Yoga-Based Breathing Exercises Performed in a Salt-Cave Environment Versus a Standard Clinical Setting in Smokers: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Week 6
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 65 years
- •Voluntary participation and written informed consent
- •Ability to ambulate and cooperate with assessments
- •Daily smoking for at least the previous 12 months
- •Body mass index below 30 kg/m²
排除标准
- •Adults aged 18 to 65 years
- •Voluntary participation and written informed consent
- •Ability to ambulate and cooperate with assessments
- •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
结局指标
主要结局
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Week 6
时间窗: 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
次要结局
- Change in Forced Vital Capacity (FVC) From Baseline to Week 6(Baseline, week 3, and week 6)
- Change in Peak Expiratory Flow (PEF) From Baseline to Week 6(Baseline, week 3, and week 6)
- Change in FEV1/FVC Ratio From Baseline to Week 6(Baseline, week 3, and week 6)
- Change in 6-Minute Walk Distance From Baseline to Week 6(Baseline and week 6)
- Change in Physical Activity Assessed by IPAQ-SF From Baseline to Week 6(Baseline and week 6)
- Change in WHOQOL-BREF Scores From Baseline to Week 6(Baseline and week 6)
- Participants With Intervention-Related Adverse Events(6-week study period)
研究者
SEFA HAKTAN HATIK
Asst., Prof
Sinop University