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

NCT04688177 | Completed

• 1 other identifier: 202010123RIND
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking

Keywords

cigarette smoking; exercise capacity; skeletal muscle function; heart rate variability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Skeletal muscle function

  After finishing heart rate variability and body composition measurement. The measurement will be lasted 5 minutes.

• Cardiac autonomic function

  After body composition measurement. The measurement will be lasted 20 minutes.

• Skeletal muscle mass

  After collecting basic data of subjects. The measurement will be lasted 5-10 minutes.

• Exhale carbon monoxide concentration

  After finishing heart rate variability and body composition measurement. The measurement will be lasted 1-3 minutes.

• Forced expiratory volume in one second

  The pulmonary function measurement will be lasted 15 minutes.

Study Arms (2)

smokers

cigarette smokers male 20 ≤ age ≤ 45 years old female 20 ≤ age ≤ 55 years old

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

never smokers

age and gender-matched non-smokers

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

Interventions

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.

never smokers; smokers

Heart rate variability DEVICE

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

never smokers; smokers

Grip Strength DEVICE

The participants will squeeze the hand dynamometer as hard as possible with the dominant hand. 3 successive measurements will be taken.

never smokers; smokers

Exhale Carbon Monoxide Concentration DEVICE

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

never smokers; smokers

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.

never smokers; smokers

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.

never smokers; smokers

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.

never smokers; smokers

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.

never smokers; smokers

Cardiopulmonary exercise testing DEVICE

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

never smokers; smokers

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subjects will be invited from community in Taipei City

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

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

Taipei, Zhongzheng, 100, Taiwan

Location

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Related Links

• 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.

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Hand Strength; Respiratory Function Tests; Exercise Test

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diagnostic Techniques, Respiratory System; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Ergometry; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 29, 2020
• Study Start: December 3, 2020
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: January 24, 2022

Record last verified: 2020-12

Locations

TW (1)