Respiratory Muscle Training and Quality of Life in Hemodialysis Patients

NCT ID: NCT07183696

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-10-31

Brief Summary

This study investigates the effect of breath booster training on respiratory muscle strength and quality of life in patients undergoing hemodialysis. It aims to determine whether targeted respiratory training can improve pulmonary function, enhance physical performance, and positively impact overall well-being in this population.

Detailed Description

Detailed Description Statement of the problem Does Breath Booster training have an effect on respiratory muscle strength and quality of life in hemodialysis patients? Purpose of the study

The study aims to:

Investigate the effect of the Breath Booster device on respiratory muscle strength in patients undergoing dialysis.

Evaluate the impact of the Breath Booster device on the quality of life of patients undergoing dialysis.

Assess the effect of the Breath Booster device on exercise capacity in dialysis patients.

Significance of the study The burden of chronic kidney disease (CKD) in Egypt has increased significantly over the past decade, with a 36% rise in cases between 2009 and 2019. CKD is now the fifth leading cause of death in the country, highlighting the urgent need for effective patient-centered interventions. A 2024 report underscored the importance of implementing a comprehensive renal registry to improve patient outcomes and lessen the healthcare burden.

Hemodialysis patients face substantial challenges, including adherence to strict dietary and fluid restrictions, repeated dialysis sessions each week, and vascular access care. These lifestyle demands often contribute to reduced physical function, lower quality of life, and increased psychological stress.

Moreover, respiratory muscle weakness is a common complication among CKD patients, particularly those on hemodialysis. This impairment reduces functional capacity and negatively impacts quality of life. Inspiratory muscle training (IMT) has recently emerged as a promising, non-pharmacological method to address this issue.

Given these factors, the present study seeks to evaluate the effectiveness of the Breath Booster device in improving respiratory muscle strength, quality of life, and exercise capacity in hemodialysis patients.

Delimitation

This study will be delimited to:

Forty patients participating in the study. Age range between 50-60 years. Patients diagnosed with end-stage renal disease (CKD stage 5) on hemodialysis. Patients who have been undergoing regular hemodialysis for 1-3 years.

Null Hypothesis There will be no significant effect of Breath Booster training on respiratory muscle strength and quality of life in hemodialysis patients.

Conditions

Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Placebo

will receive respiratory physical therapy sessions in the form of breathing exercises, chest percussion, and vibration 3 times per week during dialysis sessions for 6 weeks

Group Type: PLACEBO_COMPARATOR

breathing exercises

Intervention Type: OTHER

• breathing exercises as needed 3 times per week during dialysis sessions.
• chest percussion as needed 3 times per week during dialysis sessions.
• vibration as needed 3 times per week during dialysis sessions.

Intervention Group

will receive respiratory physicaltherapy sessions in the form of breathing exercises, chest percussion, and vibration 3 times per week during dialysis sessions for 6 weeks and training on the breath booster device at the same session

Group Type: EXPERIMENTAL

breathing exercises

Intervention Type: OTHER

• breathing exercises as needed 3 times per week during dialysis sessions.
• chest percussion as needed 3 times per week during dialysis sessions.
• vibration as needed 3 times per week during dialysis sessions.

Interventions

breathing exercises

• breathing exercises as needed 3 times per week during dialysis sessions.
• chest percussion as needed 3 times per week during dialysis sessions.
• vibration as needed 3 times per week during dialysis sessions.

Intervention Type: OTHER

Other Intervention Names

chest percussion; vibration

Eligibility Criteria

Inclusion Criteria

1. Fifty patients will be included in this study.

2. Their ages will range from 50 to 60 years.

3. Patients with end-stage renal disease (grade 5) receiving hemodialysis.

4. Patients on hemodialysis for around 1 to 3 years.

5. They will be able to follow instructions during evaluation and treatment.

Exclusion Criteria

1. Diabetes Mellitus,

2. Morbid obesity with a BMI of more than 35 kg/m2.

3. Hearing or visual impairments.

4. Any severe chest diseases like COPD.

5. Certain contraindications for the use of the Breath Booster. Individuals with severe respiratory conditions such as unstable asthma, or emphysema, or those who have recently undergone lung surgery

6. Uncontrolled seizures.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sameh Eldaly

director of scientific research committee

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of physical therapy cairo university

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Sameh Eldaly Sameh Eldaly

Role: CONTACT

info@sameheldaly.online

+201554076441

Facility Contacts

Amal yousef, Phd

Role: primary

dean@pt.cu.edu.eg

37617691

Other Identifiers

P.T.REC/012/005826

Identifier Type: -

Identifier Source: org_study_id