Atrial Fibrillation (AF)NCT07827274
Combining Moderate Aerobic Exercise With Inspiratory Muscle Training for Dialysis Patients With Atrial
A study testing inspiratoy muscle training and Aerobic exercise +inspiratory muscle training in people with Atrial Fibrillation (AF), run by Beni-Suef University.
Trial summary
Statement of the problem: Is there a difference between of inspiratory muscle training with aerobic exercise or inspiratory muscle training for hemodialysis patients with AF?? Purpose of the study: To find out the effect of combined inspiratory muscle training with aerobic exercise OR inspiratorty muscle traiting for… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- inspiratoy muscle training and Aerobic exercise +inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 23 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients from both gender
- With chronic kidney failure(GFR>30)
- with atrial fibrillation
- Unemployed living a sedentary lifestyle
- Receive regular hemodialysis sessions at 2months ago
- All of them have vascular access through arteriovenous fistula
Show all 21Show fewer
- Age range from 40-60 years
- Fully understand purpose and procedure of study
- Stable and have sufficient level of cognition and ability to understand instructions
- exclusion Criteria: Patients who meet one of the following criteria will be excluded
- Real difficulties with understanding and signing The written informed consent
- Recent sequela of cerebrovascular accidents
- Osteoarticular or musculoskeletal diseases
- Un controlled systemic hypertension
- Un controlled diabetes
- Un stable angina
- Fever
- Infectious disease
- Acute respiratory failure
- Recent acute myocardial infarction
- Peripheral vascular diseases
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Antiremodelling Effect of Moderate Intensity Aerobic Combined With Inspiratory Muscle Trainings on Kidney Dialysis With Atrial Fibrillation
Statement of the problem:
Is there a difference between of inspiratory muscle training with aerobic exercise or inspiratory muscle training for hemodialysis patients with AF??
Purpose of the study:
To find out the effect of combined inspiratory muscle training with aerobic exercise OR inspiratorty muscle traiting for hemodialysis CKD patients with atrial fibrillation as regards The following outcomes:
- medical state of patient (heart rate, blood pressure, oxygen saturation)
- lab analysis (GFR, Serum creatinine, blood urea and nitrogen (BUN) and INR)
- maximum Inspiratory pressure (MIP)
- period, duration of dialysis
- short form questionnaire(SF36)
- modified Borg scale
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- inspiratoy muscle training, Aerobic exercise +inspiratory muscle training
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratoy muscle trainingDevice
intervention : (inspiratory muscle training) (inspiratory muscle training at 30% of maximal inspiratory pressure for20 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted 30% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set. The resistance was adjusted every month at 30%of the new maximum pressura and if it remain the subject remain at the same level
Aerobic exercise +inspiratory muscle trainingDevice
- Active phase:
- Mode:moderte -intensity interval aerobic training (MIIT).
- Intensity: With MODERTE intensity continous of 60 %of heart rate reserve (HRR) monitored by ECG and a 5-minute cool-down following exercise at intensity (30- 40%HR RESERVE) were carried out each time.
In addition, the exercise was performed in the first half of the dialysis session over a 3 months period for 3 sessions per week by cycling for 20 min at a moderate intensity(60%HR RESERVE) participants were trained to use stationary bicycle ergometer in a supine position for minimum of 30 minutes at each HD session.
The speed, load, and duration were gradually increased with change of mode (automatic and passive).
inspiratory muscle training)
| Study group | Role | What they receive |
|---|---|---|
| group A inspiratory muscle training | Active comparator | intervention device(inspiratory muscle training) (inspiratory muscle trainingat 30% of maximal inspiratory pressure for20 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted 30% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set. The resistance was adjusted every month at 30%of the new maximum pressura and if it remain the subject remain at the same level Receives: Device: inspiratoy muscle training |
| group B (Aerobic exercise+inspiratory muscle trainig ) | Active comparator | interventions device ( Aerobic exercise +inspiratory muscle training)
Aerobic exercise only 5-minute warm-up before exercise Each session started with a 5-minute bicycling warmup at 30%- 40% of HRR b) Active phase:
* Mode:moderte -intensity interval aerobic training (MIIT).
* Intensity: With MODERTE intensity continous of 60 %of heart rate reserve (HRR) monitored by ECG and a 5-minute cool-down following exercise at intensity (30- 40%HR RESERVE) were carried out each time.
In addition, the exercise was performed in the first half of the dialysis session over a 3 months period for 3 sessions per week by cycling for 20 min at a moderate intensity(60%HR RESERVE) participants were trained to use stationary bicycle ergometer in a supine position for minimum of 30 minutes at each HD session.
The speed, load, and duration were gradually increased with change of mode (automatic and passive).
inspiratory muscle training) Receives: Device: inspiratoy muscle training; Device: Aerobic exercise +inspiratory muscle training |
| control group c receive medical only | No intervention | no exercise this group do assessment pre and post 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
6 minute walk test : (To detect functional capacity, carry out in a 20 -meter line along The passage way, The tape is placed every 30 meters
.patients are instructed to walk The longest possible distance in 6 minutes continuously, turning around at The final Mark without stopping. they are further instructed to walk as far as they can for 6minutes without running or jogging, covered distance in meters is measured at the end of the rest for analysis
Measured: at the start of study and after intervention (3months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion20 Mar 2027 (estimated)
- Study completion23 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, eman mohamed ahmed abdallah, Beni-Suef University
- Investigators
- sherien H mehani, professor, Principal investigator, Beni _suef
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827274
- Sponsor's protocol ID
- AF in Hemodialysis
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- 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
- Antiremodelling Effect of Moderate Intensity Aerobic Combined With Inspiratory Muscle Trainings on Kidney Dialysis With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07827274
- Acronym / sponsor ID
- AF in Hemodialysis
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 23 Mar 2027 (estimated)
- First posted
- 18 Sep 2026 (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.
Statement of the problem:
Is there a difference between of inspiratory muscle training with aerobic exercise or inspiratory muscle training for hemodialysis patients with AF??
Purpose of the study:
To find out the effect of combined inspiratory muscle training with aerobic exercise OR inspiratorty muscle traiting for hemodialysis CKD patients with atrial fibrillation as regards The following outcomes:
- medical state of patient (heart rate, blood pressure, oxygen saturation)
- lab analysis (GFR, Serum creatinine, blood urea and nitrogen (BUN) and INR)
- maximum Inspiratory pressure (MIP)
- period, duration of dialysis
- short form questionnaire(SF36)
- modified Borg scale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A inspiratory muscle training | Active comparator | Device: inspiratoy muscle trainingintervention device(inspiratory muscle training) (inspiratory muscle trainingat 30% of maximal inspiratory pressure for20 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted 30% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set. The resistance was adjusted every month at 30%of the new maximum pressura and if it remain the subject remain at the same level |
| group B (Aerobic exercise+inspiratory muscle trainig ) | Active comparator | Device: inspiratoy muscle training, Device: Aerobic exercise +inspiratory muscle traininginterventions device ( Aerobic exercise +inspiratory muscle training) Aerobic exercise only 5-minute warm-up before exercise Each session started with a 5-minute bicycling warmup at 30%- 40% of HRR b) Active phase: * Mode:moderte -intensity interval aerobic training (MIIT). * Intensity: With MODERTE intensity continous of 60 %of heart rate reserve (HRR) monitored by ECG and a 5-minute cool-down following exercise at intensity (30- 40%HR RESERVE) were carried out each time. In addition, the exercise was performed in the first half of the dialysis session over a 3 months period for 3 sessions per week by cycling for 20 min at a moderate intensity(60%HR RESERVE) participants were trained to use stationary bicycle ergometer in a supine position for minimum of 30 minutes at each HD session. The speed, load, and duration were gradually increased with change of mode (automatic and passive). inspiratory muscle training) |
| control group c receive medical only | No intervention | –no exercise this group do assessment pre and post 3 months |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Patients from both gender
- With chronic kidney failure(GFR>30)
- with atrial fibrillation
- Unemployed living a sedentary lifestyle
- Receive regular hemodialysis sessions at 2months ago
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| inspiratoy muscle trainingintervention : (inspiratory muscle training) (inspiratory muscle training at 30% of maximal inspiratory pressure for20 minutes/ session, 3 days a week, for 3 months Each patient breathes through a separate mouthpiece. The resistance is adjusted 30% of maximum inspiratory pressure detected from maximum inspiratory pressure meter and is marked on the training device. A single training session consists of five sets, each contains five inspirations with total of twenty five breaths with one minute of recovery between each set. The resistance was adjusted every month at 30%of the new maximum pressura and if it remain the subject remain at the same level | Device | group A inspiratory muscle training, group B (Aerobic exercise+inspiratory muscle trainig ) |
| Aerobic exercise +inspiratory muscle trainingb) Active phase: * Mode:moderte -intensity interval aerobic training (MIIT). * Intensity: With MODERTE intensity continous of 60 %of heart rate reserve (HRR) monitored by ECG and a 5-minute cool-down following exercise at intensity (30- 40%HR RESERVE) were carried out each time. In addition, the exercise was performed in the first half of the dialysis session over a 3 months period for 3 sessions per week by cycling for 20 min at a moderate intensity(60%HR RESERVE) participants were trained to use stationary bicycle ergometer in a supine position for minimum of 30 minutes at each HD session. The speed, load, and duration were gradually increased with change of mode (automatic and passive). inspiratory muscle training) | Device | group B (Aerobic exercise+inspiratory muscle trainig ) |
Primary outcome
6 minute walk test
Time frame: at the start of study and after intervention (3months)
6 minute walk test : (To detect functional capacity, carry out in a 20 -meter line along The passage way, The tape is placed every 30 meters .patients are instructed to walk The longest possible distance in 6 minutes continuously, turning around at The final Mark without stopping. they are further instructed to walk as far as they can for 6minutes without running or jogging, covered distance in meters is measured at the end of the rest for analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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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.
sherien H mehani, professor principal investigator
Beni _suef
Questions about this trial
What is this clinical trial studying?
A study testing inspiratoy muscle training and Aerobic exercise +inspiratory muscle training in people with Atrial Fibrillation (AF), run by Beni-Suef University.
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 21 inclusion and 0 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: opening soon, 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.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact eman M abdallah, master degree (00201000665383, emem43332@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walk test (time frame: at the start of study and after intervention (3months)). 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.