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

NCT07679425 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005447
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Back Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Functional disability

  12 weeks

• Health-related Quality of life

  12 weeks

Study Arms (2)

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

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

Device: Inspiratory muscle Trainer

Interventions

Pneumatic compression device 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.

Pneumatic compression and inspiratory muscle Trainer group

Inspiratory muscle Trainer DEVICE

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.

Inspiratory muscle Trainer group; Pneumatic compression and inspiratory muscle Trainer group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hagar Atif Azab

Cairo, Egypt

Location

MeSH Terms

Interventions

Intermittent Pneumatic Compression Devices

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Hany Saeed, As Professor

  Cairo University

  STUDY DIRECTOR

• Heba Abd Elghafar, As professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Hagar Azab, Master

CONTACT

01018746727; hagaratif92@gmail.com

Shimaa Ali, As professor

CONTACT

01144242511; shymaaali@pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

EG (1)