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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004623
Receipt No. R000005512
Scientific Title Randomized controlled trial about the influence of instruction to use programmed room heating on morning blood pressure surge.
Date of disclosure of the study information 2010/11/25
Last modified on 2015/12/25

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Basic information
Public title Randomized controlled trial about the influence of instruction to use programmed room heating on morning blood pressure surge.
Acronym Randomized controlled trial about the influence of instruction to use programmed room heating on morning blood pressure surge.
Scientific Title Randomized controlled trial about the influence of instruction to use programmed room heating on morning blood pressure surge.
Scientific Title:Acronym Randomized controlled trial about the influence of instruction to use programmed room heating on morning blood pressure surge.
Region
Japan

Condition
Condition none
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the suppressive effect of instruction to set programmed room heating on morning blood pressure surge.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Sleep-trough Morning Blood Pressure Surge: 1) minus 2)
1) Morning BP: average in 2 hours after wake-up time,
2) Lowest sleeping BP: average of three BP readings centered on the lowest sleeping BP.
Key secondary outcomes Blood pressure in 30 minutes after awaking, mean blood pressure in 60 minutes after awaking, pulse rate, pulse pressure.
Ambulatory blood pressure, indoor temperature, and physical activity in 4h after rising.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Instruction to set the heater of living room to start automatically at 60 minutes before awaking time in winter morning (if possible target temperature is 24 degree centigrade)
Interventions/Control_2 control: without any instruction
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Male and female aged 60 and above
Key exclusion criteria Participants who have no heating devises with programmed starting function, participants who habitualy use the living room as a bed room.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name KEIGO SAEKI
Organization Nara Medical University School of Medicine
Division name Department of Community health and epidemiology
Zip code
Address 840 Shijo-cho, Kashihara-shi, Nara, Japan
TEL 0744-22-3051
Email saekik@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name KEIGO SAEKI
Organization Nara Medical University School of Medicine
Division name Department of Community health and epidemiology
Zip code
Address 840 Shijo-cho, Kashihara-shi, Nara, Japan
TEL 0744-22-3051
Homepage URL
Email saekik@naramed-u.ac.jp

Sponsor
Institute Department of community health and epidemiology, Nara Medical University School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2010 Year 11 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Intervention significantly increased living room temperature by (2.09&ordm;C, 95%CI: 1.28 to 2.9), and significantly decreased SBP and DBP by 4.43/2.33 during 4h after rising. J Hypertens. 2015, 33(11), 2338-43
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
2010 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2014 Year 01 Month 31 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
2014 Year 05 Month 31 Day
Date analysis concluded
2014 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 11 Month 25 Day
Last modified on
2015 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005512

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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