UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063599 |
|---|---|
| Receipt number | R000072785 |
| Scientific Title | Comparison of Cardiovascular Recovery, Cognitive Performance, and Quality of Life Among Never-Smokers, Exclusive Electronic Cigarette Users, Exclusive Conventional Cigarette Smokers, and Dual Users: A Comparative Cross-Sectional Observational Study |
| Date of disclosure of the study information | 2026/11/11 |
| Last modified on | 2026/11/11 22:55:31 |
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Basic information
Public title
GENC YETISKINLERDE ELEKTRONIK SIGARA, GELENEKSEL SIGARA VE IKILI KULLANIMA GORE KARDIYOVASKULER TOPARLANMA, BILISSEL PERFORMANS VE YASAM KALITESININ KARSILASTIRILMASI
Acronym
EC-CVQoL
Scientific Title
Comparison of Cardiovascular Recovery, Cognitive Performance, and Quality of Life Among Never-Smokers, Exclusive Electronic Cigarette Users, Exclusive Conventional Cigarette Smokers, and Dual Users: A Comparative Cross-Sectional Observational Study
Scientific Title:Acronym
SMOKE-OBS
Region
| Asia(except Japan) |
Condition
Condition
Electronic cigarette use, conventional cigarette smoking, and dual use among young adults.
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this cross-sectional observational study is to compare post-exercise heart rate recovery, cardiorespiratory fitness, cognitive performance, health-related quality of life, sleep quality, respiratory symptoms, and physical activity levels among young adults aged 18-35 years who have never smoked, exclusively smoke conventional cigarettes, exclusively use electronic cigarettes, or use both products dual users. Heart rate recovery at the first and third minutes following exercise, estimated maximal oxygen consumption (VO2max), and cognitive performance parameters related to selective attention and interference control will be assessed. Additionally, the study aims to investigate associations between smoking and vaping characteristics and these health-related outcomes, taking into account physical activity levels and relevant individual factors.
Basic objectives2
Others
Basic objectives -Others
Comparison of cardiovascular recovery, cardiorespiratory fitness, cognitive performance, quality of life, sleep quality, respiratory symptoms, and physical activity across different smoking and vaping exposure groups.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Post-exercise heart rate recovery (HRR) at the first and third minutes following exercise (HRR1 and HRR3), calculated as the difference between peak exercise heart rate and heart rate measured at 1 and 3 minutes during recovery, respectively. Measurements will be performed during a single assessment session in this cross-sectional observational study.
Key secondary outcomes
Cardiorespiratory fitness, assessed by estimated maximal oxygen consumption (VO2max, mL/kg/min).
Cognitive performance, assessed through selective attention and interference control using cognitive test performance scores.
Health-related quality of life, assessed using standardized questionnaire scores.
Sleep quality, assessed using standardized sleep quality questionnaire scores.
Respiratory symptoms, assessed using a standardized respiratory symptom questionnaire.
Physical activity level, assessed using a standardized physical activity questionnaire.
Associations between conventional cigarette smoking and electronic cigarette use characteristics and the assessed health-related outcomes, considering physical activity levels and relevant individual factors.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Adults aged 18-35 years.
2. Ability to understand and complete the study assessments.
3. Physical ability to safely perform the three-minute step test.
4. Voluntary participation and provision of written informed consent.
5. Eligibility for one of the following groups:
Group 1: Individuals with no history of regular conventional or electronic cigarette use and no current use of tobacco or nicotine products.Group 2: Individuals who have regularly smoked conventional cigarettes for at least six months, currently continue smoking, and do not currently use electronic cigarettes or other tobacco or nicotine products.Group 3: Individuals who have regularly used electronic cigarettes for at least six months, currently continue vaping, and do not currently use conventional cigarettes or other tobacco or nicotine products.Group 4: Individuals who have used both conventional and electronic cigarettes for at least six months, currently continue using both products, and do not currently use other tobacco or nicotine products.
Key exclusion criteria
1. Diagnosed cardiovascular or pulmonary diseases that may affect exercise responses.
2. Regular use of medications affecting heart rate or autonomic cardiovascular responses, such as beta-blockers or certain antiarrhythmic drugs.
3. Neurological or psychiatric disorders that may substantially affect cognitive performance.
4. Acute respiratory infection, febrile illness, or other acute health conditions at the time of assessment.
5. Musculoskeletal disorders, balance impairments, or movement limitations preventing safe performance of the three-minute step test.
6. Being under the influence of alcohol or other psychoactive substances, or having a substance-related condition that may compromise assessment safety or test performance.
7. Any clinical contraindication to exercise testing.
8. Pregnancy.
Target sample size
92
Research contact person
Name of lead principal investigator
| 1st name | Manolya |
| Middle name | |
| Last name | acar |
Organization
Baskent University
Division name
Department of Physiotherapy and Rehabilitation
Zip code
06790
Address
Baskent university Department of Physiotherapy and Rehabilitation
TEL
+905392699266
acarmanolya@hotmail.com
Public contact
Name of contact person
| 1st name | Manolya |
| Middle name | |
| Last name | acar |
Organization
Baskent University
Division name
Department of Physiotherapy and Rehabilitation
Zip code
06790
Address
Baskent University, Health Sicence Faculty, Department of Physiotherapy and Rehabilitation
TEL
+905392699266
Homepage URL
acarmanolya@hotmail.com
Sponsor or person
Institute
Baskent Univeristy
Institute
Department
Personal name
Funding Source
Organization
Baskent University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
turkey
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Baskent University
Address
Baskent University, Baglica Campus, Faculty of Health Sciences.
Tel
+905392699266
ardenmanolya@gmail.com
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
| 2026 | Year | 11 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
his study is designed as a cross-sectional, observational, comparative study involving young adults aged 18-35 years. Participants will be classified into four groups according to their existing smoking and vaping habits: never-smokers, exclusive conventional cigarette smokers, exclusive electronic cigarette users, and dual users of conventional and electronic cigarettes. No smoking or vaping exposure will be assigned or administered by the researchers, and no therapeutic intervention or randomization will be performed.
All participants will undergo a single assessment session. Post-exercise heart rate recovery at 1 and 3 minutes and cardiorespiratory fitness will be evaluated using a three-minute step test. Cognitive performance, including selective attention and interference control, will be assessed using the Eriksen Flanker Test. Health-related quality of life, sleep quality, respiratory symptoms, and physical activity levels will be assessed using standardized questionnaires.
Between-group comparisons and associations between smoking and vaping characteristics and health-related outcomes will be examined, considering relevant individual factors and physical activity levels. The study aims to investigate associations rather than establish causal relationships.
Management information
Registered date
| 2026 | Year | 11 | Month | 11 | Day |
Last modified on
| 2026 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072785
