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

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ClinicalTrials.gov Identifier: NCT04688177
Recruitment Status : Recruiting
First Posted : December 29, 2020
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.


Condition or disease Intervention/treatment
Cigarette Smoking 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

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Association of Cigarette Smoking on Exercise Capacity and Skeletal Muscle Function in Taiwan Adult Smokers
Actual Study Start Date : December 3, 2020
Estimated Primary Completion Date : December 2, 2021
Estimated Study Completion Date : December 2, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects will be invited from community in Taipei City
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04688177


Contacts
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Contact: Meng Yueh Chien, PhD 02-33668141 mychien@ntu.edu.tw

Locations
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Taiwan
National Taiwan University, College of Medicine, Department of Physical Therapy Recruiting
Taipei, Zhongzheng, Taiwan, 100
Contact: Meng Yueh Chien    02-33668141    mychien@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Additional Information:
Publications:

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04688177    
Other Study ID Numbers: 202010123RIND
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
cigarette smoking
exercise capacity
skeletal muscle function
heart rate variability
Additional relevant MeSH terms:
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Nicotine
Carbon Monoxide
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Gasotransmitters