Ireland
--:--IST
Starting soon Not applicable

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

NCT07679425 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-07-01
Last updated
2026-07-01

Condition(s) studied

Low Back Disorder

Investigational drug(s) / intervention(s)

Pneumatic compression deviceInspiratory muscle Trainer

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.

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.

Study summary

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

Eligibility

Sex
ALL
Min age
40 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Diaphragmatic excursion — 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 — 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 — 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.

Trial sites (1)

FacilityCityRegionStatus
Hagar Atif Azab Cairo Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07679425 on ClinicalTrials.gov ↗ ← All trials in Egypt