An interventional study of Yoga-Based Breathing Exercise Program in a Salt-Cave Environment and Yoga-Based Breathing Exercise Program in a Standard Clinical Setting in Tobacco Smoking and Respiratory Function, sponsored by Sinop University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Sinop University · Not applicable, Interventional, and Treatment
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.
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.
68 studies on the registry are indexed under Tobacco Smoking; 26 are open to participants now.
This study's enrollment of 60 is below the median of 111 across 60 interventional studies indexed under Tobacco Smoking.
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Exclusion Criteria:
Withdrawal Criteria
Participants completed the physiotherapist-supervised yoga-based breathing exercise program at the Tuzluca Salt Therapy Center for 6 weeks, twice weekly. The program content, session duration, frequency, and supervision were identical to those of the comparator group; the planned between-group difference was the intervention setting.
Behavioral: Yoga-Based Breathing Exercise Program in a Salt-Cave Environment
Participants completed the same physiotherapist-supervised yoga-based breathing exercise program at the Iğdır Fizyodinamik Wellness Center for 6 weeks, twice weekly. The program content, session duration, frequency, and supervision were identical to those of the experimental group.
Behavioral: Yoga-Based Breathing Exercise Program in a Standard Clinical Setting
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.
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.
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to 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
Time frame: Baseline, week 3, and week 6; primary endpoint at week 6
Change in Forced Vital Capacity (FVC) From Baseline to Week 6
FVC in liters, measured by pre-bronchodilator spirometry; baseline, week 3, and week 6.
Time frame: Baseline, week 3, and week 6
Change in Peak Expiratory Flow (PEF) From Baseline to Week 6
PEF in L/s, measured by pre-bronchodilator spirometry; baseline, week 3, and week 6.
Time frame: Baseline, week 3, and week 6
Change in FEV1/FVC Ratio From Baseline to Week 6
FEV1/FVC expressed as a percentage; baseline, week 3, and week 6.
Time frame: Baseline, week 3, and week 6
Change in 6-Minute Walk Distance From Baseline to 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.
Time frame: Baseline and week 6
Change in Physical Activity Assessed by IPAQ-SF From Baseline to Week 6
Total physical activity expressed as MET-min/week using the standard IPAQ-SF scoring protocol; baseline and week 6.
Time frame: Baseline and week 6
Change in WHOQOL-BREF Scores From Baseline to Week 6
Changes in General Health, Physical Health, Psychological, Social Relationships, and Environment scores; baseline and week 6.
Time frame: Baseline and week 6
Participants With Intervention-Related Adverse Events
Number of participants experiencing intervention-related or spirometry-related adverse events during the 6-week study period.
Time frame: 6-week study period
Plan to share: No — Individual participant data will not be shared with external researchers.
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