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Intradialytic Versus Home-Based Exercise in Female Hemodialysis Patients

16. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

90

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

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

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
  • Eldre voksen

Tar imot friske frivillige

Nei

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

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

Hvordan er studiet utformet?

Designdetaljer

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

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Eksperimentell: 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.
Atferdsmessig: 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 inngripen: Control
Participants continued their usual hemodialysis care without a structured exercise program during the 12-week study period.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

Tanta University

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 (Faktiske)

1. mars 2025

Primær fullføring (Faktiske)

1. juni 2025

Studiet fullført (Faktiske)

1. juni 2025

Datoer for studieregistrering

Først innsendt

16. juli 2026

Først innsendt som oppfylte QC-kriteriene

16. juli 2026

Først lagt ut (Faktiske)

21. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 36264PR1100/2/25

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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