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

NCT07737587 | Completed

• 1 other identifier: SPELEO-SMOKERS-2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Smoking; Respiratory Function

Keywords

Smoking; Speleotherapy; Salt cave; Spirometry; Yoga-based breathing exercise; 6-minute walk test; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, week 3, and week 6; primary endpoint at week 6

Secondary Outcomes (7)

• 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

Study Arms (2)

Salt-Cave Yoga-Based Breathing Exercise Group

EXPERIMENTAL

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

Standard Clinical Setting Yoga-Based Breathing Exercise Group

ACTIVE COMPARATOR

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

Interventions

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.

Salt-Cave Yoga-Based Breathing Exercise Group

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.

Standard Clinical Setting Yoga-Based Breathing Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sinop University: lead

Study Sites (1)

Tuzluca Rock Salt Mine Salt Therapy Center

Iğdır, 76900, Turkey (Türkiye)

Location

Related Publications (4)

• Kaminsky DA, Guntupalli KK, Lippmann J, Burns SM, Brock MA, Skelly J, DeSarno M, Pecott-Grimm H, Mohsin A, LaRock-McMahon C, Warren P, Whitney MC, Hanania NA. Effect of Yoga Breathing (Pranayama) on Exercise Tolerance in Patients with Chronic Obstructive Pulmonary Disease: A Randomized, Controlled Trial. J Altern Complement Med. 2017 Sep;23(9):696-704. doi: 10.1089/acm.2017.0102. Epub 2017 Jul 17.

  PMID: 28714735 RESULT

• Dinesh T, Gaur G, Sharma V, Madanmohan T, Harichandra Kumar K, Bhavanani A. Comparative effect of 12 weeks of slow and fast pranayama training on pulmonary function in young, healthy volunteers: A randomized controlled trial. Int J Yoga. 2015 Jan;8(1):22-6. doi: 10.4103/0973-6131.146051.

  PMID: 25558130 RESULT

• Rashleigh R, Smith SM, Roberts NJ. A review of halotherapy for chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2014 Feb 21;9:239-46. doi: 10.2147/COPD.S57511. eCollection 2014.

  PMID: 24591823 RESULT

• Freidl J, Huber D, Braunschmid H, Romodow C, Pichler C, Weisbock-Erdheim R, Mayr M, Hartl A. Winter Exercise and Speleotherapy for Allergy and Asthma: A Randomized Controlled Clinical Trial. J Clin Med. 2020 Oct 15;9(10):3311. doi: 10.3390/jcm9103311.

  PMID: 33076411 RESULT

MeSH Terms

Conditions

Tobacco Smoking; Respiratory Aspiration; Smoking

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst., Prof

Model Details: 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.

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start: December 1, 2022
• Primary Completion: February 20, 2023
• Study Completion: February 28, 2023
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)