NCT04688177

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

Completed Last updated 24 January 2022

What this trial tests

trial testing Body Composition in Cigarette Smoking in 52 participants. Completed in 29 April 2021.

Timeline

3 December 2020

Primary endpoint
29 April 2021

29 April 2021

Quick facts

Lead sponsor	National Taiwan University Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	52
Start date	3 December 2020
Primary completion	29 April 2021
Estimated completion	29 April 2021
Sites	1 location across Taiwan

Drugs / interventions tested

• Body Composition
• Heart rate variability
• Grip Strength
• Exhale Carbon Monoxide Concentration
• Pulmonary Function Test
• Respiratory Muscle Function
• Fagerström Test for Nicotine Dependence
• Seven-Day Physical Activity Recall Questionnaire
• Cardiopulmonary exercise testing

Conditions studied

• Cigarette Smoking — all drugs for Cigarette Smoking →

Sponsor

National Taiwan University Hospital

Who can join

Adults 20 to 55, any sex, with Cigarette Smoking. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.