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

Cigarette Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04688177
• Other study ID #: 202010123RIND
• Status: Completed
• Start date: December 3, 2020
• Est. completion date: April 29, 2021

Study information

• Verified date: December 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 29, 2021
• Est. primary completion date: April 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• male 20 = age = 45 years old

• female 20 = age = 55 years old

• age and gender-matched non-smokers

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Device:
• 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.

Behavioral:
• 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.

Device:
• Cardiopulmonary exercise testing
Bruce protocol as the treadmill evaluation protocol will be adopted for cardiopulmonary exercise testing.

Locations

Country	Name	City	State
Taiwan	National Taiwan University, College of Medicine, Department of Physical Therapy	Taipei	Zhongzheng

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

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* Note: There are 57 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After finishing all the other measurement. The measurement will be lasted 15 minutes.
Secondary	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).	After finishing heart rate variability and body composition measurement. The measurement will be lasted 5 minutes.
Secondary	Cardiac autonomic function	Heart rate variability will be measured by HRV monitor (8Z11, Wegene Technology Inc., Taiwan) in this study.	After body composition measurement. The measurement will be lasted 20 minutes.
Secondary	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.	After collecting basic data of subjects. The measurement will be lasted 5-10 minutes.
Secondary	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.	After finishing heart rate variability and body composition measurement. The measurement will be lasted 1-3 minutes.
Secondary	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).	The pulmonary function measurement will be lasted 15 minutes.
Secondary	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)	The pulmonary function measurement will be lasted 15 minutes.
Secondary	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.	The pulmonary function measurement will be lasted 15 minutes.
Secondary	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.	After pulmonary function test measurement. The measurement will be lasted 10 minutes.
Secondary	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.	After respiratory muscle function measurement. The measurement will be lasted 3-5 minutes.
Secondary	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.	After respiratory muscle function measurement. The measurement will be lasted 3-5 minutes.

External Links

•   ??????????????????????????2020?Access date: 2020/07/28.
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•   Chung CY, Hung CC, Hwang SJ, Chen HC. The Application of Bioimpedance Analysis in Internal Medicine. J Intern Med Taiwan 2012; 23: 245-253.
•   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.
•   World Health Organization. Obesity, high blood pressure, high cholesterol, alcohol and tobacco: The World Health Organization's response. 2020. Access date: 2020/07/23.