SmokingNCT05810298
Effects of Yoga on Pulmonary Parameters, Posture, Body Awareness and Quality of Life Among Chronic Smokers
A study testing Asana Practice, Pranayam Practice (Rhythmic regulated breathing) and Smoking Education Program in people with Smoking, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effects of practicing pranayam (voluntary regulated breathing) and yogasana (standing poses of yoga) with subject education on vital capacity, respiratory muscle strength, spinal flexibility, body awareness, quality of life and nicotine dependence of smokers and non-smokers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Asana Practice, Pranayam Practice (Rhythmic regulated breathing) and Smoking Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Dec 2022to 23 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntary participation in research
- Young healthy subjects who were aged between 18-60 years with or without daily cigarette smoking habit
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fizyoram Physiotherapy Counseling Center
Istanbul, 34517
About this study
Official title: 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
The aim of this study is to examine the effects of practicing pranayam (voluntary regulated breathing) and yogasana (standing poses of yoga) with subject education on vital capacity, respiratory muscle strength, spinal flexibility, body awareness, quality of life and nicotine dependence of smokers and non-smokers.
Read the 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.
- Conditions
- Smoking
- Being tested
- Asana Practice, Pranayam Practice (Rhythmic regulated breathing), Smoking Education Program
- Keywords
- Yoga, Pranayam, Breathing exercise, Asana, Smoking, Spine health, Spinal stretches
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asana PracticeOther
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.
Pranayam Practice (Rhythmic regulated breathing)Other
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.
Smoking Education ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Smokers Group | Experimental | Education about smoking
Asana practice (Only standing yoga poses with rhytmic breathing)
Pranayam (Rhytmic regulated breathing) Receives: Other: Asana Practice; Other: Pranayam Practice (Rhythmic regulated breathing); Behavioral: Smoking Education Program |
| Control Group | Active comparator | Asana practice (Only standing yoga poses with rhytmic breathing)
Pranayam (Rhytmic regulated breathing) Receives: Other: Asana Practice; Other: Pranayam Practice (Rhythmic regulated breathing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fagerström Test for Nicotine Dependence
Nicotine dependence will be evaluated with this test
Measured: 4 weeks
Thoracic Spine Range of Motion
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.
Measured: 4 weeks
Pulmonary Function Tests
Medical International Research Spirodoc® Spiro spirometry will be used to evaluate pulmonary functions of volunteers.
Measured: 4 weeks
Respiratory Muscle Strength
The Micro Medical Micro RPM respiratory pressure meter will be used to evaluate respiratory muscle strength.
Measured: 4 weeks
New York Posture Rating Chart
Different parts of body will be screened by the physiotherapist and observation data will be used to evaluate volunteers posture.
Measured: 4 weeks
World Health Organization Quality of Life Assesment (WHOQOL-BREF)
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.
Measured: 4 weeks
Body Awareness Questionnaire(BAQ)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start22 Dec 2022
- Primary completion2 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810298
- Sponsor's protocol ID
- CanerÖ
- Status last verified
- Mar 2023
- First submitted
- 30 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05810298
- Acronym / sponsor ID
- CanerÖ
- Conditions
- Smoking
- Keywords
- Yoga, Pranayam, Breathing exercise, Asana, Smoking, Spine health, Spinal stretches
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to examine the effects of practicing pranayam (voluntary regulated breathing) and yogasana (standing poses of yoga) with subject education on vital capacity, respiratory muscle strength, spinal flexibility, body awareness, quality of life and nicotine dependence of smokers and non-smokers.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smokers Group | Experimental | Other: Asana Practice, Other: Pranayam Practice (Rhythmic regulated breathing), Behavioral: Smoking Education ProgramEducation about smoking Asana practice (Only standing yoga poses with rhytmic breathing) Pranayam (Rhytmic regulated breathing) |
| Control Group | Active comparator | Other: Asana Practice, Other: Pranayam Practice (Rhythmic regulated breathing)Asana practice (Only standing yoga poses with rhytmic breathing) Pranayam (Rhytmic regulated breathing) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Voluntary participation in research
- Young healthy subjects who were aged between 18-60 years with or without daily cigarette smoking habit
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asana PracticeYogasana 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. | Other | Control Group, Smokers Group |
| Pranayam Practice (Rhythmic regulated breathing)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. | Other | Control Group, Smokers Group |
| Smoking Education ProgramThe 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. | Behavioural | Smokers Group |
Primary outcome
Fagerström Test for Nicotine Dependence
Time frame: 4 weeks
Nicotine dependence will be evaluated with this test
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.
Pulmonary Function Tests
Time frame: 4 weeks
Medical International Research Spirodoc® Spiro spirometry will be used to evaluate pulmonary functions of volunteers.
Respiratory Muscle Strength
Time frame: 4 weeks
The Micro Medical Micro RPM respiratory pressure meter will be used to evaluate respiratory muscle strength.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asana Practice, Pranayam Practice (Rhythmic regulated breathing) and Smoking Education Program in people with Smoking, run by Yeditepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fagerström Test for Nicotine Dependence (time frame: 4 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.