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Yoga-Based Breathing Exercises in a Salt-Cave Environment Versus a Standard Clinical Setting in Smokers (SPELEO-SMOKERS)

27. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Türkei (türkiye)
      • Iğdır, Türkei (türkiye), 76900
        • Tuzluca Rock Salt Mine Salt Therapy Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: Yoga-Based Breathing Exercise Program in a Salt-Cave Environment
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.
Aktiver 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.
Verhalten: Yoga-Based Breathing Exercise Program in a Standard Clinical Setting
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Week 6
Zeitfenster: 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
Baseline, week 3, and week 6; primary endpoint at week 6

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Forced Vital Capacity (FVC) From Baseline to Week 6
Zeitfenster: Baseline, week 3, and week 6
FVC in liters, measured by pre-bronchodilator spirometry; baseline, week 3, and week 6.
Baseline, week 3, and week 6
Change in Peak Expiratory Flow (PEF) From Baseline to Week 6
Zeitfenster: Baseline, week 3, and week 6
PEF in L/s, measured by pre-bronchodilator spirometry; baseline, week 3, and week 6.
Baseline, week 3, and week 6
Change in FEV1/FVC Ratio From Baseline to Week 6
Zeitfenster: Baseline, week 3, and week 6
FEV1/FVC expressed as a percentage; baseline, week 3, and week 6.
Baseline, week 3, and week 6
Change in 6-Minute Walk Distance From Baseline to Week 6
Zeitfenster: 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
Change in Physical Activity Assessed by IPAQ-SF From Baseline to Week 6
Zeitfenster: Baseline and week 6
Total physical activity expressed as MET-min/week using the standard IPAQ-SF scoring protocol; baseline and week 6.
Baseline and week 6
Change in WHOQOL-BREF Scores From Baseline to Week 6
Zeitfenster: Baseline and week 6
Changes in General Health, Physical Health, Psychological, Social Relationships, and Environment scores; baseline and week 6.
Baseline and week 6
Participants With Intervention-Related Adverse Events
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Sinop University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Dezember 2022

Primärer Abschluss (Tatsächlich)

20. Februar 2023

Studienabschluss (Tatsächlich)

28. Februar 2023

Studienanmeldedaten

Zuerst eingereicht

27. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Juli 2026

Zuerst gepostet (Tatsächlich)

30. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SPELEO-SMOKERS-2022

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be shared with external researchers.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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