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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033238
Receipt No. R000037852
Scientific Title Effects of smoking cessation on the progression of arterial stiffness in postmenopausal women
Date of disclosure of the study information 2018/07/06
Last modified on 2021/01/04

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Basic information
Public title Effects of smoking cessation on the progression of arterial stiffness in postmenopausal women
Acronym Effects of smoking cessation on the progression of arterial stiffness in postmenopausal women
Scientific Title Effects of smoking cessation on the progression of arterial stiffness in postmenopausal women
Scientific Title:Acronym Effects of smoking cessation on the progression of arterial stiffness in postmenopausal women
Region
Japan

Condition
Condition arterial stiffness
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of smoking cessation on the progression of arterial stiffness in postmenopausal women.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes brachial-ankle pulse wave velocity, 6 months, 12 months, 24 months after intervention
Key secondary outcomes clinic blood pressure, home blood pressure, body composition, bone density, carbon monoxide

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 Smoking cessation guidance(6 months), measurement(24 months)
Interventions/Control_2 Measurement only(24 months)
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
40 years-old <=
Age-upper limit
60 years-old >=
Gender Female
Key inclusion criteria Postmenopausal women
Current smoker
Key exclusion criteria Outpatients visiting a clinin for smoking cessation
Use anti-smoking drug
Target sample size 20

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 Preventive medicine section
Zip code 981-8563
Address 3-21, Dainohara 4, Aoba-ku, Sendai-City, 981-8563, Japan
TEL +81-22-275-1111
Email 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 Preventive medicine section
Zip code 981-8563
Address 3-21, Dainohara 4, Aoba-ku, Sendai-City, 981-8563, Japan
TEL +81-22-275-1111
Homepage URL
Email munakata@tohokuh.johas.go.jp

Sponsor
Institute Research Center for the Promotion of Health and Employment Supports, Tohoku Rosai Hospital
Institute
Department

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 Research Center for the Promotion of Health and Employment Supports, Tohoku Rosai Hospital
Address 3-21, Dainohara 4, Aoba-ku, Sendai-City, 981-8563, Japan
Tel +81-22-275-1111
Email utsumi@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
2018 Year 07 Month 06 Day

Related information
URL releasing protocol https://www.tohokuh.johas.go.jp/others/prevention/gyoseki/img/seika_03.pdf
Publication of results Unpublished

Result
URL related to results and publications https://www.tohokuh.johas.go.jp/others/prevention/gyoseki/img/seika_03.pdf
Number of participants that the trial has enrolled 16
Results In the intervention group, the number of smoking cigarettes tended to decrease, and both the exhaled carbon monoxide concentration and casual systolic blood pressure were decreased significantly while brachial-ankle remained unchanged. Only one person achieved smoking cessation. Stress at workplace or home and menopause-related symptoms were suggested as factors to obstruct smoking cessation. None of the measured unchanged in the control group.
Results date posted
2021 Year 01 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics The 16 participants were 56.5 (6.7) years old.
Of the subjects analyzed, 6 in the intervention group were 54.7 (4.0) years and 6 in the control group were 58.3 (8.6) years.
Participant flow Eight subjects were equally assigned to both groups but 2 subjects were drop-out from each group.
Adverse events nothing
Outcome measures 1.Number of cigarettes smoked
Intervention group: 20.0 (13.3, 23.8), 10.0 (4.5, 20.0) after 6 months
Control group: 17.5 (5.8, 20.0), 17.5 (5.8, 20.0) after 6 months
*Data is median (25th, 75th)
2.Carbon monoxide concentration in exhaled breath (ppm)
Intervention group: 25.3 (20.6), 12.8 (14.8) after 6 months
Control group: 14.7 (9.0), 13.8 (11.1) after 6 months
3.Systolic blood pressure (mmHg)
Intervention group: 121.5 (17.3), 106.7 (15.0) after 6 months
Control group: 113.3 (12.2), 114.2 (9.0) after 6 months
*Data is average (SD)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 12 Month 01 Day
Date of IRB
2015 Year 01 Month 09 Day
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2019 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 02 Day
Last modified on
2021 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037852

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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