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Intradialytic Versus Home-Based Exercise in Female Hemodialysis Patients

16. juli 2026 opdateret af: Hebatuallah Abdelhaleem Elhabiby, Tanta University

Comparing the Effect of Intradialytic and Home-Based Exercise on Health Outcomes, Quality of Life, Self-Esteem, and Sexual Function in Female Hemodialysis Patients

This randomized controlled trial compared intradialytic exercise with home-based exercise in married female patients receiving maintenance hemodialysis. Ninety participants were randomly assigned in equal numbers to an intradialytic exercise group, a home-based exercise group, or a control group. Both exercise programs continued for 12 weeks.

The study evaluated whether exercise performed during dialysis or at home could improve quality of life, self-esteem, sexual function, and selected clinical and laboratory outcomes. Quality of life was assessed using the 36-Item Short Form Survey, self-esteem using the Rosenberg Self-Esteem Scale, and sexual function using the Female Sexual Function Index. Laboratory assessments included calcium, phosphorus, intact parathyroid hormone, albumin, C-reactive protein, hemoglobin, sodium, and potassium.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Egypten
    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egypten, 31511
        • Tanta University Hospitals

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Female patients older than 18 years.
  • Clinically stable.
  • Receiving regular maintenance hemodialysis three times per week for at least three months.
  • Able to perform mild- to moderate-intensity exercise.

Exclusion Criteria:

  • Physical limitations preventing exercise.
  • Acute illness.
  • Unstable cardiovascular disease.
  • Severe orthopedic or neurological disorders.
  • Cognitive impairment affecting cooperation.
  • Dialysis instability.
  • Severe chronic kidney disease-mineral and bone disorder.
  • Significant anemia.
  • Retinal hemorrhage.
  • History of hyperthyroidism.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intradialytic Exercise
Participants performed low- to moderate-intensity aerobic and resistance exercises during the first two hours of hemodialysis, three times per week for 12 weeks. Each session included a 5-minute warm-up, followed by aerobic and resistance exercises. The conditioning phase started at 10 minutes and gradually increased to 30 minutes according to tolerance, followed by 5 minutes of relaxation and breathing exercises. Exercise intensity was maintained at 60%-70% of maximal heart rate and monitored using the Borg scale. Sessions were supervised by a trained dialysis nurse.
Adfærdsmæssigt: Intradialytic Exercise
A supervised low- to moderate-intensity aerobic and resistance exercise program performed during the first two hours of hemodialysis, three times per week for 12 weeks.
Eksperimentel: Home-Based Exercise
Participants performed a structured home-based exercise program for 30 minutes per day, at least three to five times per week, for 12 weeks. The program included walking, bodyweight resistance exercises, and flexibility routines. Participants received instructions on safe exercise performance and were advised to adjust the exercise intensity according to tolerance.
Adfærdsmæssigt: Home-Based Exercise
A structured home-based exercise program consisting of walking, bodyweight resistance exercises, and flexibility routines for 30 minutes per day, at least three to five times per week for 12 weeks.
Ingen indgriben: Control
Participants continued their usual hemodialysis care without a structured exercise program during the 12-week study period.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Health-Related Quality of Life
Tidsramme: Baseline and 12 weeks
Change in Health-Related Quality of Life was assessed by the 36-Item Short Form Survey. The 36-Item Short Form Survey consists of 36 items covering eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, energy/fatigue, social functioning, role limitations due to emotional problems, and emotional well-being. Each domain is scored from 0 to 100, with 0 representing the lowest possible health status and 100 representing the highest possible health status. Higher scores indicate better health-related quality of life. The validated Arabic version was used.
Baseline and 12 weeks
Self-Esteem
Tidsramme: Baseline and 12 weeks
Change in Self-Esteem was assessed by the Rosenberg Self-Esteem Scale. The Rosenberg Self-Esteem Scale consists of 10 items assessing global self-esteem, including five positively worded and five negatively worded statements. Higher total scores indicate higher self-esteem.
Baseline and 12 weeks
Female sexual function
Tidsramme: Baseline and 12 weeks
Change in Female Sexual Function was assessed by the Female Sexual Function Index. The Female Sexual Function Index consists of 19 items covering six domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. The total score ranges from 2 to 36, with higher scores indicating better sexual function. The validated Arabic version was used.
Baseline and 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tanta University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2025

Primær færdiggørelse (Faktiske)

1. juni 2025

Studieafslutning (Faktiske)

1. juni 2025

Datoer for studieregistrering

Først indsendt

16. juli 2026

Først indsendt, der opfyldte QC-kriterier

16. juli 2026

Først opslået (Faktiske)

21. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 36264PR1100/2/25

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data underlying the results reported in the publication will be made available to other researchers upon reasonable request.

IPD-delingstidsramme

Beginning immediately after publication of the study results and continuing for 2 years.

IPD-delingsadgangskriterier

De-identified individual participant data will be available to researchers who submit a methodologically sound proposal. Requests should be directed to the corresponding author at hebaelhabiby@gmail.com. Requests will be reviewed by the study investigators, and approved data will be provided for the purposes specified in the proposal, subject to an appropriate data use agreement.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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