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CompletedNCT05953987Updated Jul 20, 2023

Effects of Aerobic Combined With Diaphragmatic Breathing Exercise in Smokers

An interventional study of aerobic combined with diaphragmatic breathing exercise (EXDB) and aerobic exercise (EX) in Smoker Lung and Smoking Cessation, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-07-20.

Sponsored by Chulalongkorn University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jun 2022, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Smoker Lung
  • Smoking Cessation

Keywords

  • Smoker
  • Aerobic exercise
  • Respiratory muscle strength
03

In context

Lead sponsor

Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    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.

    Other: aerobic combined with diaphragmatic breathing exercise (EXDB)

  • Experimental
    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.

    Other: aerobic exercise (EX)

  • Other
    sedentary control (CON)

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

    Other: sedentary control (CON)

Interventions

  • Otheraerobic 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

  • Otheraerobic 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.

  • Othersedentary control (CON)

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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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

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

  3. 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

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

Secondary outcomes

  1. 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.

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

07

Study locations

1 site
  • Faculty of Sports Science, Chulalongkorn University
    Pathum Wan, Bangkok 10330, Thailand
08

References and documents

Publications

  • 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. PubMed 27102185 ↗
  • 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. PubMed 31393359 ↗
  • 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. PubMed 26502117 ↗
  • 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. PubMed 15929955 ↗
  • 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. PubMed 33307766 ↗
  • 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. PubMed 26311972 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05953987
Lead sponsor
Chulalongkorn University
Responsible party
Sponsor
First posted
Jul 20, 2023
Start date
Jun 1, 2022
Primary completion
Feb 25, 2023
Completion
Feb 25, 2023
Last update
Jul 20, 2023

Study contacts

Wannaporn Tongtako, Ph.D.
principal investigator · Area of Exercise Physiology, Faculty of Sports Science, Chulalongkorn University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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