Yoga-Based Breathing Exercises in a Salt-Cave Environment Versus a Standard Clinical Setting in Smokers (SPELEO-SMOKERS)
2026년 7월 27일 업데이트: 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.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (실제)
등록
60
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Iğdır, 터키 (Türkiye), 76900
- Tuzluca Rock Salt Mine Salt Therapy Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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.
|
|
활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Week 6
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Forced Vital Capacity (FVC) From Baseline to Week 6
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2022년 12월 1일
기본 완료 (실제)
기본 완료
2023년 2월 20일
연구 완료 (실제)
연구 완료
2023년 2월 28일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 27일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 27일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 30일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 27일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- SPELEO-SMOKERS-2022
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Individual participant data will not be shared with external researchers.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .