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

14 septembre 2026 mis à jour par: eman mohamed ahmed abdallah, Beni-Suef University

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:

  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

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Estimé)

45

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: eman M abdallah, master degree
  • Numéro de téléphone: 00201000665383
  • E-mail: emem43332@gmail.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: group A inspiratory 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
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
Comparateur actif: group B (Aerobic exercise+inspiratory muscle trainig )

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)

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

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)

Aucune intervention: control group c receive medical only
no exercise this group do assessment pre and post 3 months

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
6 minute walk test
Délai: 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

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: sherien H mehani, professor, Beni _suef

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

20 septembre 2026

Achèvement primaire (Estimé)

20 mars 2027

Achèvement de l'étude (Estimé)

23 mars 2027

Dates d'inscription aux études

Première soumission

14 septembre 2026

Première soumission répondant aux critères de contrôle qualité

14 septembre 2026

Première publication (Réel)

18 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • AF in Hemodialysis

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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