Clinical trial NCT04688177: The Association of Cigarette Smoking on Exercise Capacity and Skeletal Muscle Function in Taiwan Adult Smokers
Official title: The Association of Cigarette Smoking on Exercise Capacity and Skeletal Muscle Function in Taiwan Adult Smokers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cigarette Smoking
Keywords: cigarette smoking
exercise capacity
skeletal muscle function
heart rate variability
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be invited from community in Taipei City

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximal oxygen uptake
timeFrame: After finishing all the other measurement. The measurement will be lasted 15 minutes.
Secondary outcomes:
measure: Skeletal muscle function
timeFrame: After finishing heart rate variability and body composition measurement. The measurement will be lasted 5 minutes.
measure: Cardiac autonomic function
timeFrame: After body composition measurement. The measurement will be lasted 20 minutes.
measure: Skeletal muscle mass
timeFrame: After collecting basic data of subjects. The measurement will be lasted 5-10 minutes.
measure: Exhale carbon monoxide concentration
timeFrame: After finishing heart rate variability and body composition measurement. The measurement will be lasted 1-3 minutes.
measure: Forced expiratory volume in one second
timeFrame: The pulmonary function measurement will be lasted 15 minutes.
measure: Forced vital capacity
timeFrame: The pulmonary function measurement will be lasted 15 minutes.
measure: FEV1/FVC ratio
timeFrame: The pulmonary function measurement will be lasted 15 minutes.
measure: Respiratory muscle function
timeFrame: After pulmonary function test measurement. The measurement will be lasted 10 minutes.
measure: Level of nicotine dependence
timeFrame: After respiratory muscle function measurement. The measurement will be lasted 3-5 minutes.
measure: Seven-day physical activity recall questionnaire
timeFrame: After respiratory muscle function measurement. The measurement will be lasted 3-5 minutes.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University, College of Medicine, Department of Physical Therapy
state: Zhongzheng
Study officials:
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