Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07183696

Respiratory Muscle Training and Quality of Life in Hemodialysis Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

50 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy cairo university

Giza, Egypt

Location status: Recruiting

Location contact

Amal yousef, Phd

CONTACT

[email protected]

37617691

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fifty patients will be included in this study.
  • Their ages will range from 50 to 60 years.
  • Patients with end-stage renal disease (grade 5) receiving hemodialysis.
  • Patients on hemodialysis for around 1 to 3 years.
  • They will be able to follow instructions during evaluation and treatment.

Exclusion criteria

  • Diabetes Mellitus,
  • Morbid obesity with a BMI of more than 35 kg/m2.
  • Hearing or visual impairments.
  • Any severe chest diseases like COPD.
  • 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
  • Uncontrolled seizures.

Treatment and study plan

Breathing exercises

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.

Other names: chest percussion, vibration

Primary outcomes

  1. Respiratory Muscle Strength measured using Respiratory Pressure Manometers

    Time frame: 6 weeks

    Outcomes include maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), recorded in cmH₂O. Higher values indicate greater respiratory muscle strength.

  2. Health-Related Quality of Life assessed by the 36-Item Short Form Health Survey

    Time frame: for 6 weeks

    It 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sameh Eldaly Sameh Eldaly

CONTACT

[email protected]

+201554076441

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.