HemodialysisNCT07183696
Respiratory Muscle Training and Quality of Life in Hemodialysis Patients
A study testing breathing exercises in people with Hemodialysis, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- breathing exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Breath Booster Training on Respiratory Muscle Strength 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.
Read the 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
- Being tested
- breathing exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breathing exercisesOther
Also called chest percussion, vibration
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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 Receives: Other: breathing exercises |
| Intervention Group | Experimental | 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 Receives: Other: breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Oct 2024
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Eldaly, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183696
- Sponsor's protocol ID
- P.T.REC/012/005826
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breath Booster Training on Respiratory Muscle Strength and Quality of Life in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07183696
- Acronym / sponsor ID
- P.T.REC/012/005826
- Conditions
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: breathing exerciseswill 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 | Experimental | Other: breathing exerciseswill 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 |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breathing exercisesAlso: chest percussion, vibration* 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 | Intervention Group, Placebo |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Hemodialysis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breathing exercises in people with Hemodialysis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Muscle Strength measured using Respiratory Pressure Manometers (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.