jichi medical university
Institute
Department

Funding Source
Organization	Japan Association for Development of Community Medicine
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Jichi medical university
Address	3311-1, Yakushiji, Shimotsuke Shi, Tochigi Ken
Tel	0285-58-8933
Email	rinri@jichi.ac.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

Other administrative information
Date of disclosure of the study information	2019 Year 04 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 11 Day
Date of IRB	2019 Year 01 Month 15 Day
Anticipated trial start date	2019 Year 03 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 04 Month 01 Day
Last modified on	2020 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041131