Respiratory Muscle Training and Quality of Life in Hemodialysis Patients

Cairo University (CU)

Status: Enrolling

Conditions: Hemodialysis

Treatments: Other: breathing exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT07183696

P.T.REC/012/005826

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 50 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: breathing exercises

Intervention Group

Experimental group

Description:

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

Treatment:

Other: breathing exercises