Active Cycle of Breathing TechniqueNCT07797530
The Effectiveness of Breathing Training in Subacute Neck Pain
A study testing Active Cycle of Breathing Technique, Active Comparator: Progressive Muscle Relaxation and Exercise Program in people with Active Cycle of Breathing Technique and Progressive Muscle Relaxation, run by Istanbul Topkapi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study is to investigate the effectiveness of breathing training added to a standard physical therapy and exercise program in individuals with non-specific subacute neck pain. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Active Cycle of Breathing Technique, Progressive Muscle Relaxation, Breathing Technique
- What is being tested?
- Active Cycle of Breathing Technique, Active Comparator: Progressive Muscle Relaxation and Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 30 Sep 2027
- Phase
- Interventional
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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 35-60 years, of either sex.
- Ability to read, write, and understand Turkish.
- Diagnosis of non-specific neck pain by a specialist physician.
- Neck pain duration of ≥6 weeks and <12 weeks, with pain intensity of ≥3/10 on the Visual Analog Scale (VAS).
Who cannot join
- Neck pain with an identified specific underlying cause, such as traumatic injury (e.g., fracture or dislocation), infection, tumor, significant nerve root or spinal cord compression, or systemic rheumatic/inflammatory disease.
- Upper cervical symptoms, including dizziness or lightheadedness.
- Diagnosed primary headache disorders, including migraine and tension-type headache.
- Persistent night pain, severe muscle spasm, unexplained weight loss, daily headache, loss of consciousness, or confusion.
- Cardiopulmonary or respiratory diseases.
- Acute or chronic musculoskeletal pain in other body regions that may interfere with participation in the exercise program.
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- Major surgery within the previous 6 months.
- Spinal, thoracic, or abdominal surgery within the previous 3 years.
- Current smoking or alcohol use.
- Physiotherapy or osteopathic treatment for the neck region within the previous 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Altıntepe Kızılay Medical Center
Istanbul, 34840
Duygu Bilginer, Physician., +90216 489 55 06, duygubilginer@gmail.com
About this study
The aim of this clinical study is to investigate the effectiveness of breathing training added to a standard physical therapy and exercise program in individuals with non-specific subacute neck pain. Specifically, the study will evaluate the effect of breathing training on functional loss due to neck pain and on respiratory function. The main questions it aims to answer are:
- Does breathing training reduce functional loss due to neck pain in participants?
- Does breathing training improve respiratory function in participants?
Read the detailed description
Researchers will compare Active Cycle of Breathing Technique (ACBT) with Progressive Muscle Relaxation(PMR).
Participants will be randomly divided to two groups: a study group and a control group.
Both groups will receive traditional physical therapy five days a week for three weeks.
The study group will receive Active Cycle of Breathing Technique and exercise three days a week for six weeks, while the Control Group will receive Progressive Muscle Relaxation and exercise three days a week for six weeks.
Participants will:
- Attend a total of 18 treatment sessions with a physiotherapist, 3 days a week for 6 weeks.
- Perform home exercises twice daily.
- Assessments will be conducted at the beginning of the study and after treatment at week 6.
The study will also evaluate changes in pain, posture, head position, muscle strength, joint position sense, anxiety and depression, severity of insomnia, and quality of life.
- Conditions
- Active Cycle of Breathing Technique, Progressive Muscle Relaxation, Breathing Technique, Neck Pain, Non Specific Neck Pain, Subacute Cervical Pain
- Being tested
- Active Cycle of Breathing Technique, Active Comparator: Progressive Muscle Relaxation, Exercise Program, Traditional Physiotherapy
- Keywords
- Active Cycle of Breathing Technique, Progressive Muscle Relaxation, Neck Pain, Breathing Technique, non specific neck pain, subacute cervical pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Cycle of Breathing TechniqueOther
The patient will sit comfortably in a chair in a quiet environment, with shoulders relaxed, and will be instructed to perform deep, slow breathing with prolonged exhalation. The cycle will be: Breathing Control-Thoracic Expansion Exercise (TEE)-Breathing Control-Thoracic Expansion Exercise-Breathing Control-Bilateral Thoracic Expansion Exercise (BTEE)-Breathing Control. Each step will be repeated 3-5 times. During TEE and BTEE, proprioceptive tactile stimulation will be applied by resistance during inhalation. The application procedure will be taught in sessions 1 and 2. At home, the patient will place their own hand where the therapist normally places theirs. The program will be performed 3 days/week for 6 weeks, 15-20 minutes/session. Participants will also be instructed to perform the technique at home twice daily.
Active Comparator: Progressive Muscle RelaxationOther
The patient will wear comfortable clothing and sit in a quiet environment. During Progressive Muscle Relaxation, the eyes will be closed and attention will be focused on the body, particularly on muscle tension and relaxation. The session will begin with deep breathing and relaxing music. During inhalation, each muscle group will be contracted for 5 seconds and relaxed for 10 seconds during exhalation, while other muscles remain relaxed. The technique will be applied in order to the hands, arms, face, neck, shoulders, chest, abdomen, back, hips, thighs, lower legs, and feet. At the end, all muscles will be contracted and relaxed together, and the relaxed position will be maintained for 2 minutes. The program will be performed 3 days/week for 6 weeks, 15-20 minutes/session.Participants will also be instructed to perform the technique at home twice daily.
Exercise ProgramOther
The exercise program will include active range of motion (AROM), stretching, scapular stabilization, deep cervical muscle, and postural exercises.
During weeks 1-2, the exercises will be performed as 1 set, progressing to 2 sets in week 3.
From week 4, resistance will be added to selected exercises as appropriate. These exercises will be performed as 1 set during weeks 4-5 and 2 sets during week 6.
The program will be performed under the supervision of a physiotherapist 3 days per week for 6 weeks, for a total of 18 sessions, with each session lasting 15-20 minutes. Participants will also be instructed to perform the exercises at home twice daily.
Traditional PhysiotherapyOther
Traditional physiotherapy will consist of electrotherapy modalities, including hot pack, ultrasound, interferential current, and transcutaneous electrical nerve stimulation (TENS). Traditional physiotherapy will be provided 5 days per week for 3 weeks, with each treatment session lasting 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Active Cycle of Breathing Technique Group | Experimental | Participants in this group will receive the Active Cycle of Breathing Technique and an exercise program 3 days per week for 6 weeks. In addition, traditional physiotherapy will be provided 5 days per week for 3 weeks. Receives: Other: Active Cycle of Breathing Technique; Other: Exercise Program; Other: Traditional Physiotherapy |
| Progressive Muscle Relaxation Group | Active comparator | Participants in this group will receive Progressive Muscle Relaxation and an exercise program 3 days per week for 6 weeks. In addition, traditional physiotherapy will be provided 5 days per week for 3 weeks. Receives: Other: Active Comparator: Progressive Muscle Relaxation; Other: Exercise Program; Other: Traditional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability
Neck disability will be assessed using the Neck Disability Index (NDI). The total score ranges from 0 to 50, with higher scores indicating greater disability.
Measured: Change from baseline neck disability at week 6.
Forced Expiratory Volume in 1 Second (FEV1)
Forced expiratory volume in 1 second (FEV1) will be assessed using a COSMED Pony FX spirometer according to ATS/ERS guidelines. FEV1 will be recorded in liters.
Measured: Change From Baseline in FEV1 at Week 6
Forced Vital Capacity (FVC)
Forced vital capacity (FVC) will be assessed using a COSMED Pony FX spirometer according to ATS/ERS guidelines. FVC will be recorded in liters.
Measured: Change from baseline in FVC at week 6
FEV1/FVC Ratio
The FEV1/FVC ratio will be calculated from spirometric measurements obtained using a COSMED Pony FX spirometer according to ATS/ERS guidelines. The FEV1/FVC ratio will be expressed as a percentage.
Measured: Change from baseline in FEV1/FVC ratio at week 6
Peak Expiratory Flow Rate (PEFR)
Peak expiratory flow rate (PEFR) will be assessed using a COSMED Pony FX spirometer according to ATS/ERS guidelines. PEFR will be recorded in liters per minute.
Measured: Change from baseline in PEFR at week 6
Slow Vital Capacity (SVC)
Slow vital capacity (SVC) will be assessed using a COSMED Pony FX spirometer according to ATS/ERS guidelines. SVC will be recorded in liters.
Measured: Change from baseline in SVC at week 6
Respiratory Muscle Strength
Respiratory muscle strength will be assessed using maximal inspiratory pressure (MIP, cmH₂O) and maximal expiratory pressure (MEP, cmH₂O). MIP will be used to assess inspiratory muscle strength, whereas MEP will be used to assess expiratory muscle strength.
Measured: Change from baseline respiratory muscle strength at week 6.
Pain Intensity
Pain intensity will be assessed using the Visual Analog Scale (VAS). The VAS consists of a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will mark the point that represents their pain intensity, and the score will be recorded in centimeters.
Measured: Change from baseline pain intensity at week 6.
Muscle Strength
Muscle strength will be assessed using Manual Muscle Testing (MMT) according to the Medical Research Council (MRC) scale. Muscle strength is scored from 0 to 5, with higher scores indicating greater muscle strength.
Measured: Change from baseline muscle strength at week 6.
Cervical Range of Motion
Cervical range of motion will be assessed using a Bubble Inclinometer. Cervical flexion, extension, right and left rotation, and right and left lateral flexion will be measured in degrees.
Measured: Change from baseline cervical range of motion at week 6.
Cervical Proprioception
Cervical proprioception will be assessed using the Laser Pointer-Assisted Angle Reproduction Test. Joint position error will be recorded in degrees.
Measured: Change from baseline cervical proprioception at week 6.
Cervical Muscle Endurance
Cervical flexor and extensor muscle endurance will be assessed using neck flexor and extensor endurance tests. The time that participants can maintain the required test position will be measured with a stopwatch and recorded in seconds.
Measured: Change from baseline cervical muscle endurance at week 6.
Posture
Posture will be assessed using the New York Posture Rating Test, which evaluates postural changes in 13 body regions. The total score ranges from 13 to 65, with higher scores indicating better posture.
Measured: Change from baseline posture at week 6.
Forward Head Posture
Forward head posture will be assessed by measuring the craniovertebral angle (CVA), defined as the angle between a horizontal line and the line connecting the midpoint of the tragus of the ear to the C7 spinous process. The angle will be recorded in degrees.
Measured: Change from baseline forward head posture at week 6.
Chest Mobility
Chest mobility will be assessed using the Chest Expansion Test. Chest expansion will be determined as the difference between chest circumference at maximal inspiration and maximal expiration and recorded in centimeters.
Measured: Change from baseline chest mobility at week 6.
Anxiety and Depression
Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). The scale consists of 14 items, with 7 items assessing anxiety and 7 assessing depression. Each subscale ranges from 0 to 21, with higher scores indicating greater symptom severity.
Measured: Change from baseline anxiety and depression at week 6.
Quality of Life Assessed by the SF-12
Quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12). Higher scores indicate better quality of life.
Measured: Change from baseline quality of life at week 6.
Insomnia Severity
Insomnia severity will be assessed using the Insomnia Severity Index (ISI). The ISI consists of 7 items, each scored from 0 to 4. The total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
Measured: Change from baseline insomnia severity at week 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion20 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Cycle of Breathing TechniqueStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Topkapi University
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University
- Responsible party
- Principal investigator, ibrahim aras, Istanbul Topkapi University
- Investigators
- İbrahim ARAS, Principal investigator, Istanbul Topkapı University, Istanbul,Türkiye,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797530
- Sponsor's protocol ID
- Istanbul Topkapi University
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No