Respiratory Function, Tobacco Smoking
Conditions
Keywords
Smoking, Speleotherapy, Salt cave, Spirometry, Yoga-based breathing exercise, 6-minute walk test, Quality of life
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALYoga-Based Breathing Exercise Program in a Salt-Cave Environment
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.
BEHAVIORALYoga-Based Breathing Exercise Program in a Standard Clinical 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.
Sponsors
Sinop University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participant and care-provider blinding was not feasible because the intervention settings were clearly distinguishable. Statistical analyses were performed using coded group labels (A/B).
Intervention model description
Participants were randomized in a 1:1 ratio and remained in their assigned group throughout the 6-week intervention. Both groups received the same breathing exercise program; the planned difference was the intervention setting.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Week 6 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Forced Vital Capacity (FVC) From Baseline to Week 6 | Baseline, week 3, and week 6 | FVC in liters, measured by pre-bronchodilator spirometry; baseline, week 3, and week 6. |
| Change in Peak Expiratory Flow (PEF) From Baseline to Week 6 | Baseline, week 3, and week 6 | PEF in L/s, measured by pre-bronchodilator spirometry; baseline, week 3, and week 6. |
| Change in FEV1/FVC Ratio From Baseline to Week 6 | Baseline, week 3, and week 6 | FEV1/FVC expressed as a percentage; baseline, week 3, and week 6. |
| Change in 6-Minute Walk Distance From Baseline to Week 6 | 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. |
| Change in Physical Activity Assessed by IPAQ-SF From Baseline to Week 6 | Baseline and week 6 | Total physical activity expressed as MET-min/week using the standard IPAQ-SF scoring protocol; baseline and week 6. |
| Change in WHOQOL-BREF Scores From Baseline to Week 6 | Baseline and week 6 | Changes in General Health, Physical Health, Psychological, Social Relationships, and Environment scores; baseline and week 6. |
| Participants With Intervention-Related Adverse Events | 6-week study period | Number of participants experiencing intervention-related or spirometry-related adverse events during the 6-week study period. |
Countries
Turkey (Türkiye)
Outcome results
None listed