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

14 de septiembre de 2026 actualizado por: 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

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

45

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: eman M abdallah, master degree
  • Número de teléfono: 00201000665383
  • Correo electrónico: emem43332@gmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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
Comparador activo: 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)

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
6 minute walk test
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

20 de septiembre de 2026

Finalización primaria (Estimado)

20 de marzo de 2027

Finalización del estudio (Estimado)

23 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

14 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Publicado por primera vez (Actual)

18 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • AF in Hemodialysis

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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