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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05810298
Other study ID # CanerÖ
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 22, 2022
Est. completion date March 23, 2023

Study information

Verified date March 2023
Source Yeditepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date March 23, 2023
Est. primary completion date March 2, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Asana Practice
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)
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.
Behavioral:
Smoking Education Program
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.

Locations

Country Name City State
Turkey Fizyoram Physiotherapy Counseling Center Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Yeditepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fagerström Test for Nicotine Dependence Nicotine dependence will be evaluated with this test 4 weeks
Primary 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. 4 weeks
Primary Pulmonary Function Tests Medical International Research Spirodoc® Spiro spirometry will be used to evaluate pulmonary functions of volunteers. 4 weeks
Primary Respiratory Muscle Strength The Micro Medical Micro RPM respiratory pressure meter will be used to evaluate respiratory muscle strength. 4 weeks
Primary 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. 4 weeks
Primary 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. 4 weeks
Primary 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. 4 weeks
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