The Association of Cigarette Smoking on Exercise Capacity and Skeletal Muscle Function in Taiwan Adult Smokers
NCT ID: NCT04688177
Last Updated: 2022-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
52 participants
OBSERVATIONAL
2020-12-03
2021-04-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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smokers
cigarette smokers male 20 ≤ age ≤ 45 years old female 20 ≤ age ≤ 55 years old
Body Composition
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 variability
After supine quietly for 20 min, a lead I electrocardiogram will be taken for 5 min.
Grip Strength
The participants will squeeze the hand dynamometer as hard as possible with the dominant hand. 3 successive measurements will be taken.
Exhale Carbon Monoxide Concentration
Subjects in sitting position, performing 1 inspiration, then exhale to carbon monoxide meter.
Pulmonary Function Test
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 Function
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 Dependence
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 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.
Cardiopulmonary exercise testing
Bruce protocol as the treadmill evaluation protocol will be adopted for cardiopulmonary exercise testing.
never smokers
age and gender-matched non-smokers
Body Composition
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 variability
After supine quietly for 20 min, a lead I electrocardiogram will be taken for 5 min.
Grip Strength
The participants will squeeze the hand dynamometer as hard as possible with the dominant hand. 3 successive measurements will be taken.
Exhale Carbon Monoxide Concentration
Subjects in sitting position, performing 1 inspiration, then exhale to carbon monoxide meter.
Pulmonary Function Test
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 Function
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 Dependence
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 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.
Cardiopulmonary exercise testing
Bruce protocol as the treadmill evaluation protocol will be adopted for cardiopulmonary exercise testing.
Interventions
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Body Composition
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 variability
After supine quietly for 20 min, a lead I electrocardiogram will be taken for 5 min.
Grip Strength
The participants will squeeze the hand dynamometer as hard as possible with the dominant hand. 3 successive measurements will be taken.
Exhale Carbon Monoxide Concentration
Subjects in sitting position, performing 1 inspiration, then exhale to carbon monoxide meter.
Pulmonary Function Test
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 Function
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 Dependence
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 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.
Cardiopulmonary exercise testing
Bruce protocol as the treadmill evaluation protocol will be adopted for cardiopulmonary exercise testing.
Eligibility Criteria
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Inclusion Criteria
* female 20 ≤ age ≤ 55 years old
* age and gender-matched non-smokers
Exclusion Criteria
* 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
20 Years
55 Years
ALL
Yes
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Locations
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National Taiwan University, College of Medicine, Department of Physical Therapy
Taipei, Zhongzheng, Taiwan
Countries
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References
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Related Links
Access external resources that provide additional context or updates about the study.
Health Promotion Administration, Ministry of Health and Welfare, Taiwan. Taiwan Tobacco Control Annual Report 2015. 2015.
Liu JY, Chen TJ, Hwang SJ. Predicting Factors of Smoking Cessation in Outpatient Smoking Cessation Clinic. Taiwan J Fam Med 2017; 27: 146-153.
Tsai YM. The Effect of Smoking on the Recuperation after Exercise. Journal of Exercise Physiology and Fitness, (3), 2005.
Chung CY, Hung CC, Hwang SJ, Chen HC. The Application of Bioimpedance Analysis in Internal Medicine. J Intern Med Taiwan 2012; 23: 245-253.
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.
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.
Other Identifiers
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202010123RIND
Identifier Type: -
Identifier Source: org_study_id
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