- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05953987
Effects of Aerobic Combined With Diaphragmatic Breathing Exercise in Smokers
July 12, 2023 updated by: Chulalongkorn University
Effects of Aerobic Combined With Diaphragmatic Breathing Exercise on Pulmonary Function, Smoking Cessation, and Urine Cotinine Among Smokers
This study aimed to evaluate the effectiveness of aerobic exercise combined with diaphragmatic breathing exercise on pulmonary function and smoking cessation among smokers.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
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
-
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Bangkok
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Pathum Wan, Bangkok, Thailand, 10330
- Faculty of Sports Science, Chulalongkorn University
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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
- Adult
Accepts Healthy Volunteers
No
Description
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.
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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
|
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.
|
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: sedentary control (CON)
The participant did not engage in the aerobic exercise training protocol or receive any form of supplementation during the study trial.
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The participant did not engage in the aerobic exercise training protocol or receive any form of supplementation during the study trial.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Change from Baseline pulmonary function at 8 weeks.
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Smoking cessation
Time Frame: Change from Baseline Smoking cessation at 8 weeks, and 12 weeks
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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
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Change from Baseline Smoking cessation at 8 weeks, and 12 weeks
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Urine cotinine
Time Frame: Change from Baseline Urine cotinine at 8 weeks, and 12 weeks
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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
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Change from Baseline Urine cotinine at 8 weeks, and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory muscle strength
Time Frame: Change from Baseline Respiratory muscle strength at 8 weeks.
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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.
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Change from Baseline Respiratory muscle strength at 8 weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wannaporn Tongtako, Ph.D., Area of Exercise Physiology, Faculty of Sports Science, Chulalongkorn University
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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)
June 1, 2022
Primary Completion (Actual)
February 25, 2023
Study Completion (Actual)
February 25, 2023
Study Registration Dates
First Submitted
July 12, 2023
First Submitted That Met QC Criteria
July 12, 2023
First Posted (Actual)
July 20, 2023
Study Record Updates
Last Update Posted (Actual)
July 20, 2023
Last Update Submitted That Met QC Criteria
July 12, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- EX PHYSIO SPSC 7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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