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临床试验/NCT07488741
NCT07488741招募中不适用

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

University of Yalova1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年3月9日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Dyspnea Assessment

研究概览

简要总结

Smoking is a significant risk factor for heart, lung, and respiratory system diseases, and is particularly prevalent among young people and university students. In Turkey, tobacco use is high in the 15-24 age group, and smoking rates among university students are reported to be between 20% and 43%. Besides causing COPD and other respiratory diseases, smoking negatively impacts performance by increasing fatigue, dyspnea, and pain during exercise. It impairs lung function, reducing respiratory volumes such as FVC and FEV1. PNF and chest mobility exercises targeting the chest area can improve respiratory parameters by increasing respiratory muscle function and thoracic mobility. Recent studies show that chest PNF techniques have positive effects on lung function, chest expansion, and some physiological parameters, especially in smokers.

详细描述

Smoking, due to the various chemical substances it contains, constitutes a risk factor for many diseases, primarily heart and lung diseases (Durhan, 2024). It has been reported that smoking rates are higher among students living in underdeveloped or developing countries (Karlıkaya et al., 2006). 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% (Bostan et al., 2024). Due to harmful substances like nicotine, smoking can lead to COPD, atherosclerosis, and other respiratory diseases (Seo et al., 2015). Furthermore, individuals who smoke are more likely to stop exercising due to fatigue, dyspnea, and pain (Akgül et al., 2024). Smoking negatively impacts lung capacity, reducing FVC, FEV1, and FEV1/FVC volumes while increasing RV volume (Singh et al., 2011; Mumtaz et al., 2020). Proprioceptive neuromuscular facilitation (PNF) techniques targeting the chest area are used in various populations to enhance respiratory muscle function and improve respiratory parameters (Zwoliński et al., 2022; Jyothi et al., 2022; Dsilva and Kanase, 2024). 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 (Leelarungrayub, 2012). 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 (Bhatnagar, 2022; Ahirwar and Tiwari, 2024). A study conducted on female smokers showed that chest PNF technique followed by breathing exercises regulated blood pressure (Kumar et al., 2024).

Objective: The aim of our 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Cardiac event or lung surgery in the last 6 months Respiratory problems such as COPD, asthma Orthopedic and neurological problems Termination of volunteering

结局指标

主要结局

Dyspnea Assessment

时间窗: 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).

Pulmonary Function Testing

时间窗: 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).

Respiratory Muscle Strength Measurement

时间窗: 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)

Exercise Capacity Assessment

时间窗: 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.

Depression Assessment (Beck Depression Inventory-BDI)

时间窗: 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).

Physical Activity Level Assessment

时间窗: 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).

Quality of Life Assessment

时间窗: 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).

Chest Expansion Measurement

时间窗: 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).

Fatigue Assessment

时间窗: 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).

Harvard Step Test

时间窗: 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).

次要结局

未报告次要终点

研究者

发起方
University of Yalova
申办方类型
Other
责任方
Principal Investigator
主要研究者

BÜŞRA KAYABINAR

Assistant Professor

University of Yalova

研究点 (1)

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