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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04688177
Enrollment
52
Registered
2020-12-29
Start date
2020-12-03
Completion date
2021-04-29
Last updated
2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking

Keywords

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

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.

Interventions

DEVICEBody 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.

DEVICEHeart rate variability

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

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

DEVICEExhale Carbon Monoxide Concentration

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

DEVICEPulmonary 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.

Subject will perform both maximal inspiratory pressure and maximal expiratory pressure for 3 times in sitting position with the nose clip.

BEHAVIORALFagerström 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.

BEHAVIORALSeven-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.

DEVICECardiopulmonary exercise testing

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Maximal oxygen uptakeAfter 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

MeasureTime frameDescription
Cardiac autonomic functionAfter 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.
Skeletal muscle massAfter 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.
Exhale carbon monoxide concentrationAfter 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 secondThe 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).
Skeletal muscle functionAfter 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).
FEV1/FVC ratioThe 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.
Respiratory muscle functionAfter 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.
Level of nicotine dependenceAfter 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.
Seven-day physical activity recall questionnaireAfter 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.
Forced vital capacityThe 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)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026