Low Back DisorderNCT07679425
Effect of Pneumatic Compression on Diaphragmatic Excursion in Hemodialysis Patients With Low Back Dysfunction
A study testing Pneumatic compression device and Inspiratory muscle Trainer in people with Low Back Disorder, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to investigate any significant effect of pneumatic compression on diaphragmatic excursion in patients with low back dysfunction . Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Low Back Disorder
- What is being tested?
- Pneumatic compression device and Inspiratory muscle Trainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients have been on regular hemodialysis (three sessions a week) at least 6 months before the start of the study
- Patients 'Age between 40 and 60 years old
- Patients have not participated in any physical activity program at least 6 months before the start of the study
- Patients have chronic back pain > 3months
- Patients has non specific low back pain
- Body mass index (BMI) from 25 to 34.9 kg/m2.
- Patients are clinically and medically stable
Who cannot join
- Instability of patient's medical condition
- Patients with chest infection
- Inability to comprehend and follow instructions as in dementia or speech problems such as dysphasia,
- uncontrolled diabetes mellitus,
- Persistent systolic Blood Pressure (BP) greater than 200 mmHg, persistent diastolic BP greater than 120 mmHg
- Chronic lung disease which result in significant oxygen desaturation on exercise or pulmonary congestion
- Patients with lupus nephritis.
- Patients with Spondylodiscitis , Compression fracture, Spinal stenosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study will be conducted to investigate any significant effect of pneumatic compression on diaphragmatic excursion in patients with low back dysfunction .
Read the detailed description
The prevalence of the musculoskeletal manifestations is high (76.4%) in the hemodialysis population .Pain is the most frequently reported symptom (44.9%). Seven studies (28%) reported back pain With a prevalence ranging from 14.29%-52%. In hemodialysis patients, Low back pain (LBP) can be attributed to sedentary lifestyle ،low physical performance, muscular weakness ،psychological factors, altered metabolic activity of the bones and joints, and rare causes such as tumor, spinal infection, and osteoporotic fractures.
Diaphragm is an important component of spine lumbar stability. In presence of low back pain ،there may be some alterations in this muscle like other muscles that are responsible for lumbar stabilization. Respiratory muscle training (RMT) has been proven to reduce pain intensity and improve respiratory muscle strength, physical function, balance, and consequently، the overall quality of life in several population groups.
Pneumatic compression device had a significant improvement in pulmonary functions and inspiratory muscle training. And pneumatic compression can be considered as an effective component for pulmonary rehabilitation in chronic obstructive pulmonary lung disease. patients. Up to investigated knowledge, No previous studies conducted to explore the effect of pneumatic compression versus Inspiratory muscle training on diaphragmatic function in patients with low back dysfunction .
- Conditions
- Low Back Disorder
- Being tested
- Pneumatic compression device, Inspiratory muscle Trainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumatic compression deviceDevice
Training program in the form of resisted inspiratory exercises using pneumatic compression device with abdominal sleeve on the top portion of the abdominal cavity beneath the xiphoid process. The patient used a pursed-lip breathing method to exhale after inhaling slowly through the nose such that the stomach slid out against the abdominal sleeve of the device. For 12 weeks, three times per week, the workout consisted of 10 sets with 4-5 breaths in each set and a rest period of 2-3 minutes.
Inspiratory muscle TrainerDevice
the subject underwent training in the form of six sets of five deep breaths against the trainer, with 1-2 minutes of rest in between sessions. Depending on their rate of perceived exertion, the patient determined the maximum training load at which they could effectively perform 10 breaths at maximum resistance. A load equivalent to 30% of the patient's maximum inspiratory effort was used to begin the training .This unique load gradually increased as the inspiratory muscle got stronger. At the conclusion of the three months, the training programmer had expanded by 5% to 10% per week, reaching 60% of the maximum inspiratory pressure.
| Study group | Role | What they receive |
|---|---|---|
| Pneumatic compression and inspiratory muscle Trainer group | Experimental | Participants will receive resisted inspiratory exercises using pneumatic compression abdominal belt in addition to inspiratory muscle Trainer (3 sessions per week) for 12 weeks Receives: Device: Pneumatic compression device; Device: Inspiratory muscle Trainer |
| Inspiratory muscle Trainer group | Active comparator | Participants will receive only training of the inspiratory muscles by (Threshold Inspiratory Muscle Trainer) (3 sessions per week) for 12 weeks Receives: Device: Inspiratory muscle Trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic excursion
Ultrasonography is an ideal tool and easy to be operated for evaluating diaphragm function. Low thickening ratio at forced respiration is an early indicator of diaphragm dysfunction and is associated with adverse clinical outcomes in hemodialysis (HD) patients. These findings suggest that routine screening for diaphragm dysfunction is in HD patients and intervention of diaphragm dysfunction is expected to be a novel strategy for improving the clinical outcomes in HD patients.
Measured: 12 weeks
Pain intensity
Visual analogue scale (VAS) will be used to assess pain intensity. it is 10 centimeter line with 2 ends; 0 indicates no pain and 10 indicates the worst pain.
Measured: 12 weeks
functional capacity
The 6 Minute Walk Test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The patient will rest comfortably for 10 minutes prior to the test. During this time blood pressure and heart rate are measured and potential contraindications assessed. The 6MWT will be performed on the walking track in which is 30 meters on one lap and two small cones will be used to mark the walking track boundaries.
Measured: 12 weeks
Secondary outcomes (2)
Functional disability
The Oswestry Disability Index (ODI) has become well-researched gold standard for assessing the severity of disability caused by back pain. The ODI covers 1 item on pain and 9 items on activities of daily living (personal care, lifting, walking، sitting, standing, sleeping, sex life, social life, and traveling. Each section contains 6 statements scored from 0 to 5, where 0 is no disability and 5 is the maximum. Scores are calculated as a percentage: (Total Points ÷ Total Possible Points) × 100.
Measured: 12 weeks
Health-related Quality of life
The SF-12 Health Survey Questionnaire is used to evaluate the health-related quality of life (HR-QoL) before and after the interventions. The SF-12 consists of 12 questions that examine eight different health domains in order to determine physical and mental health. General Health (GH), Physical Functioning (PF), Role Physical RP), and Body Pain (BP) are the physical health domains. Vitality) VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH) are mental health-related scales. A score above 50 indicates better-than-average health, while a score below 50 indicates below-average perceived health.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back DisorderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Atif Azab Othman, Cairo University
- Investigators
- Hany Saeed, As Professor, Study director, Cairo UniversityHeba Abd Elghafar, As professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679425
- Sponsor's protocol ID
- P.T.REC/012/005447
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pneumatic Compression on Diaphragmatic Excursion in Hemodialysis Patients With Low Back Dysfunction
- ClinicalTrials.gov ID
- NCT07679425
- Acronym / sponsor ID
- P.T.REC/012/005447
- Conditions
- Low Back Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 1 Jul 2026 (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.
This study will be conducted to investigate any significant effect of pneumatic compression on diaphragmatic excursion in patients with low back dysfunction .
Detailed description
The prevalence of the musculoskeletal manifestations is high (76.4%) in the hemodialysis population .Pain is the most frequently reported symptom (44.9%). Seven studies (28%) reported back pain With a prevalence ranging from 14.29%-52%. In hemodialysis patients, Low back pain (LBP) can be attributed to sedentary lifestyle ،low physical performance, muscular weakness ،psychological factors, altered metabolic activity of the bones and joints, and rare causes such as tumor, spinal infection, and osteoporotic fractures.
Diaphragm is an important component of spine lumbar stability. In presence of low back pain ،there may be some alterations in this muscle like other muscles that are responsible for lumbar stabilization. Respiratory muscle training (RMT) has been proven to reduce pain intensity and improve respiratory muscle strength, physical function, balance, and consequently، the overall quality of life in several population groups.
Pneumatic compression device had a significant improvement in pulmonary functions and inspiratory muscle training. And pneumatic compression can be considered as an effective component for pulmonary rehabilitation in chronic obstructive pulmonary lung disease. patients. Up to investigated knowledge, No previous studies conducted to explore the effect of pneumatic compression versus Inspiratory muscle training on diaphragmatic function in patients with low back dysfunction .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumatic compression and inspiratory muscle Trainer group | Experimental | Device: Pneumatic compression device, Device: Inspiratory muscle TrainerParticipants will receive resisted inspiratory exercises using pneumatic compression abdominal belt in addition to inspiratory muscle Trainer (3 sessions per week) for 12 weeks |
| Inspiratory muscle Trainer group | Active comparator | Device: Inspiratory muscle TrainerParticipants will receive only training of the inspiratory muscles by (Threshold Inspiratory Muscle Trainer) (3 sessions per week) for 12 weeks |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients have been on regular hemodialysis (three sessions a week) at least 6 months before the start of the study
- Patients 'Age between 40 and 60 years old
- Patients have not participated in any physical activity program at least 6 months before the start of the study
- Patients have chronic back pain > 3months
- Patients has non specific low back pain
Key exclusion criteria (8 listed)
- Instability of patient's medical condition
- Patients with chest infection
- Inability to comprehend and follow instructions as in dementia or speech problems such as dysphasia,
- uncontrolled diabetes mellitus,
- Persistent systolic Blood Pressure (BP) greater than 200 mmHg, persistent diastolic BP greater than 120 mmHg
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 |
|---|---|---|
| Pneumatic compression deviceTraining program in the form of resisted inspiratory exercises using pneumatic compression device with abdominal sleeve on the top portion of the abdominal cavity beneath the xiphoid process. The patient used a pursed-lip breathing method to exhale after inhaling slowly through the nose such that the stomach slid out against the abdominal sleeve of the device. For 12 weeks, three times per week, the workout consisted of 10 sets with 4-5 breaths in each set and a rest period of 2-3 minutes. | Device | Pneumatic compression and inspiratory muscle Trainer group |
| Inspiratory muscle Trainerthe subject underwent training in the form of six sets of five deep breaths against the trainer, with 1-2 minutes of rest in between sessions. Depending on their rate of perceived exertion, the patient determined the maximum training load at which they could effectively perform 10 breaths at maximum resistance. A load equivalent to 30% of the patient's maximum inspiratory effort was used to begin the training .This unique load gradually increased as the inspiratory muscle got stronger. At the conclusion of the three months, the training programmer had expanded by 5% to 10% per week, reaching 60% of the maximum inspiratory pressure. | Device | Inspiratory muscle Trainer group, Pneumatic compression and inspiratory muscle Trainer group |
Primary outcome
Diaphragmatic excursion
Time frame: 12 weeks
Ultrasonography is an ideal tool and easy to be operated for evaluating diaphragm function. Low thickening ratio at forced respiration is an early indicator of diaphragm dysfunction and is associated with adverse clinical outcomes in hemodialysis (HD) patients. These findings suggest that routine screening for diaphragm dysfunction is in HD patients and intervention of diaphragm dysfunction is expected to be a novel strategy for improving the clinical outcomes in HD patients.
Pain intensity
Time frame: 12 weeks
Visual analogue scale (VAS) will be used to assess pain intensity. it is 10 centimeter line with 2 ends; 0 indicates no pain and 10 indicates the worst pain.
functional capacity
Time frame: 12 weeks
The 6 Minute Walk Test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The patient will rest comfortably for 10 minutes prior to the test. During this time blood pressure and heart rate are measured and potential contraindications assessed. The 6MWT will be performed on the walking track in which is 30 meters on one lap and two small cones will be used to mark the walking track boundaries.
2 secondary outcomes
Functional disability
Time frame: 12 weeks
Health-related Quality of life
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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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.
Hany Saeed, As Professor study director
Cairo University
Heba Abd Elghafar, As professor study chair
Cairo 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 Pneumatic compression device and Inspiratory muscle Trainer in people with Low Back Disorder, run by Cairo University at 1 site in Egypt.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 1 Jul 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hagar Azab, Master (01018746727, hagaratif92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic excursion (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 1 Jul 2026.