An interventional study of Functional Inspiratory Muscle Training (FIMT) group and Control group in Low Back Pain, sponsored by Uskudar University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Uskudar University · Not applicable, Interventional, and Treatment
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.
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.
2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 2,268 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Uskudar University is the lead sponsor of 164 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
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).
Other: Functional Inspiratory Muscle Training (FIMT) group
Thoracic 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
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).
Thoracic expansion exercise will be performed for 10 weeks. The participant will be asked to practice 4 times a day as a home program.
Diaphragm Thickness
Diaphragm thickness (millimeter-mm) will be measured in the supine position with ultrasonography.
Time frame: 10 weeks
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".
Time frame: 10 weeks
Respiratory muscle strength
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements will be used to assess respiratory muscle strength.
Time frame: 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.
Time frame: 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.
Time frame: 10 weeks
Diaphragm Mobility
Diaphragm Mobility (millimeter-mm) will be measured in the supine position with ultrasonography.
Time frame: 10 weeks
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Uskudar University