- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05810298
Effects of Yoga on Pulmonary Parameters, Posture, Body Awareness and Quality of Life Among Chronic Smokers
Effects of Pranayam (Voluntary Regulated Breathing) and Yogasana (Yoga Postures) on Posture, Pulmonary Parameters, Spine Flexibility, Body Awareness and Quality of Life Among Chronic Smokers
Study Overview
Status
Conditions
Detailed Description
When initial assesments will be completed, volunteers will be assigned to one of two possible sequences by their nicotine dependency. Smokers group (SG) or control group (CG).
All volunteers will receive an exercise program with Asana and Pranayam practices with the duration of 4 weeks.
All subjects will be assessed in terms of functional capacity, pulmonary functions, thoracic spine range of motion, postural analysis, respiratory muscle strength, body awareness, quality of life and nicotine dependence at the baseline and at the end of the study. Data will be collected from all the subjects at baseline and at the end of the study (4 weeks) by the same physiotherapist who also will supervise the exercise sessions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey, 34517
- Fizyoram Physiotherapy Counseling Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Voluntary participation in research
- Young healthy subjects who were aged between 18-60 years with or without daily cigarette smoking habit
Exclusion Criteria:
- Allergic disorders or respiratory disorders
- History of a major surgery in the last 2 years
- Neurological diseases
- Cardiovascular diseases which are contraindicates exercise
- Fractures or orthopedic problems in upper or lower extremities
- Systemic rheumatical diseases(Rheumatoid Arthritis, Ankylosing Spondilitis etc.)
Systemic diseases and respiratory disorders will be ruled out in the selected subjects by taking their detailed history and by their thorough clinical examination by the researcher.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Smokers Group
Education about smoking Asana practice (Only standing yoga poses with rhytmic breathing) Pranayam (Rhytmic regulated breathing) |
Yogasana training will be comprised of active movements when standing.
Spine and limbs stretches eccentrically respecting the movement patterns of body without pushing limits.
Transition in between poses will be synchronized with breathing pattern in zero resistance flow.
The exercises will be done 2 days a week online under the supervision of physiotherapist.
Total duration of standing poses training will last for 4 weeks.
Breathing exercises will be comprised of diaphragmatic breathing, holding the breath after inhaling deeply and exhaling passively or exhaling actively by contracting abdominal muscles and inhaling passively.
The exercises will be done 2 days a week online under the supervision of physiotherapist.
Total duration of breathing exercises will last for 4 weeks.
The aim of the education is to increase awareness of subjects who are chronical smokers.
The subject education will be performed at least once via face to face interview.
Education topics will be covered basic information about harmful effects of habitual smoking and how to reduce the side effects of nicotine withdrawal.
|
|
Active Comparator: Control Group
Asana practice (Only standing yoga poses with rhytmic breathing) Pranayam (Rhytmic regulated breathing) |
Yogasana training will be comprised of active movements when standing.
Spine and limbs stretches eccentrically respecting the movement patterns of body without pushing limits.
Transition in between poses will be synchronized with breathing pattern in zero resistance flow.
The exercises will be done 2 days a week online under the supervision of physiotherapist.
Total duration of standing poses training will last for 4 weeks.
Breathing exercises will be comprised of diaphragmatic breathing, holding the breath after inhaling deeply and exhaling passively or exhaling actively by contracting abdominal muscles and inhaling passively.
The exercises will be done 2 days a week online under the supervision of physiotherapist.
Total duration of breathing exercises will last for 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fagerström Test for Nicotine Dependence
Time Frame: 4 weeks
|
Nicotine dependence will be evaluated with this test
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4 weeks
|
|
Thoracic Spine Range of Motion
Time Frame: 4 weeks
|
Thoracic spinal elasticity will be evaluated with measuring rotational range of motion of T1-T2 spine using iPhone compass app.
A strong and significant correlation was found between the Universel Goniometer and the Compass app by Furness et al. (2018), demonstrating good concurrent validity.
|
4 weeks
|
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Pulmonary Function Tests
Time Frame: 4 weeks
|
Medical International Research Spirodoc® Spiro spirometry will be used to evaluate pulmonary functions of volunteers.
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4 weeks
|
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Respiratory Muscle Strength
Time Frame: 4 weeks
|
The Micro Medical Micro RPM respiratory pressure meter will be used to evaluate respiratory muscle strength.
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4 weeks
|
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New York Posture Rating Chart
Time Frame: 4 weeks
|
Different parts of body will be screened by the physiotherapist and observation data will be used to evaluate volunteers posture.
|
4 weeks
|
|
World Health Organization Quality of Life Assesment (WHOQOL-BREF)
Time Frame: 4 weeks
|
Turkish version of WHOQOL-BREF will be used in this study as given by WHO.
This questionnaire will be used to provide numerical data on Quality of Life assesments of the volunteers.
|
4 weeks
|
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Body Awareness Questionnaire(BAQ)
Time Frame: 4 weeks
|
Body Awareness Questionnaire(BAQ) will be used to provide numerical data on subjects body awareness.
A Turkish validity study of BAQ was performed by Karaca and it's valid as well as reliable.
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4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CanerÖ
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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