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Completed

NCT Number: NCT04688177

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

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.

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Key information

Conditions

Cigarette Smoking Behavior Smoking Tobacco Smoking Tobacco Use

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University, College of Medicine, Department of Physical Therapy

Taipei, Zhongzheng, 100, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Body composition

Device

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

Device

After supine quietly for 20 min, a lead I electrocardiogram will be taken for 5 min.

Grip Strength

Device

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

Device

Subjects in sitting position, performing 1 inspiration, then exhale to carbon monoxide meter.

Pulmonary Function Test

Device

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

Device

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

Behavioral

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

Behavioral

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

Device

Bruce protocol as the treadmill evaluation protocol will be adopted for cardiopulmonary exercise testing.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Skeletal muscle function

    Time frame: 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).

  2. Cardiac autonomic function

    Time frame: 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.

  3. Skeletal muscle mass

    Time frame: 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.

  4. Exhale carbon monoxide concentration

    Time frame: 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.

  5. Forced expiratory volume in one second

    Time frame: 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).

  6. Forced vital capacity

    Time frame: 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)

  7. FEV1/FVC ratio

    Time frame: 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.

  8. Respiratory muscle function

    Time frame: 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.

  9. Level of nicotine dependence

    Time frame: 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.

  10. Seven-day physical activity recall questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2020
Registry last updated
Jan 24, 2022

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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