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

January 21, 2022 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Zhongzheng
      • Taipei, Zhongzheng, Taiwan, 100
        • National Taiwan University, College of Medicine, Department of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects will be invited from community in Taipei City

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
smokers
cigarette smokers male 20 ≤ age ≤ 45 years old female 20 ≤ age ≤ 55 years old
Device: Body 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.
Device: Heart rate variability
After supine quietly for 20 min, a lead I electrocardiogram will be taken for 5 min.
Device: Grip Strength
The participants will squeeze the hand dynamometer as hard as possible with the dominant hand. 3 successive measurements will be taken.
Device: Exhale Carbon Monoxide Concentration
Subjects in sitting position, performing 1 inspiration, then exhale to carbon monoxide meter.
Device: Pulmonary 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.
Device: Respiratory Muscle Function
Subject will perform both maximal inspiratory pressure and maximal expiratory pressure for 3 times in sitting position with the nose clip.
Behavioral: Fagerström 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.
Behavioral: Seven-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.
Device: Cardiopulmonary exercise testing
Bruce protocol as the treadmill evaluation protocol will be adopted for cardiopulmonary exercise testing.
never smokers
age and gender-matched non-smokers
Device: Body 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.
Device: Heart rate variability
After supine quietly for 20 min, a lead I electrocardiogram will be taken for 5 min.
Device: Grip Strength
The participants will squeeze the hand dynamometer as hard as possible with the dominant hand. 3 successive measurements will be taken.
Device: Exhale Carbon Monoxide Concentration
Subjects in sitting position, performing 1 inspiration, then exhale to carbon monoxide meter.
Device: Pulmonary 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.
Device: Respiratory Muscle Function
Subject will perform both maximal inspiratory pressure and maximal expiratory pressure for 3 times in sitting position with the nose clip.
Behavioral: Fagerström 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.
Behavioral: Seven-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.
Device: Cardiopulmonary exercise testing
Bruce protocol as the treadmill evaluation protocol will be adopted for cardiopulmonary exercise testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After finishing all the other measurement. The measurement will be lasted 15 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
After finishing heart rate variability and body composition measurement. The measurement will be lasted 5 minutes.
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.
After body composition measurement. The measurement will be lasted 20 minutes.
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.
After collecting basic data of subjects. The measurement will be lasted 5-10 minutes.
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.
After finishing heart rate variability and body composition measurement. The measurement will be lasted 1-3 minutes.
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).
The pulmonary function measurement will be lasted 15 minutes.
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)
The pulmonary function measurement will be lasted 15 minutes.
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.
The pulmonary function measurement will be lasted 15 minutes.
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.
After pulmonary function test measurement. The measurement will be lasted 10 minutes.
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.
After respiratory muscle function measurement. The measurement will be lasted 3-5 minutes.
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.
After respiratory muscle function measurement. The measurement will be lasted 3-5 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2020

Primary Completion (Actual)

April 29, 2021

Study Completion (Actual)

April 29, 2021

Study Registration Dates

First Submitted

December 14, 2020

First Submitted That Met QC Criteria

December 24, 2020

First Posted (Actual)

December 29, 2020

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 21, 2022

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202010123RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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