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

Completed

• Conditions: Cigarette Smoking
• Interventions: 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

• Registration Number: NCT04688177
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study Start: 2020-12-03
• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2020-12-24
• Study First Posted: 2020-12-29
• Primary Completion: 2021-04-29
• Study Completion: 2021-04-29
• Last Update Submitted: 2022-01-21
• Last Update Posted: 2022-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
never smokers	Cardiopulmonary exercise testing	age and gender-matched non-smokers
smokers	Exhale Carbon Monoxide Concentration	cigarette smokers male 20 ≤ age ≤ 45 years old female 20 ≤ age ≤ 55 years old
never smokers	Fagerström Test for Nicotine Dependence	age and gender-matched non-smokers
smokers	Heart rate variability	cigarette smokers male 20 ≤ age ≤ 45 years old female 20 ≤ age ≤ 55 years old
smokers	Grip Strength	cigarette smokers male 20 ≤ age ≤ 45 years old female 20 ≤ age ≤ 55 years old
smokers	Pulmonary Function Test	cigarette smokers male 20 ≤ age ≤ 45 years old female 20 ≤ age ≤ 55 years old
never smokers	Body Composition	age and gender-matched non-smokers
never smokers	Pulmonary Function Test	age and gender-matched non-smokers
smokers	Fagerström Test for Nicotine Dependence	cigarette smokers male 20 ≤ age ≤ 45 years old female 20 ≤ age ≤ 55 years old
never smokers	Grip Strength	age and gender-matched non-smokers
smokers	Body Composition	cigarette smokers male 20 ≤ age ≤ 45 years old female 20 ≤ age ≤ 55 years old
smokers	Respiratory Muscle Function	cigarette smokers male 20 ≤ age ≤ 45 years old female 20 ≤ age ≤ 55 years old
smokers	Seven-Day Physical Activity Recall Questionnaire	cigarette smokers male 20 ≤ age ≤ 45 years old female 20 ≤ age ≤ 55 years old
smokers	Cardiopulmonary exercise testing	cigarette smokers male 20 ≤ age ≤ 45 years old female 20 ≤ age ≤ 55 years old
never smokers	Heart rate variability	age and gender-matched non-smokers
never smokers	Exhale Carbon Monoxide Concentration	age and gender-matched non-smokers
never smokers	Respiratory Muscle Function	age and gender-matched non-smokers
never smokers	Seven-Day Physical Activity Recall Questionnaire	age and gender-matched non-smokers

Primary Outcome Measures

Name	Time	Method
Maximal oxygen uptake	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.

Secondary Outcome Measures

Name	Time	Method
Seven-day physical activity recall questionnaire	After respiratory muscle function measurement. The measurement will be lasted 3-5 minutes.	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.
Skeletal muscle mass	After collecting basic data of subjects. The measurement will be lasted 5-10 minutes.	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.
Skeletal muscle function	After finishing heart rate variability and body composition measurement. The measurement will be lasted 5 minutes.	Skeletal muscle function will be assessed by measuring the grip strength of the dominant hand using a hand dynamometer (Jamar, Jackson, MI, USA).
Cardiac autonomic function	After body composition measurement. The measurement will be lasted 20 minutes.	Heart rate variability will be measured by HRV monitor (8Z11, Wegene Technology Inc., Taiwan) in this study.
Exhale carbon monoxide concentration	After finishing heart rate variability and body composition measurement. The measurement will be lasted 1-3 minutes.	Exhale carbon monoxide will be measured by the carbon monoxide meter (CO Check+, MD Diagnostics LTD) for current smoking status evaluation.
Forced expiratory volume in one second	The pulmonary function measurement will be lasted 15 minutes.	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).
Forced vital capacity	The pulmonary function measurement will be lasted 15 minutes.	Pulmonary function will be measured by a portable MicroLab® Spirometer (CareFusion, Basingstoke, UK). The outcome measure will include: forced vital capacity (FVC, unit: liter)
FEV1/FVC ratio	The pulmonary function measurement will be lasted 15 minutes.	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.
Level of nicotine dependence	After respiratory muscle function measurement. The measurement will be lasted 3-5 minutes.	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.
Respiratory muscle function	After pulmonary function test measurement. The measurement will be lasted 10 minutes.	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.

Trial Locations

Locations (1)

National Taiwan University, College of Medicine, Department of Physical Therapy; 🇨🇳 Taipei, Zhongzheng, Taiwan