UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053328 |
|---|---|
| Receipt number | R000060572 |
| Scientific Title | Effects of low intensity isometric handgrip training on blood pressure, glucose and lipid metabolism in hypertensive patients: a randomized controlled trials. |
| Date of disclosure of the study information | 2024/01/11 |
| Last modified on | 2024/01/09 15:52:59 |
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Basic information
Public title
Effects of low intensity isometric handgrip training on blood pressure, glucose and lipid metabolism in hypertensive patients.
Acronym
Effects of low intensity isometric handgrip training on blood pressure, glucose and lipid metabolism in hypertensive patients.
Scientific Title
Effects of low intensity isometric handgrip training on blood pressure, glucose and lipid metabolism in hypertensive patients: a randomized controlled trials.
Scientific Title:Acronym
Effects of low intensity isometric handgrip training on blood pressure, glucose and lipid metabolism in hypertensive patients: a randomized controlled trials.
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of low intensity (15% MVC) isometric handgrip (IHG) training on blood pressure levels in hypertensive patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in home blood pressure after 12-weeks low intensity IHG
Key secondary outcomes
･Clinic blood pressure
･Brachial-ankle pulse wave velocity (baPWV)
･Glucose and lipid metabolism indicators
･Body composition
･Grip strength
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
･Study period is 6 months
･Intervention group perform low intensity IHG for the former half of 12 weeks but not in the latter half of 12 weeks.
Interventions/Control_2
･Study period is 6 months
･Control group do not perform any IHG during the study period.
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
| 41 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet any of the following eligibility criteria
･Five-days mean of morning BP at home is >= 125mmHg for systolic and/or >= 75mmHg for diastolic.
･Clinic BP is >= 130mmHg for systolic and/or >= 80mmHg for diastolic.
Key exclusion criteria
1. Clinic SBP >= 160mmHg and/or clinic DBP >= 100mmHg
2. History of cerebrovascular or cardiovascular events within the previous 6 months
3. Chronic kidney disease of stage G3b or lower
4. Ongoing cancer treatment with chemotherapy
5. Ongoing hormone replacement therapy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Munakata |
Organization
Research Center for the Promotion of Health and Employment Supports, Tohoku Rosai Hospital
Division name
Section of preventive medicine
Zip code
981-8563
Address
3-21, Dainohara 4, Aoba-ku, Sendai-City, 981-8563, Japan
TEL
022-275-1085
munakata@tohokuh.johas.go.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Munakata |
Organization
Research Center for the Promotion of Health and Employment Supports, Tohoku Rosai Hospital
Division name
Section of preventive medicine
Zip code
981-8563
Address
3-21, Dainohara 4, Aoba-ku, Sendai-City, 981-8563, Japan
TEL
022-275-1085
Homepage URL
munakata@tohokuh.johas.go.jp
Sponsor or person
Institute
Research Center for the Promotion of Health and Employment Supports, Tohoku Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Organization of Occupational Health and Safety
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The institutional review board of Tohoku Rosai Hospital
Address
3-21, Dainohara 4, Aoba-ku, Sendai-City, 981-8563, Japan
Tel
022-275-1085
munakata@tohokuh.johas.go.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
| 2024 | Year | 01 | Month | 11 | 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
60
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
| 2020 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2023 | 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
| 2024 | Year | 01 | Month | 11 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060572
