- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07488741
Comparison of the Effects of Different Chest Techniques on University Students With Smoking Addiction
Comparison of the Effects of Chest PNF Techniques and Chest Mobility Exercises on Respiratory Function, Chest Expansion, and Functional Capacity in University Students With Smoking Addiction: A Single-Blind Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Smoking, due to the various chemical substances it contains, constitutes a risk factor for many diseases, primarily heart and lung diseases. It has been reported that smoking rates are higher among students living in underdeveloped or developing countries. Most users start smoking at a young age. Figures show that 31.9% of individuals aged 15-24 in Türkiye use tobacco (CDC, 2016). While there is no national study on universities across Turkey, studies report smoking prevalence rates ranging from 20.6% to 43.6%. Due to harmful substances like nicotine, smoking can lead to COPD, atherosclerosis, and other respiratory diseases. Furthermore, individuals who smoke are more likely to stop exercising due to fatigue, dyspnea, and pain. Smoking negatively impacts lung capacity, reducing FVC, FEV1, and FEV1/FVC volumes while increasing RV volume. Proprioceptive neuromuscular facilitation (PNF) techniques targeting the chest area are used in various populations to enhance respiratory muscle function and improve respiratory parameters. Improvements in range of motion, flexibility, and thoracic congruence can be achieved through both active and passive chest mobility exercises. Lengthening of the intercostal muscles allows for more efficient contraction. The underlying mechanism of chest mobility exercises involves increasing intercostal muscle length, facilitating effective muscle contraction. Facilitating the downward movement of the diaphragm and increasing the forward and backward movement capability of both the superior and inferior costal muscles improves the biomechanics of chest movement. Intercostal muscle rotation is best achieved by fully retracting the chest wall. Chest PNF technique has only recently begun to be used in smokers. Studies have shown that chest PNF techniques positively improve lung function and chest expansion in male smokers. A study conducted on female smokers showed that chest PNF technique followed by breathing exercises regulated blood pressure.
Objective: The aim of study is to compare the effectiveness of chest PNF techniques and chest mobility exercises in university students who are smokers. Study Hypotheses:
H0: There is no difference between chest PNF techniques and chest mobility exercises in respiratory functions, chest expansion, and functional capacity in university students who are smokers.
H1: There is a difference between chest PNF techniques and chest mobility exercises in respiratory functions, chest expansion, and functional capacity in university students who are smokers.
H2: The effects of chest PNF techniques on respiratory functions, chest expansion, and functional capacity in university students who are smokers are not different from the control group.
H3: The effects of chest PNF techniques on respiratory functions, chest expansion, and functional capacity in university students who are smokers are different from the control group.
H4: The effects of chest mobility exercises on respiratory functions, chest expansion, and functional capacity in university students who are smokers are not different from the control group. H5: The effects of chest mobility exercises on respiratory function, chest expansion, and functional capacity differ in university students who are smokers compared to the control group.
Scope: This research is a prospective experimental study. The study will be conducted on 30 individuals who meet the inclusion criteria. The study population will be formed through announcement and invitation, and interventions will be implemented at the Yalova University Physiotherapy and Rehabilitation Application and Research Center.
Method: In calculating the minimum sample size for the study, FEV1 was used as the primary variable, and the effect size was calculated by considering data from a previous study in the literature that investigated the effectiveness of exercise in smoking addiction. Using the GPower 3.1 program, with a 95% confidence interval, 90% power, and Cohen's f=0.7797218 effect size, the calculation revealed that the minimum sample size for the study should be 27 individuals. Considering participant dropout and data loss, 10% more participants will be included. Accordingly, the study is planned to be conducted with 30 people. Participants will be included in the study through invitation and announcement. The study will be conducted with individuals who meet the inclusion criteria. Participants will be randomized into 3 groups: Chest PNF Techniques, Chest Mobility Exercises, and Control. This randomization will be performed using randomizer.org, an open-access randomization site. Both groups will be evaluated during the initial interview, and after completing an informed consent form, the participants will be informed about the process. The study will be conducted on individuals with smoking addiction. The inclusion criteria include a Fagerström Nicotine Dependence Questionnaire score of ≥4, which is considered indicative of nicotine dependence. Turkish validity and reliability were established by Uysal et al.
Data Collection Tools:
Demographic Information, Pulmonary Function Test Measurements are taken with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) while the person is in a seated position, Dyspnea Assessment: Modified Medical Research Council, Functional Capacity Assessment: Six-Minute Walk Test - 6MWT, Depression Assessment: The Beck Depression Inventory (BDI), Quality of Life Assessment: Patients' quality of life will be assessed using the Short Form-36 (SF-36), Chest Expansion: Chest expansion was assessed by measuring the circumference of the chest wall at maximum inspiration and maximum expiration, Fatigue: Patients' fatigue was assessed using the Turkish adaptation of the Fatigue Severity Scale, Physical Activity Level Assessment: International Physical Activity Questionnaire Short Form - IPAQS, Harvard Step Test: This test, used to measure cardiopulmonary endurance and physical fitness, involves individuals climbing and descending steps for 5 minutes.
Group Exercise Programs:
The Chest PNF Techniques and Chest Mobility Exercises group will receive treatment for a total of 6 weeks, with 3 sessions of 30 minutes per week. The control group will not receive any treatment.
Chest PNF Techniques Group: Chest PNF exercises will be performed in supine, side, and prone positions. The combined isotonic contractions technique will be used to improve respiratory control. Each technique will be performed for 12 repetitions. In all positions, the patient is first asked to exhale. Pressure and stretching are applied in the opposite direction of the movement. While the patient inhales, the physiotherapist controls the resistance to allow movement. If necessary, more resistance is applied to stronger areas to distribute the force to weaker areas. Supine position: Both hands are placed on the sternum and pressure is applied obliquely downwards. The hands are placed parallel and diagonally on the lateral chest wall, over the lower ribs. To focus on the upper chest area, the hands are similarly placed on the pectoral muscles.
Side-lying position: Both hands are placed parallel and diagonally on the lateral chest wall, over the lower ribs. This position is beneficial in distributing the force to the upper chest movement as it will provide resistance to the lower chest movement.
Prone position: Hands are placed parallel and diagonally on the lower ribs. In the forearm support position, one hand is placed on the sternum and the other hand on the intercostal region Chest Mobility Exercises Group: Chest mobility exercises will be performed. The exercises will be performed in combination with diaphragmatic breathing exercises, with 18-20 repetitions and 30-second breaks.
Chest rotation: The person is in a supine position. They extend their arms into an inverted T position. The physiotherapist places their hands on the underside of the rib cage and applies stress in the opposite direction.
Passive lateral flexion in side lying position: The person is positioned in a side lying position with their arms hanging down from the stretcher, supported by a pillow. The therapist performs passive flexion of the rib cage from the head to the left and right sides, with slight overextension in the final range.
Thoracic facet joint mobilization in supine position: The physiotherapist places one hand on the person's thoracic region and the other on the chest, and performs mobilization with the person lying supine with their arms crossed in front.
Trunk rotation in sitting position: The physiotherapist stands behind the person in a sitting position. They actively and passively rotate the trunk on both sides.
Arm movement in front of the chest while sitting: While sitting, the person raises their arms. While exhaling, they raise their arms above their head, then slowly lower them while inhaling. Cat-camel exercise: While in a crawling position, inhale, arch your back, and bring your head forward. Then, exhale, lower your back towards the ground and extend your head backward.
Pectoral stretch: With elbows bent and hands clasped behind the neck, hold the shoulder in abduction and stretch the pectoralis major muscle. Breathe diaphragmatically through the nose for 4 seconds and exhale through the mouth for 6 seconds. Encourage chest opening while inhaling.
Chest movement in crawling position: While in a crawling position, try to bring one hand towards the opposite knee, return to the starting position, rotate the trunk, and perform upper extremity flexion and abduction. Repeat for the opposite side.
Control Group: No intervention will be performed. Statistical Analysis The data obtained in the study will be loaded into the SPSS 26.0 software package and analyzed. Numerical data will be presented as mean and standard deviation; categorical data will be presented as number and percentage. Normality will be analyzed using the Shapiro-Wilks test. For within-group comparisons between pre-tests and post-tests, a paired t-test will be used if the assumptions of normal distribution are met; otherwise, the Wilcoxon signed-rank test will be used. For between-group comparisons, a one-way ANOVA test and the Tukey test (post-hoc test) will be used if the assumptions of normal distribution are met; otherwise, the Kruskal-Wallis test and the Bonferroni correction (post-hoc test) will be applied. The significance level will be set at p<0.05.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gözde ARICA, MSc
- Phone Number: +905318893236
- Email: gozde.arica@yalova.edu.tr
Study Contact Backup
- Name: Büşra KAYABINAR, PhD
- Phone Number: +905553156871
- Email: busra.kayabinar@yalova.edu.tr
Study Locations
-
-
Yalova
-
Yalova, Yalova, Turkey (Türkiye)
- Recruiting
- Yalova University
-
Contact:
- Gözde ARICA, MSc
- Phone Number: 05318893236
- Email: gozde.arica@yalova.edu.tr
-
Sub-Investigator:
- Gözde ARICA, MSc
-
Contact:
- Büşra KAYABINAR, PhD
- Phone Number: +905553156871
- Email: busra.kayabinar@yalova.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age of 18-24 years
- Fagerström Nicotine Dependence Questionnaire score ≥4
- Smoking for at least 2 years
- Daily smoking ≥5 cigarettes and at least 90 pack-years. Stable condition (no acute respiratory infection in the last 4 weeks).
- FEV1 ≥80%
- Voluntary participation in the study
- No orthopedic or neurological problems that would prevent participation in exercise
Exclusion Criteria:
- Cardiac event or lung surgery in the last 6 months
- Respiratory problems such as COPD, asthma
- Orthopedic and neurological problems
- Termination of volunteering
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chest PNF Techniques Group
Chest PNF exercises will be performed in supine, side, and prone positions.
Each technique will be performed 12 times.
|
The combined isotonic contraction technique will be used to improve respiratory control.
In all positions, the patient is asked to exhale first.
Pressure and stretching are applied in the opposite direction of the movement.
As the patient inhales, resistance is controlled.
Supine position: Both hands are placed on the sternum and oblique downward pressure is applied.
The hands are placed parallel and diagonally along the lateral chest wall, above the lower ribs.
To focus on the upper chest region, the hands are similarly placed on the pectoral muscles.
Side-lying position: Both hands are placed parallel and diagonally along the lateral chest wall above the lower ribs.
This position is beneficial to resist chest movement in the lower region and thus distribute the force to chest movement in the upper region.
Prone position: The hands are placed parallel and diagonally along the lower ribs.
In the forearm position, one hand is placed on the sternum and the other on the intercostal region
|
|
Experimental: Chest Mobility Exercises Group
Chest mobility exercises will be performed.
The exercises will be done in combination with diaphragmatic breathing exercises, consisting of 18-20 repetitions with 30-second breaks.
|
Chest rotation, Passive lateral flexion while lying on the side, Mobilization of the thoracic facet joint while lying on the back, Trunk rotation in sitting position, Moving the arm in front of the chest while sitting, Cat-camel exercise, Pectoral stretch, Chest mobility in crawling position.
|
|
No Intervention: Control
No action will be taken.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dyspnea Assessment
Time Frame: Baseline and through study completion, an average of 6 weeks
|
Modified Medical Research Council -mMRC: The mMRC used for dyspnea assessment consists of five stages.
Stage 0 represents mild dyspnea, and Stage 4 represents severe dyspnea (Bestall et al., 1999).
|
Baseline and through study completion, an average of 6 weeks
|
|
Pulmonary Function Testing
Time Frame: Baseline and through study completion, an average of 6 weeks
|
Measurements are taken with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) while the patient is in a seated position.
Forced expiratory volume in one second (FEV1) is measured (Miller et al., 2005).
|
Baseline and through study completion, an average of 6 weeks
|
|
Pulmonary Function Testing
Time Frame: Baseline and through study completion, an average of 6 weeks
|
Measurements are taken with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) while the patient is in a seated position.
Forced vital capacity (FVC) is measured (Miller et al., 2005).
|
Baseline and through study completion, an average of 6 weeks
|
|
Pulmonary Function Testing
Time Frame: Baseline and through study completion, an average of 6 weeks
|
Measurements are taken with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) while the patient is in a seated position.
The ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC) is measured (Miller et al., 2005).
|
Baseline and through study completion, an average of 6 weeks
|
|
Pulmonary Function Testing
Time Frame: Baseline and through study completion, an average of 6 weeks
|
Measurements are made with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) with the patient in a sitting position.
Peak expiratory flow rate (PEF) are measured (Miller et al., 2005).
|
Baseline and through study completion, an average of 6 weeks
|
|
Pulmonary Function Testing
Time Frame: Baseline and through study completion, an average of 6 weeks
|
Measurements are made with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) with the patient in a sitting position.
Flow rate at 25-75% of forced vital capacity (FEF 25-75%) are measured (Miller et al., 2005)
|
Baseline and through study completion, an average of 6 weeks
|
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Pulmonary Function Testing
Time Frame: Baseline and through study completion, an average of 6 weeks
|
Measurements are made with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) with the patient in a sitting position.
Vital capacity (VC) are measured (Miller et al., 2005).
|
Baseline and through study completion, an average of 6 weeks
|
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Respiratory Muscle Strength Measurement
Time Frame: Baseline and through study completion, an average of 6 weeks
|
Maximal inspiratory pressure measurements (MIP) will be taken.
For the MIP measurement, the participant sits in a chair and, with a nose clip attached, is asked to take a maximum inspiration through the mouth for 1-3 seconds (Neder et al., 1999)
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Baseline and through study completion, an average of 6 weeks
|
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Respiratory Muscle Strength Measurement
Time Frame: Baseline and through study completion, an average of 6 weeks
|
Maximal expiratory pressure measurements (MEP) will be taken.
For the MEP measurement, the participant is asked to take a maximum inspiration and then a maximum expiration for 1-3 seconds.
After performing both measurements three times, the best reading is recorded (Neder et al., 1999).
|
Baseline and through study completion, an average of 6 weeks
|
|
Exercise Capacity Assessment
Time Frame: Baseline and through study completion, an average of 6 weeks
|
Six-Minute Walk Test - 6MWT: The six-minute walk test is one of the most frequently used field tests in clinical settings due to its practicality and low cost, assessing submaximal functional capacity.
The test is conducted in a 30-meter corridor.
After being informed about the test, the participant is asked to walk in a marked area in the corridor for six minutes, and the total distance is recorded.
It is recommended that it be performed three times at regular intervals throughout the day, and the best distance recorded.
The patient may stop and rest at any time and use assistive devices if available.
Blood pressure, heart rate, oxygen saturation, fatigue, and dyspnea are measured before and after the test.
In individuals with COPD, a walk of <350 meters is associated with lower exercise capacity and increased mortality risk (Ceylan, 2014).
A 6-minute walk will result in a report calculating the total distance walked in meters.
|
Baseline and through study completion, an average of 6 weeks
|
|
Depression Assessment (Beck Depression Inventory-BDI)
Time Frame: Baseline and through study completion, an average of 6 weeks
|
The BDI is a scale used to assess depression.
It consists of 21 items, each with four options.
The scale has a scoring system of 0-3.
The lowest score a participant can receive on this scale is 0 and the highest is 63.
Higher scores indicate increasing levels of depression.
Total scores are divided into 4 groups: 0-9 points: "minimal depression," 10-16 points: "mild depression," 17-29 points: "moderate depression," and 30 points and above: "severe depression."
The Turkish reliability study of this scale was conducted by Hisli in 1988 (Hisli, 1989).
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Baseline and through study completion, an average of 6 weeks
|
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Physical Activity Level Assessment
Time Frame: Baseline and through study completion, an average of 6 weeks
|
Short Form of the International Physical Activity Questionnaire-IPAQ-SF: This questionnaire, whose validity and reliability in Turkish were developed by Sağlam et al., consists of 7 questions.
It asks about vigorous and moderate physical activities, including walking and sitting activities, performed within the last week, on how many days per week and for how long.
Sitting activity is not included in the scoring section (Sağlam et al., 2010).
MET values of the activities were used as 8 METs for vigorous physical activities, 4 METs for moderate physical activities, and 3.3 METs for walking, and the total score was recorded as MET-min/week.
The total duration (minutes) and frequency (days) of each are required for score calculation.
The MET score is obtained by multiplying the MET value of the activity by the number of days and minutes.
The results are evaluated in three categories: inactive, moderately active, and active: Inactive, Moderately active, Active (Craig et al., 2003).
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Baseline and through study completion, an average of 6 weeks
|
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Quality of Life Assessment
Time Frame: Baseline and through study completion, an average of 6 weeks
|
Patients' quality of life will be assessed using the Short Form-36 (SF-36).
It consists of eight sub-items: physical function, social function, role limitations due to physical problems, pain, vitality, mental health, and general health perception.
Each sub-item is scored between 0 and 100, and these scores are not added together.
A high score indicates good health.
The Turkish validity and reliability study of the scale was conducted by Demiral et al. (Demiral et al., 2006).
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Baseline and through study completion, an average of 6 weeks
|
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Chest Expansion Measurement
Time Frame: Baseline and through study completion, an average of 6 weeks
|
Chest expansion was assessed by measuring the circumference of the chest wall at maximum inspiration and maximum expiration.
Measurements were taken with a measuring tape at the axillary (level of the 4th rib), epigastric (level of the xiphoid process), and subcostal (above the 11th and 12th ribs) levels while the person was in an upright sitting position.
Participants were asked to perform maximum inspiration and expiration, and the difference between the two was recorded in centimeters.
Each measurement was repeated three times for each of the three regions (Otman and Köse, 2014).
|
Baseline and through study completion, an average of 6 weeks
|
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Fatigue Assessment
Time Frame: Baseline and through study completion, an average of 6 weeks
|
Patients' fatigue was assessed using the Turkish adaptation of the Fatigue Severity Scale (Appendix-6).
The scale consists of 9 questions, and patients were asked to indicate their response using a number from 1 to 7, with 1 indicating complete disagreement and 7 indicating complete agreement.
The possible score range for the questionnaire is 9-63 (Gencay-Can and Can, 2012; Armutlu et al., 2007).
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Baseline and through study completion, an average of 6 weeks
|
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Harvard Step Test
Time Frame: Baseline and through study completion, an average of 6 weeks
|
This test, used to measure cardiopulmonary endurance and physical fitness, involves individuals climbing and descending steps for 5 minutes.
During ascent and descent, the feet must switch positions and remain side-by-side.
Heart rate and oxygen levels are measured before and after the test.
Heart rate is measured at 1, 2, and 3 minutes after the test ends.
The result is calculated as: (Test duration (seconds) x 100) / (Sum of 2 x recovery heart rates) (Mackenzie, 2005).
Results are scored as follows: 90 and above excellent, 80-89 good, 65-79 moderate, 55-64 poor, and 54 and below very poor (Babu et al., 2015).
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Baseline and through study completion, an average of 6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Büşra KAYABINAR, PhD, University of Yalova
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/552
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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