Combining Moderate Aerobic Exercise With Inspiratory Muscle Training for Dialysis Patients With Atrial

NCT07827274 — Not applicable, Not yet recruiting, 45 participants, Beni-Suef University

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Antiremodelling Effect of Moderate Intensity Aerobic Combined With Inspiratory Muscle Trainings on Kidney Dialysis With Atrial Fibrillation

Registry	NCT07827274
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	45 (Estimated)
Sponsor	Beni-Suef University (Other)
Conditions	Atrial Fibrillation (AF)
Interventions	inspiratoy muscle training, Aerobic exercise +inspiratory muscle training (Device)
Dates	start 2026-09-20 (estimated), primary completion 2027-03-20 (estimated), completion 2027-03-23 (estimated), first posted 2026-09-18, last updated 2026-09-18

-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 hemodialysis CKD patients with atrial fibrillation as regards The following outcomes:

1. medical state of patient (heart rate, blood pressure, oxygen saturation)
2. lab analysis (GFR, Serum creatinine, blood urea and nitrogen (BUN) and INR)
3. maximum Inspiratory pressure (MIP)
4. period, duration of dialysis
5. short form questionnaire(SF36)
6. modified Borg scale

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+Arms and interventions

Arm	Type	Interventions	Description
group A inspiratory muscle training	Active comparator	Device: inspiratoy muscle training	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
group B (Aerobic exercise+inspiratory muscle trainig )	Active comparator	Device: inspiratoy muscle training; Device: Aerobic exercise +inspiratory muscle training	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)
control group c receive medical only	No intervention		no exercise this group do assessment pre and post 3 months

inspiratoy muscle training (Device): 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 training (Device): 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)

+Outcome measures

Primary outcomes

6 minute walk test [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

+Eligibility

Sex: All, ages: 40 Years to 60 Years

Inclusion Criteria

* 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
* 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

+Investigators

sherien H mehani, professor, Principal investigator, Beni _suef