Yoga-Based Breathing Exercises in a Salt-Cave Environment Versus a Standard Clinical Setting in Smokers (SPELEO-SMOKERS)
27 lipca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
60
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Iğdır, Turcja (Türkiye), 76900
- Tuzluca Rock Salt Mine Salt Therapy Center
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
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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.
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Aktywny komparator: 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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Week 6
Ramy czasowe: Baseline, week 3, and week 6; primary endpoint at week 6
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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
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Forced Vital Capacity (FVC) From Baseline to Week 6
Ramy czasowe: 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
Ramy czasowe: Baseline, week 3, and week 6
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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
Ramy czasowe: 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
Ramy czasowe: Baseline and week 6
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Distance walked in meters during the 6-minute walk test.
Two tests were administered and the longest distance was used; baseline and week 6.
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Baseline and week 6
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Change in Physical Activity Assessed by IPAQ-SF From Baseline to Week 6
Ramy czasowe: 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.
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Baseline and week 6
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Change in WHOQOL-BREF Scores From Baseline to Week 6
Ramy czasowe: Baseline and week 6
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Changes in General Health, Physical Health, Psychological, Social Relationships, and Environment scores; baseline and week 6.
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Baseline and week 6
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Participants With Intervention-Related Adverse Events
Ramy czasowe: 6-week study period
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Number of participants experiencing intervention-related or spirometry-related adverse events during the 6-week study period.
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6-week study period
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 grudnia 2022
Zakończenie podstawowe (Rzeczywisty)
20 lutego 2023
Ukończenie studiów (Rzeczywisty)
28 lutego 2023
Daty rejestracji na studia
Pierwszy przesłany
27 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
27 lipca 2026
Pierwszy wysłany (Rzeczywisty)
30 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
30 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
27 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- SPELEO-SMOKERS-2022
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
Individual participant data will not be shared with external researchers.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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