Low Back PainNCT06958744
Effects of Functional Inspiratory Muscle Training in Patients With Chronic Non-Specific Low Back Pain
A study testing Functional Inspiratory Muscle Training (FIMT) group in people with Low Back Pain, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to investigate the effects of functional respiratory muscle training on diaphragm function, core stabilization, respiratory muscle strength, pain and functional status in patients with chronic non-specific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Functional Inspiratory Muscle Training (FIMT) group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2025to 17 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Low back pain lasting at least 3 months
- Being between the ages of 18 and 55
- Scoring 4 or more on the Numeric Pain Scale for the severity of low back pain
- Having a non-specific origin (not caused by a specific pathology such as -Infection, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome)
- Individuals with inspiratory muscle strength ≥80 mmHg
- Individuals with a forced expiratory volume (FEV1) of 80% or more
Who cannot join
- Tumor history
- Spine surgery in the last 12 months
- Spinal pathology (spondylolysis or spondylolisthesis) or concomitant neurological disease or neurological findings in the leg
- Having a chronic systemic disease
- Pregnancy
- Having a disease that affects the lungs and causes breathing problems
- Participation in a physiotherapy program in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculity of Health Sciences, Uskudar University
Istanbul, Ümraniye, 34764
About this study
Official title: Effects of Functional Inspiratory Muscle Training on Diaphragm Function and Core Stabilization in Patients With Chronic Non-Specific Low Back Pain
The aim of the study was to investigate the effects of functional respiratory muscle training on diaphragm function, core stabilization, respiratory muscle strength, pain and functional status in patients with chronic non-specific low back pain.
Read the detailed description
Patients with chronic non-specific low back pain (CNSBP) have imbalances in postural control and kinetic chain. Postural control and respiratory function are mechanically and neuromuscularly interdependent. The diaphragm is the primary muscle in active inspiration with a vital role in contributing to spinal stability by modulating intra-abdominal pressure. The attachment of the diaphragm to the lumbar spine creates a synergistic working pattern with the transversus abdominis muscle. Altered activation patterns of the diaphragm and transversus abdominis have been observed in patients with chronic low back pain. Therefore, diaphragm function and respiratory pattern play a critical role in achieving and maintaining core stabilization. Studies have supported that different respiratory exercise programs are effective in reducing pain intensity, improving respiratory function and quality of life in CNSBP. These studies suggest a possible link between respiratory function, respiratory pattern, core stability and low back pain.
Inspiratory muscle training (IMT) is a technique used to increase the strength or endurance of the diaphragm and auxiliary respiratory muscles with a pressure threshold device. IMT consists of exercises involving breathing against resistance to improve respiratory muscle strength and aerobic capacity in healthy and sick populations. Respiratory muscles are also trunk muscles and their performance cannot be sufficiently optimized when respiratory muscle training is performed in isolation. Furthermore, if the load on the diaphragm, which has inspiratory, postural control and trunk stabilization tasks, increases, the muscle prefers breathing over these tasks. Functional training of the respiratory muscles is therefore recommended for optimal performance of the respiratory muscles. Functional inspiratory muscle training (FIMT) is defined as inspiratory respiratory muscle training during exercises in specific body positions. FIMT stimulates both the respiratory system and the core stabilization muscles as it consists of trunk and lumbopelvic exercises with stabilization of the spinal region during inspiratory load. Compared to traditional inspiratory muscle training, FIMT has a greater effect because it improves two roles of respiratory muscles (ventilation and spinal stabilization).
This study will investigate the effects of functional inspiratory muscle training (FIMT) on diaphragm thickness and mobility, respiratory muscle strength, core stabilization, pain and functional status in patients with CNSLBP.
- Conditions
- Low Back Pain
- Being tested
- Functional Inspiratory Muscle Training (FIMT) group, Control group
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Inspiratory Muscle Training (FIMT) groupOther
Training will be given with the Powerbreath inspiratory muscle training device. Unlike traditional inspiratory muscle training, the exercises given in FIMT aim to integrate the functional capacity of respiratory muscles into daily life activities and include dynamic exercises in different positions with variable resistances. In this respect, it is defined as functional. Preparatory training will be given 4 weeks before starting FIMT: participants will be taught basic respiratory muscle training, respiratory control and exercises, and will be taught to perform the exercises while maintaining the spine in a neutral position. Patients will then be taken to FIMT for 3 days/6 weeks with a physiotherapist. On the other 3 days of the week, only inspiratory muscle training will be performed. The intensity of inspiratory muscle training will be increased from mild to moderate (Mild: Effort level between 20-40% of MIP or between Borg 2-3, Moderate: 50-60% of MIP or Borg 4-6).
Control groupOther
Thoracic expansion exercise will be performed for 10 weeks. The participant will be asked to practice 4 times a day as a home program.
| Study group | Role | What they receive |
|---|---|---|
| Functional Inspiratory Muscle Training (FIMT) group | Experimental | Training will be given with the Powerbreath inspiratory muscle training device. Unlike traditional inspiratory muscle training, the exercises given in FIMT aim to integrate the functional capacity of respiratory muscles into daily life activities and include dynamic exercises in different positions with variable resistances. In this respect, it is defined as functional. Preparatory training will be given 4 weeks before starting FIMT: participants will be taught basic respiratory muscle training, respiratory control and exercises, and will be taught to perform the exercises while maintaining the spine in a neutral position. Patients will then be taken to FIMT for 3 days/6 weeks with a physiotherapist. On the other 3 days of the week, only inspiratory muscle training will be performed. The intensity of inspiratory muscle training will be increased from mild to moderate (Mild: Effort level between 20-40% of MIP or between Borg 2-3, Moderate: 50-60% of MIP or Borg 4-6). Receives: Other: Functional Inspiratory Muscle Training (FIMT) group |
| Control group | Active comparator | Thoracic expansion exercise will be performed for 10 weeks. The participant will be asked to practice 4 times a day as a home program. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm Thickness
Diaphragm thickness (millimeter-mm) will be measured in the supine position with ultrasonography.
Measured: 10 weeks
Secondary outcomes (5)
The Numeric Rating Scale
NRS is a pain screening tool, used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
Measured: 10 weeks
Respiratory muscle strength
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements will be used to assess respiratory muscle strength.
Measured: 10 weeks
McGill Core Endurance Test
Trunk muscle endurance tests developed by McGill include Sorensen test, trunk flexion, trunk extension, right-left lateral bridge test.
Measured: 10 weeks
The Oswestry Disability Index
The Oswestry Disability Index (ODI) a patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. The questionnaire examines the level of disability in 10 everyday activities of daily living. Each item consist of 6 statements which are scored from 0 to 5. With 0 indicating the least disability and 5 the greatest then the total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability.
Measured: 10 weeks
Diaphragm Mobility
Diaphragm Mobility (millimeter-mm) will be measured in the supine position with ultrasonography.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start30 Apr 2025
- Primary completion17 Sep 2025
- Study completion17 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HATİCE HÜMEYRA AKIL, Uskudar University
- Investigators
- Filiz Eyüboğlu, Principal investigator, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958744
- Sponsor's protocol ID
- UUFTR01
- Status last verified
- Dec 2025
- First submitted
- 19 Apr 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional Inspiratory Muscle Training on Diaphragm Function and Core Stabilization in Patients With Chronic Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06958744
- Acronym / sponsor ID
- UUFTR01
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 17 Sep 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study was to investigate the effects of functional respiratory muscle training on diaphragm function, core stabilization, respiratory muscle strength, pain and functional status in patients with chronic non-specific low back pain.
Detailed description
Patients with chronic non-specific low back pain (CNSBP) have imbalances in postural control and kinetic chain. Postural control and respiratory function are mechanically and neuromuscularly interdependent. The diaphragm is the primary muscle in active inspiration with a vital role in contributing to spinal stability by modulating intra-abdominal pressure. The attachment of the diaphragm to the lumbar spine creates a synergistic working pattern with the transversus abdominis muscle. Altered activation patterns of the diaphragm and transversus abdominis have been observed in patients with chronic low back pain. Therefore, diaphragm function and respiratory pattern play a critical role in achieving and maintaining core stabilization. Studies have supported that different respiratory exercise programs are effective in reducing pain intensity, improving respiratory function and quality of life in CNSBP. These studies suggest a possible link between respiratory function, respiratory pattern, core stability and low back pain.
Inspiratory muscle training (IMT) is a technique used to increase the strength or endurance of the diaphragm and auxiliary respiratory muscles with a pressure threshold device. IMT consists of exercises involving breathing against resistance to improve respiratory muscle strength and aerobic capacity in healthy and sick populations. Respiratory muscles are also trunk muscles and their performance cannot be sufficiently optimized when respiratory muscle training is performed in isolation. Furthermore, if the load on the diaphragm, which has inspiratory, postural control and trunk stabilization tasks, increases, the muscle prefers breathing over these tasks. Functional training of the respiratory muscles is therefore recommended for optimal performance of the respiratory muscles. Functional inspiratory muscle training (FIMT) is defined as inspiratory respiratory muscle training during exercises in specific body positions. FIMT stimulates both the respiratory system and the core stabilization muscles as it consists of trunk and lumbopelvic exercises with stabilization of the spinal region during inspiratory load. Compared to traditional inspiratory muscle training, FIMT has a greater effect because it improves two roles of respiratory muscles (ventilation and spinal stabilization).
This study will investigate the effects of functional inspiratory muscle training (FIMT) on diaphragm thickness and mobility, respiratory muscle strength, core stabilization, pain and functional status in patients with CNSLBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Inspiratory Muscle Training (FIMT) group | Experimental | Other: Functional Inspiratory Muscle Training (FIMT) groupTraining will be given with the Powerbreath inspiratory muscle training device. Unlike traditional inspiratory muscle training, the exercises given in FIMT aim to integrate the functional capacity of respiratory muscles into daily life activities and include dynamic exercises in different positions with variable resistances. In this respect, it is defined as functional. Preparatory training will be given 4 weeks before starting FIMT: participants will be taught basic respiratory muscle training, respiratory control and exercises, and will be taught to perform the exercises while maintaining the spine in a neutral position. Patients will then be taken to FIMT for 3 days/6 weeks with a physiotherapist. On the other 3 days of the week, only inspiratory muscle training will be performed. The intensity of inspiratory muscle training will be increased from mild to moderate (Mild: Effort level between 20-40% of MIP or between Borg 2-3, Moderate: 50-60% of MIP or Borg 4-6). |
| Control group | Active comparator | Other: Control groupThoracic expansion exercise will be performed for 10 weeks. The participant will be asked to practice 4 times a day as a home program. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Low back pain lasting at least 3 months
- Being between the ages of 18 and 55
- Scoring 4 or more on the Numeric Pain Scale for the severity of low back pain
- Having a non-specific origin (not caused by a specific pathology such as -Infection, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome)
- Individuals with inspiratory muscle strength ≥80 mmHg
Key exclusion criteria (7 listed)
- Tumor history
- Spine surgery in the last 12 months
- Spinal pathology (spondylolysis or spondylolisthesis) or concomitant neurological disease or neurological findings in the leg
- Having a chronic systemic disease
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Inspiratory Muscle Training (FIMT) groupTraining will be given with the Powerbreath inspiratory muscle training device. Unlike traditional inspiratory muscle training, the exercises given in FIMT aim to integrate the functional capacity of respiratory muscles into daily life activities and include dynamic exercises in different positions with variable resistances. In this respect, it is defined as functional. Preparatory training will be given 4 weeks before starting FIMT: participants will be taught basic respiratory muscle training, respiratory control and exercises, and will be taught to perform the exercises while maintaining the spine in a neutral position. Patients will then be taken to FIMT for 3 days/6 weeks with a physiotherapist. On the other 3 days of the week, only inspiratory muscle training will be performed. The intensity of inspiratory muscle training will be increased from mild to moderate (Mild: Effort level between 20-40% of MIP or between Borg 2-3, Moderate: 50-60% of MIP or Borg 4-6). | Other | Functional Inspiratory Muscle Training (FIMT) group |
| Control groupThoracic expansion exercise will be performed for 10 weeks. The participant will be asked to practice 4 times a day as a home program. | Other | Control group |
Primary outcome
Diaphragm Thickness
Time frame: 10 weeks
Diaphragm thickness (millimeter-mm) will be measured in the supine position with ultrasonography.
5 secondary outcomes
The Numeric Rating Scale
Time frame: 10 weeks
Respiratory muscle strength
Time frame: 10 weeks
McGill Core Endurance Test
Time frame: 10 weeks
The Oswestry Disability Index
Time frame: 10 weeks
Diaphragm Mobility
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filiz Eyüboğlu principal investigator
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Inspiratory Muscle Training (FIMT) group in people with Low Back Pain, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm Thickness (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.