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Clinical Trials/NCT07679425
NCT07679425Not yet recruitingNot Applicable

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

Cairo University1 site in 1 country50 target enrollmentStarted: July 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
50
Locations
1
Primary Endpoint
Diaphragmatic excursion

Study Overview

Brief Summary

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 60 Years (Adult)
Sex
All
Accepts 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/m
  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Functional disability(12 weeks)
  • Health-related Quality of life(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hagar Atif Azab Othman

Principal investigator

Cairo University

Study Sites (1)

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Effect of Pneumatic Compression on... | Clinical Trial