UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051251 |
|---|---|
| Receipt number | R000058446 |
| Scientific Title | Randomized controlled trial evaluating retention rates and effectiveness of dance videos in hypertensive patients. |
| Date of disclosure of the study information | 2023/06/03 |
| Last modified on | 2023/06/03 13:55:57 |
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Basic information
Public title
Randomized controlled trial evaluating retention rates and effectiveness of dance videos in hypertensive patients.
Acronym
Randomized controlled trial evaluating the effects of dance videos on hypertensive patients.
Scientific Title
Randomized controlled trial evaluating retention rates and effectiveness of dance videos in hypertensive patients.
Scientific Title:Acronym
Randomized controlled trial evaluating the effects of dance videos on hypertensive patients.
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients suffering from hypertension have not had any specific exercise regimen. In recent years, dance has been made a compulsory part of classes in Japan, and we thought it could be a tool for continued exercise. Therefore, the purpose of this study is to evaluate how much blood pressure and body composition change after watching a self-made dance video and actually performing the movements.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure in the exam room, dance video viewing retention, well-being, body composition measurements, time to achieve MVPA, Numerical Rating Scale (NRS) for back pain and stiff shoulders, and sleep quality.
Key secondary outcomes
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise therapy using dance videos Five dance videos with exercise intensities of 5-7 metabolic equivalents (METs) were created. They may use any of the videos, but instructed that the five videos should be performed for 70 minutes per week. This would be a total of 2 months of intervention. Tell them to watch the videos once a day if possible. Regardless of intervention or non-intervention, the participants will be asked to wear an accelerometer (wGT3X-BT monitor/Acti Japan) for 2 weeks before and 6 weeks after the intervention, and the amount of physical activity will be evaluated by picking 4 days during the 2 weeks when the wearing time exceeds 10 hours or more.
Interventions/Control_2
Control group
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with hypertension who are attending Juntendo University Hospital for General Medicine only and meet the following criteria
(1) Patients with hypertension who are attending Juntendo University Hospital for General Medicine only.
(2) Patients who have received a full explanation of their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the study.
Key exclusion criteria
Exclusion Criteria
(1) Patients with cardiac disease and other conditions for which a physician has ordered exercise restrictions
(2) Those with dyspnea on light exertion after medical interview
(3) Patients who cannot balance on one leg
(4) Those who newly started or were added to existing medications for lifestyle-related diseases (hypertension, dyslipidemia, diabetes mellitus, hyperuricemia) after the start of the intervention.
(5) Those for whom the principal investigator and principal study author(s) determine that discontinuation of the study is appropriate for other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Taiju |
| Middle name | |
| Last name | Miyagami |
Organization
Juntendo University Faculty of Medicine
Division name
Department of General Medicine
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-Ku, Tokyo, Japan
TEL
08050657077
tmiyaga@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Miyagami |
| Middle name | |
| Last name | Taiju |
Organization
Juntendo University Faculty of Medicine
Division name
Department of General Medicine
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-Ku, Tokyo, Japan
TEL
08050657077
Homepage URL
miya0829gami@gmail.com
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Faculty of Medicine, Department of Medicine, Soon Chun University
Address
2-1-1, Hongo, Bunkyo-Ku, Tokyo, Japan
Tel
08050657077
tmiyaga@juntendo.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
| 2023 | Year | 06 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2023 | Year | 06 | Month | 03 | Day |
Last modified on
| 2023 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058446
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