Intradialytic Versus Home-Based Exercise in Female Hemodialysis Patients
16 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
90
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Gharbia Governorate
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Tanta, Gharbia Governorate, Egypte, 31511
- Tanta University Hospitals
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
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Expérimental: 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.
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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.
|
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Aucune intervention: Control
Participants continued their usual hemodialysis care without a structured exercise program during the 12-week study period.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Health-Related Quality of Life
Délai: 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.
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Baseline and 12 weeks
|
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Self-Esteem
Délai: 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
Délai: 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.
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Baseline and 12 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 mars 2025
Achèvement primaire (Réel)
1 juin 2025
Achèvement de l'étude (Réel)
1 juin 2025
Dates d'inscription aux études
Première soumission
16 juillet 2026
Première soumission répondant aux critères de contrôle qualité
16 juillet 2026
Première publication (Réel)
21 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Processus pathologiques
- Maladies urogénitales masculines
- Maladies rénales
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladie chronique
- Attributs de la maladie
- Insuffisance rénale
- Insuffisance rénale chronique
- Conditions pathologiques, signes et symptômes
- Comportement
- Insuffisance rénale chronique
- Activité motrice
Autres numéros d'identification d'étude
- 36264PR1100/2/25
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
De-identified individual participant data underlying the results reported in the publication will be made available to other researchers upon reasonable request.
Délai de partage IPD
Beginning immediately after publication of the study results and continuing for 2 years.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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