Effects of Aerobic Combined With Diaphragmatic Breathing Exercise in Smokers

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05953987
• Other study ID #: EX PHYSIO SPSC 7
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: February 25, 2023

Study information

• Verified date: July 2023
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 25, 2023
• Est. primary completion date: February 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoker Lung
• Smoking Cessation

Intervention

Other:
• aerobic combined with diaphragmatic breathing exercise (EXDB)
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)
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)
The participant did not engage in the aerobic exercise training protocol or receive any form of supplementation during the study trial.

Locations

Country	Name	City	State
Thailand	Faculty of Sports Science, Chulalongkorn University	Pathum Wan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (6)

Dugral E, Balkanci D. Effects of smoking and physical exercise on respiratory function test results in students of university: A cross-sectional study. Medicine (Baltimore). 2019 Aug;98(32):e16596. doi: 10.1097/MD.0000000000016596. — View Citation

Gibbs K, Collaco JM, McGrath-Morrow SA. Impact of Tobacco Smoke and Nicotine Exposure on Lung Development. Chest. 2016 Feb;149(2):552-561. doi: 10.1378/chest.15-1858. Epub 2016 Jan 12. — View Citation

Jayes L, Haslam PL, Gratziou CG, Powell P, Britton J, Vardavas C, Jimenez-Ruiz C, Leonardi-Bee J; Tobacco Control Committee of the European Respiratory Society. SmokeHaz: Systematic Reviews and Meta-analyses of the Effects of Smoking on Respiratory Health. Chest. 2016 Jul;150(1):164-79. doi: 10.1016/j.chest.2016.03.060. Epub 2016 Apr 19. — View Citation

Liu JF, Kuo NY, Fang TP, Chen JO, Lu HI, Lin HL. A six-week inspiratory muscle training and aerobic exercise improves respiratory muscle strength and exercise capacity in lung cancer patients after video-assisted thoracoscopic surgery: A randomized controlled trial. Clin Rehabil. 2021 Jun;35(6):840-850. doi: 10.1177/0269215520980138. Epub 2020 Dec 14. — View Citation

Seo K, Park SH, Park K. Effects of diaphragm respiration exercise on pulmonary function of male smokers in their twenties. J Phys Ther Sci. 2015 Jul;27(7):2313-5. doi: 10.1589/jpts.27.2313. Epub 2015 Jul 22. — View Citation

Simmons MS, Connett JE, Nides MA, Lindgren PG, Kleerup EC, Murray RP, Bjornson WM, Tashkin DP. Smoking reduction and the rate of decline in FEV(1): results from the Lung Health Study. Eur Respir J. 2005 Jun;25(6):1011-7. doi: 10.1183/09031936.05.00086804. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function	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.	Change from Baseline pulmonary function at 8 weeks.
Primary	Smoking cessation	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	Change from Baseline Smoking cessation at 8 weeks, and 12 weeks
Primary	Urine cotinine	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	Change from Baseline Urine cotinine at 8 weeks, and 12 weeks
Secondary	Respiratory muscle strength	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.	Change from Baseline Respiratory muscle strength at 8 weeks.