NCT07827274

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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 Progress8%
Sep 2026Mar 2027

First Submitted

Initial submission to the registry

September 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

September 20, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2027

Expected
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2027

Last Updated

September 18, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

September 14, 2026

Last Update Submit

September 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    at the start of study and after intervention (3months)

Study Arms (3)

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

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)

Device: inspiratoy muscle trainingDevice: Aerobic exercise +inspiratory muscle training

control group c receive medical only

NO INTERVENTION

no exercise this group do assessment pre and post 3 months

Interventions

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

group A inspiratory muscle traininggroup B (Aerobic exercise+inspiratory muscle trainig )

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)

group B (Aerobic exercise+inspiratory muscle trainig )

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • sherien H mehani, professor

    Beni _suef

    PRINCIPAL INVESTIGATOR

Central Study Contacts

eman M abdallah, master degree

CONTACT

mahmoud I mahmoud, lecturer

CONTACT

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
physiotherapist

Study Record Dates

First Submitted

September 14, 2026

First Posted

September 18, 2026

Study Start

September 20, 2026

Primary Completion (Estimated)

March 20, 2027

Study Completion (Estimated)

March 23, 2027

Last Updated

September 18, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share