UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056306 |
|---|---|
| Receipt number | R000064224 |
| Scientific Title | Effects of different exercise modes on hemodynamics and physical function in middle-age or older hypertensive patients: A randomized controlled trial |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2024/11/27 16:52:32 |
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Basic information
Public title
Effects of different exercise modes on hemodynamics and physical function in middle-age or older hypertensive patients
Acronym
Effects of different exercise modes on hemodynamics and physical function in middle-age or older hypertensive patients
Scientific Title
Effects of different exercise modes on hemodynamics and physical function in middle-age or older hypertensive patients: A randomized controlled trial
Scientific Title:Acronym
Effects of different exercise modes on hemodynamics and physical function in middle-age or older hypertensive patients: A randomized controlled trial
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of combined training (aerobic exercise + resistance training) and resistance training alone on hemodynamics and physical function in middle-aged and older hypertensive patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in clinic blood pressure before and after 24-weeks exercise training.
Key secondary outcomes
･Brachial-ankle pulse wave velocity (baPWV)
･Glucose and lipid levels
･Body composition
･Grip strength
･Time for ten-repetition sit-to-stand test (SS-10)
･Time for single leg standing (SLS)
･Knee extension strength (KES)
･Foot dorsal flexer strength (FDFS)
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
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
･Combined training group perform aerobic exercise and resistance training for 6 months.
Interventions/Control_2
･Resistance training group perform resistance training for 6 months.
Interventions/Control_3
Control group live a usual life without any exercise intervensions practice for 6 months.
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
| 55 | years-old | <= |
Age-upper limit
| 88 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
･Age 55 or older.
･Outpatients whose clinic blood pressure is 130mmHg or higher for systolic or 80mmHg or higher for diastolic, and are independent in daily living activities.
Key exclusion criteria
･Those whose clinic blood pressure is 180mmHg or over for systolic and 110mmHg or over for diastolic.
･Those who have developed cerebrovascular or cardiovascular disease within the past 6 months.
･Those who receive anti-cancer drug or hormonal therapy.
Target sample size
90
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 | 12 | 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
90
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 | 07 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2024 | 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 | 11 | Month | 29 | Day |
Last modified on
| 2024 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064224
