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Intradialytic Versus Home-Based Exercise in Female Hemodialysis Patients

16 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

90

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Experimenteel: 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.
Gedragsmatig: 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.
Geen tussenkomst: Control
Participants continued their usual hemodialysis care without a structured exercise program during the 12-week study period.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Health-Related Quality of Life
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Tanta University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 maart 2025

Primaire voltooiing (Werkelijk)

1 juni 2025

Studie voltooiing (Werkelijk)

1 juni 2025

Studieregistratiedata

Eerst ingediend

16 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

16 juli 2026

Eerst geplaatst (Werkelijk)

21 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

16 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 36264PR1100/2/25

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

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

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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