Yoga-Based Breathing Exercises in a Salt-Cave Environment Versus a Standard Clinical Setting in Smokers (SPELEO-SMOKERS)
27 juillet 2026 mis à jour par: SEFA HAKTAN HATIK, Sinop University
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
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Iğdır, Turquie (Türkiye), 76900
- Tuzluca Rock Salt Mine Salt Therapy Center
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Salt-Cave Yoga-Based Breathing Exercise Group
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.
|
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.
|
|
Comparateur actif: Standard Clinical Setting Yoga-Based Breathing Exercise Group
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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Week 6
Délai: 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
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Baseline, week 3, and week 6; primary endpoint at week 6
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Forced Vital Capacity (FVC) From Baseline to Week 6
Délai: Baseline, week 3, and week 6
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FVC in liters, measured by pre-bronchodilator spirometry; baseline, week 3, and week 6.
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Baseline, week 3, and week 6
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Change in Peak Expiratory Flow (PEF) From Baseline to Week 6
Délai: Baseline, week 3, and week 6
|
PEF in L/s, measured by pre-bronchodilator spirometry; baseline, week 3, and week 6.
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Baseline, week 3, and week 6
|
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Change in FEV1/FVC Ratio From Baseline to Week 6
Délai: Baseline, week 3, and week 6
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FEV1/FVC expressed as a percentage; baseline, week 3, and week 6.
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Baseline, week 3, and week 6
|
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Change in 6-Minute Walk Distance From Baseline to Week 6
Délai: 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.
|
Baseline and week 6
|
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Change in Physical Activity Assessed by IPAQ-SF From Baseline to Week 6
Délai: Baseline and week 6
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Total physical activity expressed as MET-min/week using the standard IPAQ-SF scoring protocol; baseline and week 6.
|
Baseline and week 6
|
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Change in WHOQOL-BREF Scores From Baseline to Week 6
Délai: Baseline and week 6
|
Changes in General Health, Physical Health, Psychological, Social Relationships, and Environment scores; baseline and week 6.
|
Baseline and week 6
|
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Participants With Intervention-Related Adverse Events
Délai: 6-week study period
|
Number of participants experiencing intervention-related or spirometry-related adverse events during the 6-week study period.
|
6-week study period
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 décembre 2022
Achèvement primaire (Réel)
20 février 2023
Achèvement de l'étude (Réel)
28 février 2023
Dates d'inscription aux études
Première soumission
27 juillet 2026
Première soumission répondant aux critères de contrôle qualité
27 juillet 2026
Première publication (Réel)
30 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
30 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SPELEO-SMOKERS-2022
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Individual participant data will not be shared with external researchers.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .