Cigarette SmokingNCT04688177

The Association of Cigarette Smoking on Exercise Capacity and Skeletal Muscle Function in Taiwan Adult Smokers

An observational study of Cigarette Smoking, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 20 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Cigarette Smoking
What is being tested?: Body Composition, Heart rate variability and Grip Strength
Type of treatment: Medical device, Lifestyle or therapy programme
How many people: 52 participants
Where: 1 siteTaiwan
Study dates: 3 Dec 2020to 29 Apr 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 55 years
All sexes
Healthy volunteers accepted
Adult

Study population: Subjects will be invited from community in Taipei City

Who may be able to join

male 20 ≤ age ≤ 45 years old
female 20 ≤ age ≤ 55 years old
age and gender-matched non-smokers

Who cannot join

uncontrolled cardiovascular diseases, neurological diseases, musculoskeletal system problems, or systemic diseases that contraindicate the exercise
women in pregnancy or menopausal women
any ongoing medication that has a documented effect on the autonomic nervous system (e.g., tricyclic anti-depressants)
has been diagnosed with autonomic nervous system disorders

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

National Taiwan University, College of Medicine, Department of Physical Therapy
Taipei, Zhongzheng, 100

Other trials in Taiwan

About this study

Background and purpose: Cigarette smoking would post threats to physical health. Even though studies suggested that long-term cigarette smoking would lead to cardiovascular diseases, pulmonary diseases, or even cancer development, the smoking population all around the world was still common. Before progressing into the disease stage, cigarette smokers might have presented decreasing exercise capacity, skeletal muscle function, and cardiac autonomic function as early signs of physiological function decline. The purposes of this study are (1) to investigate the difference in exercise capacity, skeletal muscle function, and cardiac autonomic function between smokers and never smokers, and (2) to test the hypothesis that cigarette smoking is an independent factor associated with exercise capacity.

Methods: This is a cross-sectional observational study. This study will invite 150 participants from community in Taipei City. The body composition will be analyzed by bioelectrical impedance analysis, and resting heart rate variability will be evaluated by the heart rate variability monitor. Besides, grip strength, exhale carbon monoxide concentration, pulmonary function test, respiratory muscle performance will be measured. Moreover, subject will have to fill up the Fagerström Test for Nicotine Dependence and Seven-Day Physical Activity Recall Questionnaire. Last will be the cardiopulmonary exercise testing. Statistical analyses will be performed by statistical software for social sciences (SPSS) statistical package v.21.0 for Windows. (IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp.) Between-group comparisons of exercise capacity, skeletal muscle function and heart rate variability parameters will be performed using independent Student's t-test. Pearson's correlation coefficient will be used to test the correlations between outcome parameters. Stepwise regression analysis will be used to examine the independent association between smoking and exercise capacity after controlling for confounders. The α level will be set at 0.05. The results of this study would provide the early effects of cigarette smoking on physical function, and highlight the importance of early detection and intervention.

Conditions: Cigarette Smoking
Being tested: Body Composition, Heart rate variability, Grip Strength, Exhale Carbon Monoxide Concentration, Pulmonary Function Test
Keywords: cigarette smoking, exercise capacity, skeletal muscle function, heart rate variability
Medical subject headings: Cigarette Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Body CompositionDevice
The subjects should lie in the supine position on a non-conducting surface for 5 min. 4 surface electrodes with cables will be attached to the right hand and ankle of subjects.
Heart rate variabilityDevice
After supine quietly for 20 min, a lead I electrocardiogram will be taken for 5 min.
Grip StrengthDevice
The participants will squeeze the hand dynamometer as hard as possible with the dominant hand. 3 successive measurements will be taken.
Exhale Carbon Monoxide ConcentrationDevice
Subjects in sitting position, performing 1 inspiration, then exhale to carbon monoxide meter.
Pulmonary Function TestDevice
Subjects should be in a sitting position with a nose clip, then perform pulmonary function test. Participants should perform at least 3 acceptable attempts, but no more than 8 attempts in total.
Respiratory Muscle FunctionDevice
Subject will perform both maximal inspiratory pressure and maximal expiratory pressure for 3 times in sitting position with the nose clip.
Fagerström Test for Nicotine DependenceBehavioural
Fagerström Test for Nicotine Dependence Traditional Chinese version will be adopted. It is a 6-item questionnaire that could help quantify the smoking frequency, amounts, and level of dependence.
Seven-Day Physical Activity Recall QuestionnaireBehavioural
Physical activity will be measured by the Chinese Version of the Seven-Day Physical Activity Recall Questionnaire. Participants will need to recall the time (hours) they spent in various leisure activities in the past 7 days.
Cardiopulmonary exercise testingDevice
Bruce protocol as the treadmill evaluation protocol will be adopted for cardiopulmonary exercise testing.

Study groups in NCT04688177
Study group	Role	What they receive
smokers		cigarette smokers male 20 ≤ age ≤ 45 years old female 20 ≤ age ≤ 55 years old Receives: Device: Body Composition; Device: Heart rate variability; Device: Grip Strength; Device: Exhale Carbon Monoxide Concentration; Device: Pulmonary Function Test; Device: Respiratory Muscle Function; Behavioral: Fagerström Test for Nicotine Dependence; Behavioral: Seven-Day Physical Activity Recall Questionnaire; Device: Cardiopulmonary exercise testing
never smokers		age and gender-matched non-smokers Receives: Device: Body Composition; Device: Heart rate variability; Device: Grip Strength; Device: Exhale Carbon Monoxide Concentration; Device: Pulmonary Function Test; Device: Respiratory Muscle Function; Behavioral: Fagerström Test for Nicotine Dependence; Behavioral: Seven-Day Physical Activity Recall Questionnaire; Device: Cardiopulmonary exercise testing

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximal oxygen uptake
Maximal oxygen uptake, VO2max (ml/kg/min), as an indicator of exercise capacity. Cardiopulmonary exercise testing will be used to evaluate the maximal exercise capacity by a computer-controlled breath-by-breath metabolic measurement system (Carefusion Corporation, Yorba Linda, CA, USA) base on the treadmill. Bruce protocol, which is a graded treadmill evaluation protocol will be adopted.
Measured: After finishing all the other measurement. The measurement will be lasted 15 minutes.

Secondary outcomes (10)

Skeletal muscle function
Skeletal muscle function will be assessed by measuring the grip strength of the dominant hand using a hand dynamometer (Jamar, Jackson, MI, USA).
Measured: After finishing heart rate variability and body composition measurement. The measurement will be lasted 5 minutes.
Cardiac autonomic function
Heart rate variability will be measured by HRV monitor (8Z11, Wegene Technology Inc., Taiwan) in this study.
Measured: After body composition measurement. The measurement will be lasted 20 minutes.
Skeletal muscle mass
Skeletal muscle mass (kilogram, kg) will be measured by a bioelectrical impedance analyzer (BIA). (Maltron BioScan 920, Maltron International Ltd., Esgender, UK). The subjects should lie in the supine position on a non-conducting surface for 5 min. Skeletal muscle mass will be calculated by the equation of Janssen and colleagues.
Measured: After collecting basic data of subjects. The measurement will be lasted 5-10 minutes.
Exhale carbon monoxide concentration
Exhale carbon monoxide will be measured by the carbon monoxide meter (CO Check+, MD Diagnostics LTD) for current smoking status evaluation.
Measured: After finishing heart rate variability and body composition measurement. The measurement will be lasted 1-3 minutes.
Forced expiratory volume in one second
Pulmonary function will be measured by a portable MicroLab® Spirometer (CareFusion, Basingstoke, UK). The outcome measure will include: forced expiratory volume in one second (FEV1, unit: liter).
Measured: The pulmonary function measurement will be lasted 15 minutes.
Forced vital capacity
Pulmonary function will be measured by a portable MicroLab® Spirometer (CareFusion, Basingstoke, UK). The outcome measure will include: forced vital capacity (FVC, unit: liter)
Measured: The pulmonary function measurement will be lasted 15 minutes.
FEV1/FVC ratio
Pulmonary function will be measured by a portable MicroLab® Spirometer (CareFusion, Basingstoke, UK). The outcome measure will include: FEV1/FVC ratio, which is useful for detecting possible dysfunction of the respiratory system in clinical practice.
Measured: The pulmonary function measurement will be lasted 15 minutes.
Respiratory muscle function
Maximal inspiratory pressure (PImax, unit: cmH2O) and maximal expiratory pressure (PEmax, unit: cmH2O) will be measured by a respiratory pressure meter, which could represent the respiratory muscle strength.
Measured: After pulmonary function test measurement. The measurement will be lasted 10 minutes.
Level of nicotine dependence
Fagerström Test for Nicotine Dependence (FTND) Traditional Chinese version will be adopted for quantifying the level of nicotine dependence. FTND is a 6-item questionnaire. The minimum value is 0 points and maximum values is 6 points. The higher score represents the greater nicotine dependence.
Measured: After respiratory muscle function measurement. The measurement will be lasted 3-5 minutes.
Seven-day physical activity recall questionnaire
Physical activity will be measured by the Chinese Version of the Seven-Day Physical Activity Recall Questionnaire. Participants will need to recall the time (hours) they spent in various leisure activities in the past 7 days. The energy expenditure (kcal/day) = metabolic equivalents (METs)*time (hour)*body weight (kg)/7 days.
Measured: After respiratory muscle function measurement. The measurement will be lasted 3-5 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Dec 202029 Apr 2021

First posted29 Dec 2020
Study start3 Dec 2020
Primary completion29 Apr 2021
Study completion29 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (57)Papers the sponsor has linked to this study.
Other trials for Cigarette SmokingStudies of the same condition, open and under way.
More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Cross-sectional
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04688177
Sponsor's protocol ID: 202010123RIND
Status last verified: Dec 2020
First submitted: 14 Dec 2020
Last updated: 24 Jan 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Jamal A, Phillips E, Gentzke AS, Homa DM, Babb SD, King BA, Neff LJ. Current Cigarette Smoking Among Adults - United States, 2016. MMWR Morb Mortal Wkly Rep. 2018 Jan 19;67(2):53-59. doi: 10.15585/mmwr.mm6702a1.
PubMed 29346338
Chen YL, Wu SC, Chen YT, Hsiao PC, Yu YH, Ting TT, Chen CY, Tu YK, Huang JH, Yang HJ, Li CY, Strong C, Yen CF, Yen CF, Chen WJ. E-Cigarette Use in a Country With Prevalent Tobacco Smoking: A Population-Based Study in Taiwan. J Epidemiol. 2019 Apr 5;29(4):155-163. doi: 10.2188/jea.JE20170300. Epub 2018 Sep 1.
PubMed 30175730
Yoshida T, Tuder RM. Pathobiology of cigarette smoke-induced chronic obstructive pulmonary disease. Physiol Rev. 2007 Jul;87(3):1047-82. doi: 10.1152/physrev.00048.2006.
PubMed 17615396
Tindle HA, Stevenson Duncan M, Greevy RA, Vasan RS, Kundu S, Massion PP, Freiberg MS. Lifetime Smoking History and Risk of Lung Cancer: Results From the Framingham Heart Study. J Natl Cancer Inst. 2018 Nov 1;110(11):1201-1207. doi: 10.1093/jnci/djy041.
PubMed 29788259
Thun MJ, Carter BD, Feskanich D, Freedman ND, Prentice R, Lopez AD, Hartge P, Gapstur SM. 50-year trends in smoking-related mortality in the United States. N Engl J Med. 2013 Jan 24;368(4):351-64. doi: 10.1056/NEJMsa1211127.
PubMed 23343064
Teo KK, Ounpuu S, Hawken S, Pandey MR, Valentin V, Hunt D, Diaz R, Rashed W, Freeman R, Jiang L, Zhang X, Yusuf S; INTERHEART Study Investigators. Tobacco use and risk of myocardial infarction in 52 countries in the INTERHEART study: a case-control study. Lancet. 2006 Aug 19;368(9536):647-58. doi: 10.1016/S0140-6736(06)69249-0.
PubMed 16920470
Watson M, Dardari Z, Kianoush S, Hall ME, DeFilippis AP, Keith RJ, Benjamin EJ, Rodriguez CJ, Bhatnagar A, Lima JA, Butler J, Blaha MJ, Rifai MA. Relation Between Cigarette Smoking and Heart Failure (from the Multiethnic Study of Atherosclerosis). Am J Cardiol. 2019 Jun 15;123(12):1972-1977. doi: 10.1016/j.amjcard.2019.03.015. Epub 2019 Mar 18.
PubMed 30967285
Doll R, Peto R, Boreham J, Sutherland I. Mortality in relation to smoking: 50 years' observations on male British doctors. BMJ. 2004 Jun 26;328(7455):1519. doi: 10.1136/bmj.38142.554479.AE. Epub 2004 Jun 22.
PubMed 15213107
Furlanetto KC, Mantoani LC, Bisca G, Morita AA, Zabatiero J, Proenca M, Kovelis D, Pitta F. Reduction of physical activity in daily life and its determinants in smokers without airflow obstruction. Respirology. 2014 Apr;19(3):369-75. doi: 10.1111/resp.12236. Epub 2014 Feb 2.
PubMed 24483840
Hawari FI. The effect of habitual waterpipe tobacco smoking on pulmonary function and exercise capacity in young healthy males: A pilot study. Respir Med. 2017 Mar;124:102. doi: 10.1016/j.rmed.2017.02.006. Epub 2017 Feb 11. No abstract available.
PubMed 28237402
Mesquita R, Goncalves CG, Hayashi D, Costa Vde S, Teixeira Dde C, de Freitas ER, Felcar JM, Pitta F, Molari M, Probst VS. Smoking status and its relationship with exercise capacity, physical activity in daily life and quality of life in physically independent, elderly individuals. Physiotherapy. 2015 Mar;101(1):55-61. doi: 10.1016/j.physio.2014.04.008. Epub 2014 May 17.
PubMed 25108641
Ben Saad H, Babba M, Boukamcha R, Ghannouchi I, Latiri I, Mezghenni S, Zedini C, Rouatbi S. Investigation of exclusive narghile smokers: deficiency and incapacity measured by spirometry and 6-minute walk test. Respir Care. 2014 Nov;59(11):1696-709. doi: 10.4187/respcare.03058. Epub 2014 Jul 8.
PubMed 25006270
Kobayashi Y, Takeuchi T, Hosoi T, Loeppky JA. Effects of habitual smoking on cardiorespiratory responses to sub-maximal exercise. J Physiol Anthropol Appl Human Sci. 2004 Sep;23(5):163-9. doi: 10.2114/jpa.23.163.
PubMed 15472461
Neves CD, Lacerda AC, Lage VK, Lima LP, Tossige-Gomes R, Fonseca SF, Rocha-Vieira E, Teixeira MM, Mendonca VA. Oxidative stress and skeletal muscle dysfunction are present in healthy smokers. Braz J Med Biol Res. 2016 Oct 24;49(11):e5512. doi: 10.1590/1414-431X20165512.
PubMed 27783809
Morse CI, Wust RC, Jones DA, de Haan A, Degens H. Muscle fatigue resistance during stimulated contractions is reduced in young male smokers. Acta Physiol (Oxf). 2007 Oct;191(2):123-9. doi: 10.1111/j.1748-1716.2007.01721.x. Epub 2007 Jun 5.
PubMed 17550408

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Cigarette Smoking trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Association of Cigarette Smoking on Exercise Capacity and Skeletal Muscle Function in Taiwan Adult Smokers
ClinicalTrials.gov ID: NCT04688177
Acronym / sponsor ID: 202010123RIND
Conditions: Cigarette Smoking
Keywords: cigarette smoking, exercise capacity, skeletal muscle function, heart rate variability
Study type: Observational
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: National Taiwan University HospitalUniversity, hospital or other
Study start: 3 Dec 2020 (actual)
Primary completion: 29 Apr 2021 (actual)
Study completion: 29 Apr 2021 (actual)
First posted: 29 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
smokers	–	Device: Body Composition, Device: Heart rate variability, Device: Grip Strength, Device: Exhale Carbon Monoxide Concentration, Device: Pulmonary Function Test, Device: Respiratory Muscle Function, Behavioral: Fagerström Test for Nicotine Dependence, Behavioral: Seven-Day Physical Activity Recall Questionnaire, Device: Cardiopulmonary exercise testingcigarette smokers male 20 ≤ age ≤ 45 years old female 20 ≤ age ≤ 55 years old
never smokers	–	Device: Body Composition, Device: Heart rate variability, Device: Grip Strength, Device: Exhale Carbon Monoxide Concentration, Device: Pulmonary Function Test, Device: Respiratory Muscle Function, Behavioral: Fagerström Test for Nicotine Dependence, Behavioral: Seven-Day Physical Activity Recall Questionnaire, Device: Cardiopulmonary exercise testingage and gender-matched non-smokers

Who may qualify

Ages: 20 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: Subjects will be invited from community in Taipei City

Key inclusion criteria (3 listed)

male 20 ≤ age ≤ 45 years old
female 20 ≤ age ≤ 55 years old
age and gender-matched non-smokers

Key exclusion criteria (4 listed)

uncontrolled cardiovascular diseases, neurological diseases, musculoskeletal system problems, or systemic diseases that contraindicate the exercise
women in pregnancy or menopausal women
any ongoing medication that has a documented effect on the autonomic nervous system (e.g., tricyclic anti-depressants)
has been diagnosed with autonomic nervous system disorders

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Body CompositionThe subjects should lie in the supine position on a non-conducting surface for 5 min. 4 surface electrodes with cables will be attached to the right hand and ankle of subjects.	Device	never smokers, smokers
Heart rate variabilityAfter supine quietly for 20 min, a lead I electrocardiogram will be taken for 5 min.	Device	never smokers, smokers
Grip StrengthThe participants will squeeze the hand dynamometer as hard as possible with the dominant hand. 3 successive measurements will be taken.	Device	never smokers, smokers
Exhale Carbon Monoxide ConcentrationSubjects in sitting position, performing 1 inspiration, then exhale to carbon monoxide meter.	Device	never smokers, smokers
Pulmonary Function TestSubjects should be in a sitting position with a nose clip, then perform pulmonary function test. Participants should perform at least 3 acceptable attempts, but no more than 8 attempts in total.	Device	never smokers, smokers
Respiratory Muscle FunctionSubject will perform both maximal inspiratory pressure and maximal expiratory pressure for 3 times in sitting position with the nose clip.	Device	never smokers, smokers
Fagerström Test for Nicotine DependenceFagerström Test for Nicotine Dependence Traditional Chinese version will be adopted. It is a 6-item questionnaire that could help quantify the smoking frequency, amounts, and level of dependence.	Behavioural	never smokers, smokers
Seven-Day Physical Activity Recall QuestionnairePhysical activity will be measured by the Chinese Version of the Seven-Day Physical Activity Recall Questionnaire. Participants will need to recall the time (hours) they spent in various leisure activities in the past 7 days.	Behavioural	never smokers, smokers
Cardiopulmonary exercise testingBruce protocol as the treadmill evaluation protocol will be adopted for cardiopulmonary exercise testing.	Device	never smokers, smokers

Primary outcome

Maximal oxygen uptake
Time frame: After finishing all the other measurement. The measurement will be lasted 15 minutes.
Maximal oxygen uptake, VO2max (ml/kg/min), as an indicator of exercise capacity. Cardiopulmonary exercise testing will be used to evaluate the maximal exercise capacity by a computer-controlled breath-by-breath metabolic measurement system (Carefusion Corporation, Yorba Linda, CA, USA) base on the treadmill. Bruce protocol, which is a graded treadmill evaluation protocol will be adopted.

10 secondary outcomes

Skeletal muscle function
Time frame: After finishing heart rate variability and body composition measurement. The measurement will be lasted 5 minutes.
Cardiac autonomic function
Time frame: After body composition measurement. The measurement will be lasted 20 minutes.
Skeletal muscle mass
Time frame: After collecting basic data of subjects. The measurement will be lasted 5-10 minutes.
Exhale carbon monoxide concentration
Time frame: After finishing heart rate variability and body composition measurement. The measurement will be lasted 1-3 minutes.
Forced expiratory volume in one second
Time frame: The pulmonary function measurement will be lasted 15 minutes.
Forced vital capacity
Time frame: The pulmonary function measurement will be lasted 15 minutes.
FEV1/FVC ratio
Time frame: The pulmonary function measurement will be lasted 15 minutes.
Respiratory muscle function
Time frame: After pulmonary function test measurement. The measurement will be lasted 10 minutes.
Level of nicotine dependence
Time frame: After respiratory muscle function measurement. The measurement will be lasted 3-5 minutes.
Seven-day physical activity recall questionnaire
Time frame: After respiratory muscle function measurement. The measurement will be lasted 3-5 minutes.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
Background: PubMed 29346338Jamal A, Phillips E, Gentzke AS, Homa DM, Babb SD, King BA, Neff LJ. Current Cigarette Smoking Among Adults - United States, 2016. MMWR Morb Mortal Wkly Rep. 2018 Jan 19;67(2):53-59. doi: 10.15585/mmwr.mm6702a1.
Background: PubMed 30175730Chen YL, Wu SC, Chen YT, Hsiao PC, Yu YH, Ting TT, Chen CY, Tu YK, Huang JH, Yang HJ, Li CY, Strong C, Yen CF, Yen CF, Chen WJ. E-Cigarette Use in a Country With Prevalent Tobacco Smoking: A Population-Based Study in Taiwan. J Epidemiol. 2019 Apr 5;29(4):155-163. doi: 10.2188/jea.JE20170300. Epub 2018 Sep 1.
Background: PubMed 17615396Yoshida T, Tuder RM. Pathobiology of cigarette smoke-induced chronic obstructive pulmonary disease. Physiol Rev. 2007 Jul;87(3):1047-82. doi: 10.1152/physrev.00048.2006.
Background: PubMed 29788259Tindle HA, Stevenson Duncan M, Greevy RA, Vasan RS, Kundu S, Massion PP, Freiberg MS. Lifetime Smoking History and Risk of Lung Cancer: Results From the Framingham Heart Study. J Natl Cancer Inst. 2018 Nov 1;110(11):1201-1207. doi: 10.1093/jnci/djy041.
Background: PubMed 23343064Thun MJ, Carter BD, Feskanich D, Freedman ND, Prentice R, Lopez AD, Hartge P, Gapstur SM. 50-year trends in smoking-related mortality in the United States. N Engl J Med. 2013 Jan 24;368(4):351-64. doi: 10.1056/NEJMsa1211127.
Background: PubMed 16920470Teo KK, Ounpuu S, Hawken S, Pandey MR, Valentin V, Hunt D, Diaz R, Rashed W, Freeman R, Jiang L, Zhang X, Yusuf S; INTERHEART Study Investigators. Tobacco use and risk of myocardial infarction in 52 countries in the INTERHEART study: a case-control study. Lancet. 2006 Aug 19;368(9536):647-58. doi: 10.1016/S0140-6736(06)69249-0.
Background: PubMed 30967285Watson M, Dardari Z, Kianoush S, Hall ME, DeFilippis AP, Keith RJ, Benjamin EJ, Rodriguez CJ, Bhatnagar A, Lima JA, Butler J, Blaha MJ, Rifai MA. Relation Between Cigarette Smoking and Heart Failure (from the Multiethnic Study of Atherosclerosis). Am J Cardiol. 2019 Jun 15;123(12):1972-1977. doi: 10.1016/j.amjcard.2019.03.015. Epub 2019 Mar 18.
Background: PubMed 15213107Doll R, Peto R, Boreham J, Sutherland I. Mortality in relation to smoking: 50 years' observations on male British doctors. BMJ. 2004 Jun 26;328(7455):1519. doi: 10.1136/bmj.38142.554479.AE. Epub 2004 Jun 22.
Background: PubMed 24483840Furlanetto KC, Mantoani LC, Bisca G, Morita AA, Zabatiero J, Proenca M, Kovelis D, Pitta F. Reduction of physical activity in daily life and its determinants in smokers without airflow obstruction. Respirology. 2014 Apr;19(3):369-75. doi: 10.1111/resp.12236. Epub 2014 Feb 2.
Background: PubMed 28237402Hawari FI. The effect of habitual waterpipe tobacco smoking on pulmonary function and exercise capacity in young healthy males: A pilot study. Respir Med. 2017 Mar;124:102. doi: 10.1016/j.rmed.2017.02.006. Epub 2017 Feb 11. No abstract available.
Background: PubMed 25108641Mesquita R, Goncalves CG, Hayashi D, Costa Vde S, Teixeira Dde C, de Freitas ER, Felcar JM, Pitta F, Molari M, Probst VS. Smoking status and its relationship with exercise capacity, physical activity in daily life and quality of life in physically independent, elderly individuals. Physiotherapy. 2015 Mar;101(1):55-61. doi: 10.1016/j.physio.2014.04.008. Epub 2014 May 17.
Background: PubMed 25006270Ben Saad H, Babba M, Boukamcha R, Ghannouchi I, Latiri I, Mezghenni S, Zedini C, Rouatbi S. Investigation of exclusive narghile smokers: deficiency and incapacity measured by spirometry and 6-minute walk test. Respir Care. 2014 Nov;59(11):1696-709. doi: 10.4187/respcare.03058. Epub 2014 Jul 8.
Health Promotion Administration, Ministry of Health and Welfare, Taiwan. Taiwan Tobacco Control Annual Report 2015. 2015.Link provided by the sponsor.
Liu JY, Chen TJ, Hwang SJ. Predicting Factors of Smoking Cessation in Outpatient Smoking Cessation Clinic. Taiwan J Fam Med 2017; 27: 146-153.Link provided by the sponsor.
Tsai YM. The Effect of Smoking on the Recuperation after Exercise. Journal of Exercise Physiology and Fitness, (3), 2005.Link provided by the sponsor.
Chung CY, Hung CC, Hwang SJ, Chen HC. The Application of Bioimpedance Analysis in Internal Medicine. J Intern Med Taiwan 2012; 23: 245-253.Link provided by the sponsor.
衛生福利部國民健康署健康九九網站。尼古丁成癮度量表。2020。Access date: 2020/07/28.Link provided by the sponsor.
Chien MY, Wu TY, Kwan WK, Chien CL. Reliability of the Chinese Version of the 7-day Recall Physical Activity Questionnaire and Its Correlation with Impairments of Disease and Function. FJPT 2003; 28(1):01-08.Link provided by the sponsor.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cigarette Smoking, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal oxygen uptake (time frame: After finishing all the other measurement. The measurement will be lasted 15 minutes.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04688177, which also lists 57 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.