NCT07488741

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Mar 2026Dec 2026

Study Start

First participant enrolled

March 9, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 17, 2026

Last Update Submit

March 22, 2026

Conditions

Keywords

SmokersExerciseProprioceptive Neuromuscular Facilitation (PNF) Stretching

Outcome Measures

Primary Outcomes (16)

  • Dyspnea Assessment

    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

    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

    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

    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

    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

    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

  • Pulmonary Function Testing

    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

  • Respiratory Muscle Strength Measurement

    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)

    Baseline and through study completion, an average of 6 weeks

  • Respiratory Muscle Strength Measurement

    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

    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)

    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).

    Baseline and through study completion, an average of 6 weeks

  • Physical Activity Level Assessment

    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).

    Baseline and through study completion, an average of 6 weeks

  • Quality of Life Assessment

    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).

    Baseline and through study completion, an average of 6 weeks

  • Chest Expansion Measurement

    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

  • Fatigue Assessment

    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).

    Baseline and through study completion, an average of 6 weeks

  • Harvard Step Test

    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).

    Baseline and through study completion, an average of 6 weeks

Study Arms (3)

Chest PNF Techniques Group

EXPERIMENTAL

Chest PNF exercises will be performed in supine, side, and prone positions. Each technique will be performed 12 times.

Other: Chest PNF Techniques Group

Chest Mobility Exercises Group

EXPERIMENTAL

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.

Other: Chest Mobility Exercises Group

Control

NO INTERVENTION

No action will be taken.

Interventions

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

Chest PNF Techniques Group

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.

Chest Mobility Exercises Group

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yalova University

Yalova, Yalova, Turkey (Türkiye)

RECRUITING

Related Publications (43)

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MeSH Terms

Conditions

SmokingMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Büşra KAYABINAR, PhD

    University of Yalova

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: a single blind randomised
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 23, 2026

Study Start

March 9, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations