NCT05953987

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

July 12, 2023

Last Update Submit

July 12, 2023

Conditions

Keywords

SmokerAerobic exerciseRespiratory muscle strength

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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

  • 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 Outcomes (1)

  • Respiratory muscle strength

    Change from Baseline Respiratory muscle strength at 8 weeks.

Study Arms (3)

aerobic combined with diaphragmatic breathing exercise (EXDB)

EXPERIMENTAL

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)

aerobic exercise (EX)

EXPERIMENTAL

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)

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.

Other: sedentary control (CON)

Interventions

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 combined with diaphragmatic breathing exercise (EXDB)

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.

aerobic exercise (EX)

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

sedentary control (CON)

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sports Science, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

Related Publications (6)

  • 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.

    PMID: 27102185BACKGROUND
  • 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.

    PMID: 31393359BACKGROUND
  • 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.

    PMID: 26502117BACKGROUND
  • 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.

    PMID: 15929955BACKGROUND
  • 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.

    PMID: 33307766BACKGROUND
  • 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.

    PMID: 26311972BACKGROUND

MeSH Terms

Conditions

Smoking Cessation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Wannaporn Tongtako, Ph.D.

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2023

First Posted

July 20, 2023

Study Start

June 1, 2022

Primary Completion

February 25, 2023

Study Completion

February 25, 2023

Last Updated

July 20, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations