NCT07882407

Brief Summary

This study aims to evaluate the effects of a six-week behavioral circuit breathing training intervention on smoking cessation and respiratory function compared with diaphragmatic breathing training and usual daily activities

Trial Health

77
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Sep 2026Dec 2026

Study Start

First participant enrolled

September 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 20, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

October 20, 2026

Status Verified

October 1, 2026

Enrollment Period

3 months

First QC Date

October 13, 2026

Last Update Submit

October 13, 2026

Conditions

Keywords

Smoking cessationRespiratory functionCircuit breathingPeak nasal inspiratory flow

Outcome Measures

Primary Outcomes (8)

  • Tobacco Craving Questionnaire-Short Form (TCQ-SF) Score

    Craving will be assessed using the 12-item TCQ-SF. The questionnaire is a self-report measure using a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater tobacco craving.

    Change from baseline Tobacco Craving Questionnaire-Short Form (TCQ-SF) score at 6 weeks.

  • Smoking Cessation Status and Behaviors

    This self-report questionnaire consists of seven items assessing 7-day point-prevalence abstinence, duration of smoking cessation, smoking cessation behaviors, and attempts to quit smoking.

    Change from baseline smoking cessation status and behaviors at 6 weeks.

  • Penn State Electronic Cigarette Dependence Index Score

    E-cigarette dependence will be assessed using the Penn State Electronic Cigarette Dependence Index. The scale consists of 10 items, with a maximum total score of 20.

    Change from baseline Penn State Electronic Cigarette Dependence Index score at 6 weeks.

  • Pulmonary function (Forced Expiratory Volume in one second; FEV1)

    The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FEV1 (L) will be reported in liter (L).

    Change from baseline FEV1 at 6 weeks.

  • Pulmonary function (The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs; FEV1/FVC)

    The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FEV1/FVC will be reported in percent (%).

    Change from baseline FEV1/FVC at 6 weeks.

  • Pulmonary function (Maximal voluntary ventilation; MVV)

    The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). During the MVV maneuver, participants were instructed to demonstrate in rapid and forceful inhalation and exhalation for a duration of 10 seconds. MVV will be reported in liter per minute (L/min).

    Change from baseline MVV at 6 weeks.

  • Pulmonary function (Forced expiratory flow at 25-75%)

    The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver.

    Change from baseline FEF 25-75% at 6 weeks.

  • Respiratory muscle strength

    Respiratory muscle strength was evaluated by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) in centimeters of water (cmH2O). The participants were seated and utilized a portable handheld mouth pressure meter (MicroRPM), along with a nose clip. To assess MIP, participants were instructed to exhale until they emptied their lungs at the point of functional residual capacity (FRC). Participants held the device to their mouth and forcefully inhaled for 1-2 seconds. For the measurement of MEP, participants were directed to inhale until their lungs were completely filled with air, starting from the total lung capacity (TLC) point. Participants were asked to maintain the device on their mouth and forcefully exhaled for 1-2 seconds.

    Change from baseline Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) at 6 weeks.

Secondary Outcomes (5)

  • WHOQOL-BREF Score

    Change from baseline WHOQOL-BREF Score at 6 weeks.

  • Pittsburgh Sleep Quality Index (PSQI) Global Score

    Change from baseline Pittsburgh Sleep Quality Index (PSQI) Global Score at 6 weeks.

  • Fractional Exhaled Nitric Oxide (FeNO)

    Change from baseline FeNO level (ppm) at 6 weeks.

  • Peak Nasal Inspiratory Flow (PNIF)

    Change from baseline PNIF (L/s) at 6 weeks.

  • Aerobic Fitness (Maximum oxygen consumption; VO2max)

    Change from baseline VO2max at 6 weeks.

Study Arms (3)

Circuit Breathing

EXPERIMENTAL
Other: Circuit Breathing Intervention

Diaphragmatic breathing

EXPERIMENTAL
Other: Diaphragmatic Breathing

Control group (Normal daily life)

NO INTERVENTION

Interventions

Participants will begin by breathing normally for 1 minute before starting diaphragmatic breathing. The diaphragmatic breathing exercise will consist of inhaling through the nose for 4 seconds and exhaling through the nose for 6 seconds, continuously for 10 minutes per set. Participants will rest for 1 minute between sets and complete a total of 3 sets.

Diaphragmatic breathing

The circuit breathing intervention consists of five stations: paper suction using a straw, blowing a toy pinwheel, incentive spirometry, balloon blowing, and weighted diaphragmatic breathing. Participants will rest for 1 minute between stations.

Circuit Breathing

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male or female, aged 15-25 years.
  • Regular e-cigarette use for at least 6 months and current e-cigarette use, defined as using e-cigarettes at least 1 day per week or at least 10 puffs per day during the past 30 days.
  • No regular exercise during the 6 months prior to the study, defined as exercising fewer than 2 times per week.
  • Willing and able to cooperate, with no communication difficulties, and able to follow the instructor's instructions.
  • No history of heart disease or respiratory diseases, including asthma and chronic obstructive pulmonary disease (COPD).
  • No hypertension, or controlled hypertension with resting blood pressure not exceeding a systolic blood pressure of 140 mmHg and a diastolic blood pressure of 90 mmHg (Whelton et al., 2018).
  • Able to move independently without assistance from another person or the use of assistive devices.
  • Voluntarily agrees to participate in the study and is willing to sign the informed consent form.
  • For participants younger than 18 years, consent must also be obtained from a legally authorized representative or parent/guardian.

You may not qualify if:

  • An unforeseen circumstance prevents them from continuing participation in the study, such as an accidental injury or illness.
  • Unable to participate consistently in the breathing training program as required, defined as attending fewer than 80% of all scheduled training sessions. Participants must attend at least 15 sessions.
  • No longer willing to continue participating in the study.
  • Concurrent use of illegal drugs or other tobacco or nicotine products, such as conventional cigarettes, waterpipe tobacco (hookah), hand-rolled tobacco, e-cigarette liquids, or other nicotine-containing products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sports Science, Chulalongkorn University

Bangkok, Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

VapingSmoking CessationRespiratory Aspiration

Condition Hierarchy (Ancestors)

SmokingBehaviorHealth BehaviorRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Wannaporn Tongtako, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 13, 2026

First Posted

October 20, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

October 20, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations