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

14 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

312

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.

Studiecontact

Studie Locaties

  • Italië
      • Torre del Greco, Italië, 80059
        • Werving
        • NefroCenter Dialysis Centers
        • Contact:
        • Hoofdonderzoeker:
          • Ersilia Satta, PhD MD

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:

  • 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

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
Actieve vergelijker: 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.
Gedragsmatig: 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.
Actieve vergelijker: 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.
Gedragsmatig: 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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of intradialytic intolerance and hemodynamic instability
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Maximal workload during cycle ergometer stress testing
Tijdsspanne: Baseline to 6 months
Changes in maximal workload achieved during cycle ergometer stress testing.
Baseline to 6 months
Six-minute walk test distance
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline and 6 months
Changes in handgrip strength measured using a hand dynamometer.
Baseline and 6 months
Weekly exercise time
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline to 6 months
Changes in dialysis adequacy expressed as Kt/V.
Baseline to 6 months
Dialysis session duration
Tijdsspanne: Baseline and 6 months
Changes in the duration of the hemodialysis session (min).
Baseline and 6 months
Blood flow rate
Tijdsspanne: Baseline and 6 months
Changes in blood flow rate (Qb) during hemodialysis.
Baseline and 6 months

Medewerkers en onderzoekers

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

Sponsor

Ricerca Nefrocenter

Medewerkers

Federico II University
University of Naples

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

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 juni 2024

Primaire voltooiing (Werkelijk)

1 oktober 2025

Studie voltooiing (Geschat)

1 maart 2027

Studieregistratiedata

Eerst ingediend

24 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 september 2026

Eerst geplaatst (Werkelijk)

15 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 september 2026

Laatste update ingediend die voldeed aan QC-criteria

14 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 0079556CE
  • CUP E63C22002050006 (Ander subsidie-/financieringsnummer: National Recovery and Resilience Plan (PNRR), Age-It - Spoke 4)

Plan Individuele Deelnemersgegevens (IPD)

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

ONBESLIST

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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