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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2024
CompletedFirst Submitted
Initial submission to the registry
September 11, 2025
CompletedFirst Posted
Study publicly available on registry
September 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedSeptember 19, 2025
September 1, 2025
1 year
September 11, 2025
September 18, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Respiratory Muscle Strength measured using Respiratory Pressure Manometers
Outcomes include maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), recorded in cmH₂O. Higher values indicate greater respiratory muscle strength.
6 weeks
Health-Related Quality of Life assessed by the 36-Item Short Form Health Survey
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.
for 6 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORwill 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
Intervention Group
EXPERIMENTALwill 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
Interventions
* 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of physical therapy cairo university
Giza, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director of scientific research committee
Study Record Dates
First Submitted
September 11, 2025
First Posted
September 19, 2025
Study Start
October 1, 2024
Primary Completion
October 1, 2025
Study Completion
October 1, 2025
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share