Effect of Pneumatic Compression on Diaphragmatic Excursion in Hemodialysis Patients With Low Back Dysfunction

This study will be conducted to investigate any significant effect of pneumatic compression on diaphragmatic excursion in patients with low back dysfunction .

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Disorder
• Intervention / Treatment: Device: Pneumatic compression device; Device: Inspiratory muscle Trainer

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hagar Azab, Master; Phone Number: 01018746727; Email: hagaratif92@gmail.com
• Study Contact Backup: Name: Shimaa Ali, As professor; Phone Number: 01144242511; Email: shymaaali@pt.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Hagar Atif Azab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pneumatic compression and inspiratory muscle Trainer group; Participants will receive resisted inspiratory exercises using pneumatic compression abdominal belt in addition to inspiratory muscle Trainer (3 sessions per week) for 12 weeks	Device: Pneumatic compression device; 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.; Device: Inspiratory muscle Trainer; 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.
Active Comparator: Inspiratory muscle Trainer group; Participants will receive only training of the inspiratory muscles by (Threshold Inspiratory Muscle Trainer) (3 sessions per week) for 12 weeks	Device: Inspiratory muscle Trainer; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	12 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Hany Saeed, As Professor, Cairo university; Study Chair: Heba Abd Elghafar, As professor, Cairo university

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Equipment and Supplies; Intermittent Pneumatic Compression Devices
• Other Study ID Numbers: P.T.REC/012/005447

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No