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Physical Exercise in Patients With Chronic Kidney Disease in Hemodialysis (Pehedal-ESKD) (Pehedal-ESKD)

14 septembre 2026 mis à jour par: Ricerca Nefrocenter

Physical Exercise in Hemodialysis Patients in End Stage Kidney Disease

The goal of this clinical trial is to learn whether different types of exercise performed during hemodialysis are safe, well tolerated, and beneficial for adults receiving maintenance hemodialysis. The main questions it aims to answer are:

  • Are aerobic exercise using a cycle ergometer and resistance exercise using elastic bands well tolerated during hemodialysis?
  • Do these exercise programs improve physical function, body composition, quality of life, and dialysis-related outcomes compared with standard care?

Researchers will compare aerobic exercise, resistance exercise, and standard hemodialysis care to evaluate differences in tolerance and health outcomes.

Participants will:

  • Be assigned to one of three groups: cycle ergometer exercise, elastic-band resistance exercise, or standard care.
  • Attend hemodialysis sessions as scheduled.
  • Complete physical performance and body composition assessments at baseline and after 6 months.
  • Complete questionnaires about health and quality of life.

The results of this study may help identify effective exercise strategies to improve health and well-being in people receiving long-term hemodialysis treatment.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

312

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.

Coordonnées de l'étude

Lieux d'étude

  • Italie
      • Torre del Greco, Italie, 80059
        • Recrutement
        • NefroCenter Dialysis Centers
        • Contact:
        • Chercheur principal:
          • Ersilia Satta, PhD MD

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:

  • Age ≥18 years.
  • Receiving maintenance hemodialysis for more than 3 months.
  • Clinically stable condition.
  • Ability and willingness to provide written informed consent.

Exclusion Criteria:

  • Unstable angina.
  • Uncontrolled hypertension.
  • Any medical condition judged by the treating nephrologist to contraindicate or make intradialytic exercise unsafe

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
Comparateur actif: Cycle ergometer
Participants performed supervised intradialytic aerobic exercise using a cycle ergometer during the first 2 hours of hemodialysis sessions. Exercise was conducted three times per week for a total of 150 minutes per week at moderate intensity, corresponding to a Borg Rating of Perceived Exertion of 12-13. Training sessions were supervised by qualified exercise professionals and monitored by dialysis nurses to ensure safety and adherence.
Comportemental: Intradialytic aerobic exercise using a cycle ergometer
Participants performed supervised intradialytic aerobic exercise using a cycle ergometer during the first 2 hours of hemodialysis sessions. Exercise was conducted three times weekly for a total of 150 minutes per week at moderate intensity (Borg Rating of Perceived Exertion 12-13). Sessions were supervised by exercise professionals and monitored by dialysis nurses to ensure safety and adherence.
Comparateur actif: Elastic band resistance training
Participants performed supervised intradialytic resistance exercise using progressive color-coded elastic bands during the first 2 hours of hemodialysis sessions. Training was conducted three times per week for a total of 150 minutes per week at moderate intensity and targeted both upper and lower limbs. Resistance was progressively adjusted according to individual tolerance and correct exercise execution. Sessions were supervised by exercise professionals and monitored by dialysis nurses.
Comportemental: Intradialytic elastic-band resistance exercise
Participants performed supervised intradialytic resistance exercise using progressive color-coded elastic bands during the first 2 hours of hemodialysis sessions. Training was conducted three times weekly for a total of 150 minutes per week at moderate intensity and targeted both upper and lower limbs. Resistance levels were progressively adjusted according to individual tolerance and proper exercise execution.
Aucune intervention: Control
Participants received standard hemodialysis care and continued their usual activities during dialysis sessions without participation in a structured intradialytic exercise program. Clinical assessments and follow-up evaluations were performed according to the study protocol.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of intradialytic intolerance and hemodynamic instability
Délai: Baseline to 6 months
Exercise tolerability will be evaluated through the incidence of intradialytic intolerance events and the maintenance of hemodynamic stability during hemodialysis sessions. Hemodynamic monitoring will include systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate measured before, during, and after exercise sessions. Clinical signs and symptoms of exercise intolerance, including hypotension, dizziness, muscle cramps, nausea, premature interruption of exercise, or other adverse events occurring during dialysis, will be recorded. Outcomes will be compared among cycle ergometer exercise, elastic-band resistance training, and combined exercise programs to assess the relative tolerability and safety of each intervention.
Baseline to 6 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Maximal workload during cycle ergometer stress testing
Délai: Baseline to 6 months
Changes in maximal workload achieved during cycle ergometer stress testing.
Baseline to 6 months
Six-minute walk test distance
Délai: Baseline and 6 months
Changes in distance covered during the 6-minute walk test as a measure of functional exercise capacity.
Baseline and 6 months
Step-test performance
Délai: Baseline and 6 months
Changes in step-test performance as an indicator of functional mobility and lower-limb performance.
Baseline and 6 months
Chair-stand test performance
Délai: Baseline and 6 months
Changes in the number of repetitions completed during the chair-stand test as a measure of lower-limb muscle function.
Baseline and 6 months
Handgrip strength
Délai: Baseline and 6 months
Changes in handgrip strength measured using a hand dynamometer.
Baseline and 6 months
Weekly exercise time
Délai: Throughout the 6-month intervention period
Changes in the total amount of exercise completed per week during the intervention period.
Throughout the 6-month intervention period
Fat-free mass and fat mass
Délai: Baseline to 6 months
Changes in fat-free mass and fat mass assessed by bioelectrical impedance analysis, both reported as percentage of body weight.
Baseline to 6 months
Bone mineral content
Délai: Baseline and 6 months
Changes in bone mineral content assessed by radiofrequency echographic multi-spectrometry (REMS).
Baseline and 6 months
Bone mineral status (T-score)
Délai: Baseline and 6 months
Changes in T-score as an indicator of bone mineral status.
Baseline and 6 months
Appendicular skeletal muscle mass index (ASMMI)
Délai: Baseline and 6 months
Changes in appendicular skeletal muscle mass index (ASMMI) as a measure of skeletal muscle mass.
Baseline and 6 months
Anthropometric circumferences
Délai: Baseline and 6 months
Changes in upper-limb, lower-limb, and trunk circumferences measured using standardized anthropometric procedures.
Baseline and 6 months
Health-related quality of life
Délai: Baseline to 6 months
Changes in health-related quality of life assessed using the Sarcopenia Quality of Life (SARQoL) questionnaire. The SARQoL questionnaire generates an overall score ranging from 0 to 100, with higher scores indicating better quality of life.
Baseline to 6 months
Medication burden
Délai: Baseline to 6 months
Changes in the number of prescribed medications and antihypertensive drugs between baseline and follow-up.
Baseline to 6 months
Dialysis adequacy
Délai: Baseline to 6 months
Changes in dialysis adequacy expressed as Kt/V.
Baseline to 6 months
Dialysis session duration
Délai: Baseline and 6 months
Changes in the duration of the hemodialysis session (min).
Baseline and 6 months
Blood flow rate
Délai: Baseline and 6 months
Changes in blood flow rate (Qb) during hemodialysis.
Baseline and 6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ricerca Nefrocenter

Collaborateurs

Federico II University
University of Naples

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

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 juin 2024

Achèvement primaire (Réel)

1 octobre 2025

Achèvement de l'étude (Estimé)

1 mars 2027

Dates d'inscription aux études

Première soumission

24 août 2026

Première soumission répondant aux critères de contrôle qualité

14 septembre 2026

Première publication (Réel)

15 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 0079556CE
  • CUP E63C22002050006 (Autre subvention/numéro de financement: National Recovery and Resilience Plan (PNRR), Age-It - Spoke 4)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Description du régime IPD

The decision regarding sharing of individual participant data (IPD) has not yet been finalized. Data sharing will be evaluated after study completion, taking into account ethical, legal, privacy, and data protection requirements.

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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