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Respiratory Muscle Training and Quality of Life in Hemodialysis Patients

Effect of Breath Booster Training on Respiratory Muscle Strength and Quality of Life in Hemodialysis Patients

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07183696
Enrollment
50
Registered
2025-09-19
Start date
2024-10-01
Completion date
2025-10-31
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis

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.

Interventions

OTHERbreathing 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Respiratory Muscle Strength measured using Respiratory Pressure Manometers6 weeksOutcomes include maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), recorded in cmH₂O. Higher values indicate greater respiratory muscle strength.
Health-Related Quality of Life assessed by the 36-Item Short Form Health Surveyfor 6 weeksIt includes eight domains (physical functioning, role limitations, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Scores are transformed to a 0-100 scale, where 0 = worst health and 100 = best health. Higher scores indicate better health-related quality of life.

Countries

Egypt

Contacts

Primary ContactSameh Eldaly Sameh Eldaly
info@sameheldaly.online+201554076441

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026