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

14. september 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

45

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: eman M abdallah, master degree
  • Telefonnummer: 00201000665383
  • E-post: emem43332@gmail.com

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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
Enhet: inspiratoy 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
Aktiv komparator: 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)
Enhet: inspiratoy 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
Enhet: Aerobic exercise +inspiratory muscle training

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)
Ingen inngripen: control group c receive medical only
no exercise this group do assessment pre and post 3 months

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
6 minute walk test
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Beni-Suef University

Etterforskere

  • Hovedetterforsker: sherien H mehani, professor, Beni _suef

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

20. september 2026

Primær fullføring (Antatt)

20. mars 2027

Studiet fullført (Antatt)

23. mars 2027

Datoer for studieregistrering

Først innsendt

14. september 2026

Først innsendt som oppfylte QC-kriteriene

14. september 2026

Først lagt ut (Faktiske)

18. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AF in Hemodialysis

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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