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

14. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

312

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Italia
      • Torre del Greco, Italia, 80059
        • Rekruttering
        • NefroCenter Dialysis Centers
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ersilia Satta, PhD MD

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:

  • 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

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
Aktiv komparator: 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.
Atferdsmessig: 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.
Aktiv komparator: 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.
Atferdsmessig: 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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of intradialytic intolerance and hemodynamic instability
Tidsramme: 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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

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

Sponsor

Ricerca Nefrocenter

Samarbeidspartnere

Federico II University
University of Naples

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

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. juni 2024

Primær fullføring (Faktiske)

1. oktober 2025

Studiet fullført (Antatt)

1. mars 2027

Datoer for studieregistrering

Først innsendt

24. august 2026

Først innsendt som oppfylte QC-kriteriene

14. september 2026

Først lagt ut (Faktiske)

15. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 0079556CE
  • CUP E63C22002050006 (Annet stipend/finansieringsnummer: National Recovery and Resilience Plan (PNRR), Age-It - Spoke 4)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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