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Tobacco SmokingSPELEO-SMOKERSNCT07737587

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

A study testing Yoga-Based Breathing Exercise Program in a Salt-Cave Environment and Yoga-Based Breathing Exercise Program in a Standard Clinical Setting in people with Tobacco Smoking and Respiratory Function, run by Sinop University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Tobacco Smoking, Respiratory Function
What is being tested?
Yoga-Based Breathing Exercise Program in a Salt-Cave Environment and Yoga-Based Breathing Exercise Program in a Standard Clinical Setting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2022to 28 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Withdrawal Criteria
  • Participant request to discontinue
  • Pregnancy or suspected pregnancy
  • Occurrence of a sports-related injury during assessments

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Tuzluca Rock Salt Mine Salt Therapy Center

    Iğdır, 76900

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Yoga-Based Breathing Exercise Program in a Salt-Cave Environment, Yoga-Based Breathing Exercise Program in a Standard Clinical Setting
Keywords
Smoking, Speleotherapy, Salt cave, Spirometry, Yoga-based breathing exercise, 6-minute walk test, Quality of life
Medical subject headings
Tobacco Smoking, Respiratory Aspiration, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yoga-Based Breathing Exercise Program in a Salt-Cave EnvironmentBehavioural

    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 SettingBehavioural

    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.

Study groups in NCT07737587
Study groupRoleWhat they receive
Salt-Cave Yoga-Based Breathing Exercise GroupExperimentalParticipants 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.
Receives: Behavioral: Yoga-Based Breathing Exercise Program in a Salt-Cave Environment
Standard Clinical Setting Yoga-Based Breathing Exercise GroupActive comparatorParticipants 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.
Receives: Behavioral: Yoga-Based Breathing Exercise Program in a Standard Clinical Setting

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (7)
  1. 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.

    Measured: Baseline, week 3, and week 6

  2. 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.

    Measured: Baseline, week 3, and week 6

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

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

    Measured: Baseline, week 3, and week 6

  4. 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.

    Measured: Baseline and week 6

  5. 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.

    Measured: Baseline and week 6

  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.

    Measured: Baseline and week 6

  7. Participants With Intervention-Related Adverse Events

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

    Measured: 6-week study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2026
  2. Study start1 Dec 2022
  3. Primary completion20 Feb 2023
  4. Study completion28 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07737587
Sponsor's protocol ID
SPELEO-SMOKERS-2022
Acronym
SPELEO-SMOKERS
Status last verified
Jul 2026
First submitted
27 Jul 2026
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared with external researchers.

Publications

  • 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.

    PubMed 28714735
  • 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.

    PubMed 25558130
  • 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.

    PubMed 24591823
  • 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.

    PubMed 33076411

Questions about this trial

What is this clinical trial studying?

A study testing Yoga-Based Breathing Exercise Program in a Salt-Cave Environment and Yoga-Based Breathing Exercise Program in a Standard Clinical Setting in people with Tobacco Smoking and Respiratory Function, run by Sinop University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07737587, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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