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Completed

NCT Number: NCT05953987

Effects of Aerobic Combined With Diaphragmatic Breathing Exercise in Smokers

This study aimed to evaluate the effectiveness of aerobic exercise combined with diaphragmatic breathing exercise on pulmonary function and smoking cessation among smokers.

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Sports Science, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

About this study

Twenty-four smokers aged between 20 and 45 years were allocated into 3 groups: a sedentary control group (CON, n = 8), an aerobic exercise group (EX, n = 8), and an aerobic combined with diaphragmatic breathing exercise group (EXDB, n = 8). The general physiological characteristics, pulmonary function, and respiratory muscle strength values before and after 8 weeks were meas-ured. The Quit Smoking Questionnaire and urine cotinine were measured for either 30 days after the training.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible individuals included those who set the quit date within 7 days from the date of calling the TNQ. The participants have smoked more than or equal to 10 cigarettes per day for at least 1 year and had a body mass index of not more than 24.9 kg/m2. More-over, they were screened for the health risks of exercise by the Physical Activity Readiness Questionnaire (PAR-Q). They must not have exercised for 30 minutes or more at least three times a week for the past six months.

Exclusion criteria

  • This study excluded participants with a history of respiratory system diseases such as pulmonary tuberculosis, asthma, chronic obstructive pulmonary disease, lung cancer, etc. and who were using nicotine replacement therapy.

Treatment and study plan

aerobic combined with diaphragmatic breathing exercise (EXDB)

Other

The participant underwent diaphragmatic breathing exercises which were performed in a supine position, gradually in-creasing the weight by 2.5 kg in weeks 1-4 and further increasing to 5 kg in weeks 5-8. After completing the prescribed breathing exercises and taking a 60-second rest, participants proceeded to perform aerobic exercises, either by running on a treadmill or on a regular floor surface. Each training session began with a 5-minute warm-up comprising stretching exercises. In weeks 1-4, moderate intensity was maintained, targeting 40-50% of the heart rate reserve (HRR) for a duration of 60 minutes. From weeks 5-8, the intensity increased to the range of 51-60% of the heart rate reserve, and a 5-minute cool down was added

aerobic exercise (EX)

Other

The participant underwent aerobic exercises, either by running on a treadmill or on a regular floor surface. Each training session began with a 5-minute warm-up comprising stretching exercises. In weeks 1-4, moderate intensity was maintained, targeting 40-50% of the heart rate reserve (HRR) for a duration of 60 minutes. From weeks 5-8, the intensity increased to the range of 51-60% of the heart rate reserve, and a 5-minute cool down was added.

sedentary control (CON)

Other

The participant did not engage in the aerobic exercise training protocol or receive any form of supplementation during the study trial.

Primary outcomes

  1. Pulmonary function

    Time frame: Change from Baseline pulmonary function at 8 weeks.

    The anticipated value and liters of FVC, FEV1, and MVV maneuver were measured using a computerized spirometer (SpirobankG) in accordance with the pulmonary function test criteria of the American Thoracic Society. Participants were asked to sit on a chair with a nasal clip on. Before demonstrating forced inspiration and expiration and returning to normal breathing, three cycles of slow normal breathing were performed. Participants were instructed to inhale and exhale quickly and strongly for 15 seconds during the MVV maneuver.

  2. Smoking cessation

    Time frame: Change from Baseline Smoking cessation at 8 weeks, and 12 weeks

    The Quit Smoking Questionnaire was utilized to evaluate the smoking status of each participant by posing the following question: "Did you refrain from smoking continuously for a minimum of 7 days after your designated quit date?" If the response was affirmative, the participants were further inquired about their continuous abstinence for either 30 days after the training. Four items within the questionnaire yielded a Cronbach's alpha coefficient of 0.93

  3. Urine cotinine

    Time frame: Change from Baseline Urine cotinine at 8 weeks, and 12 weeks

    The Direct Barbituric Acid (DBA) reaction method was utilized to measure urine cotinine. The results were interpreted based on the color change observed in the urine sample. Each morning, a urine sample of 30-50 ml was collected and added to the urinary cotinine measurement kit by participants. The color of the sample was then com-pared to the standard color band for urinary cotinine, and pictures were taken to be sent to the researchers. Assessment was conducted at 30 days after training, and the results were categorized as either "found" or "not found" based on the color change observed in the test tabs

Secondary outcomes

  1. Respiratory muscle strength

    Time frame: Change from Baseline Respiratory muscle strength at 8 weeks.

    A portable handheld mouth pressure meter (Micro RPM England) was used to test respiratory muscle strength. For the MIP assessment, participants were told to exhale until they felt no air remaining in their lungs (starting at the functional residual capacity [FRC]). They then inhaled for 1-2 seconds while holding the item in their mouth. For the MEP measurement, participants were told to inhale until their lungs were completely filled with air (beginning with the total lung capacity [TLC] point). They then exhaled strongly while holding the device in their lips for 1-2 seconds.

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Effects of Aerobic Combined With Diaphragmatic Breathing Exercise on Pulmonary Function, Smoking Cessation, and Urine Cotinine Among Smokers

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2023
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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