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Completed

NCT Number: NCT07737587

Yoga-Based Breathing Exercises in a Salt-Cave Environment Versus a Standard Clinical Setting in Smokers

This randomized controlled trial evaluated whether performing the same yoga-based breathing exercise program in a salt-cave environment produced different respiratory, functional, physical activity, and quality-of-life outcomes compared with the same program performed in a standard clinical setting in adult smokers. Sixty adult smokers were randomized to either a salt-cave group or a control group. Both groups received a physiotherapist-supervised yoga-based breathing exercise program for 6 weeks, twice weekly, in 50-minute sessions. The intervention content, frequency, duration, and physiotherapist supervision were identical in both groups; the only planned between-group difference was the intervention setting. Spirometric outcomes were assessed at baseline, week 3, and week 6. Functional exercise capacity, physical activity, and quality of life were assessed at baseline and week 6.

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Key information

Conditions

Tobacco Smoking Behavior Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Function Respiratory Tract Diseases Smoking Tobacco Use

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tuzluca Rock Salt Mine Salt Therapy Center

Iğdır, 76900, Turkey (Türkiye)

About this study

Eligible participants were adult daily smokers aged 18 to 65 years who had smoked for at least the previous 12 months. After baseline assessments, participants were randomized in a 1:1 ratio to the salt-cave group or the standard clinical setting group. Allocation was generated by an independent researcher and concealed using sequentially numbered, opaque, sealed envelopes. Both groups completed the same 6-week yoga-based breathing exercise program, delivered twice weekly under physiotherapist supervision. Each standardized session lasted approximately 50 minutes and included preparatory breathing control, diaphragmatic breathing, Suusi breathing, Kapalabhati, Ujjayi, Anuloma-Viloma/Nadi Shodhana, Bhastrika, Bhramari, Agni Sar, and relaxation. The salt-cave group received the program at the Tuzluca Salt Therapy Center, whereas the control group received the program in a standard private clinical setting. Spirometric parameters included forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), peak expiratory flow (PEF), and the FEV1/FVC ratio. Secondary assessments included the 6-minute walk test, the International Physical Activity Questionnaire-Short Form, and the World Health Organization Quality of Life-BREF. Participant and provider blinding was not feasible because the settings were visibly different. Statistical analysis was conducted using coded group labels.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 to 65 years
  • Voluntary participation and written informed consent
  • Ability to ambulate and cooperate with assessments
  • Literacy
  • Daily smoking for at least the previous 12 months
  • Body mass index below 30 kg/m²

Exclusion criteria

  • Adults aged 18 to 65 years
  • Voluntary participation and written informed consent
  • Ability to ambulate and cooperate with assessments
  • Literacy
  • Daily smoking for at least the previous 12 months
  • Body mass index below 30 kg/m²

Withdrawal Criteria

  • Participant request to discontinue
  • Pregnancy or suspected pregnancy
  • Occurrence of a sports-related injury during assessments

Treatment and study plan

Yoga-Based Breathing Exercise Program in a Salt-Cave Environment

Behavioral

Participants received a physiotherapist-supervised yoga-based breathing exercise program at the Tuzluca Salt Therapy Center. The intervention lasted 6 weeks and included two sessions per week, for a total of 12 sessions. Each standardized session lasted approximately 50 minutes and included preparatory breathing control, diaphragmatic breathing, Suusi breathing, Kapalabhati, Ujjayi, Anuloma-Viloma/Nadi Shodhana, Bhastrika, Bhramari, Agni Sar, and relaxation. The exercise content, session frequency, duration, and physiotherapist supervision were identical to those provided in the standard clinical setting group; the planned difference was the intervention setting.

Yoga-Based Breathing Exercise Program in a Standard Clinical Setting

Behavioral

Participants received the same physiotherapist-supervised yoga-based breathing exercise program in a standard clinical setting at the Iğdır Fizyodinamik Wellness Center. The intervention lasted 6 weeks and included two sessions per week, for a total of 12 sessions. Each standardized session lasted approximately 50 minutes and included preparatory breathing control, diaphragmatic breathing, Suusi breathing, Kapalabhati, Ujjayi, Anuloma-Viloma/Nadi Shodhana, Bhastrika, Bhramari, Agni Sar, and relaxation. The exercise content, session frequency, duration, and physiotherapist supervision were identical to those provided in the salt-cave group.

Primary outcomes

  1. Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Week 6

    Time frame: Baseline, week 3, and week 6; primary endpoint at week 6

    FEV1 was measured in liters using pre-bronchodilator spirometry. Participants performed three forced expiratory maneuvers under standardized instruction, and the best acceptable value was recorded. The primary comparison was the between-group difference in change from baseline to week 6. An interim measurement was also obtained at week 3

Secondary outcomes

  1. Change in Forced Vital Capacity (FVC) From Baseline to Week 6

    Time frame: Baseline, week 3, and week 6

    FVC in liters, measured by pre-bronchodilator spirometry; baseline, week 3, and week 6.

  2. Change in Peak Expiratory Flow (PEF) From Baseline to Week 6

    Time frame: Baseline, week 3, and week 6

    PEF in L/s, measured by pre-bronchodilator spirometry; baseline, week 3, and week 6.

  3. Change in FEV1/FVC Ratio From Baseline to Week 6

    Time frame: Baseline, week 3, and week 6

    FEV1/FVC expressed as a percentage; baseline, week 3, and week 6.

  4. Change in 6-Minute Walk Distance From Baseline to Week 6

    Time frame: Baseline and week 6

    Distance walked in meters during the 6-minute walk test. Two tests were administered and the longest distance was used; baseline and week 6.

  5. Change in Physical Activity Assessed by IPAQ-SF From Baseline to Week 6

    Time frame: Baseline and week 6

    Total physical activity expressed as MET-min/week using the standard IPAQ-SF scoring protocol; baseline and week 6.

  6. Change in WHOQOL-BREF Scores From Baseline to Week 6

    Time frame: Baseline and week 6

    Changes in General Health, Physical Health, Psychological, Social Relationships, and Environment scores; baseline and week 6.

  7. Participants With Intervention-Related Adverse Events

    Time frame: 6-week study period

    Number of participants experiencing intervention-related or spirometry-related adverse events during the 6-week study period.

Sponsors and collaborators

Lead sponsor

Sinop University

Other

Registry information

Official study title

Yoga-Based Breathing Exercises Performed in a Salt-Cave Environment Versus a Standard Clinical Setting in Smokers: A Randomized Controlled Trial

Acronym: SPELEO-SMOKERS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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