UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036374 |
|---|---|
| Receipt number | R000041131 |
| 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 |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2020/04/01 09:06:28 |
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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
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
kkario@jichi.ac.jp
Sponsor or person
Institute
Jichi medical university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041131
