Physical Exercise in Patients With Chronic Kidney Disease in Hemodialysis (Pehedal-ESKD) (Pehedal-ESKD)
14. September 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Studientyp
Interventionell
Einschreibung (Geschätzt)
312
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Ersilia Satta, PhD MD
- Telefonnummer: +39 3395703091
- E-Mail: e.satta@consorzionefrocenter.it
Studienorte
-
-
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Torre del Greco, Italien, 80059
- Rekrutierung
- NefroCenter Dialysis Centers
-
Kontakt:
- Study Coordinator, PhD
- Telefonnummer: +39 3395703091
- E-Mail: e.satta@consorzionefrocenter.it
-
Hauptermittler:
- Ersilia Satta, PhD MD
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver 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.
|
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.
|
|
Aktiver 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.
|
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.
|
|
Kein Eingriff: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of intradialytic intolerance and hemodynamic instability
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Maximal workload during cycle ergometer stress testing
Zeitfenster: Baseline to 6 months
|
Changes in maximal workload achieved during cycle ergometer stress testing.
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Baseline to 6 months
|
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Six-minute walk test distance
Zeitfenster: Baseline and 6 months
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Changes in distance covered during the 6-minute walk test as a measure of functional exercise capacity.
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Baseline and 6 months
|
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Step-test performance
Zeitfenster: Baseline and 6 months
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Changes in step-test performance as an indicator of functional mobility and lower-limb performance.
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Baseline and 6 months
|
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Chair-stand test performance
Zeitfenster: Baseline and 6 months
|
Changes in the number of repetitions completed during the chair-stand test as a measure of lower-limb muscle function.
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Baseline and 6 months
|
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Handgrip strength
Zeitfenster: Baseline and 6 months
|
Changes in handgrip strength measured using a hand dynamometer.
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Baseline and 6 months
|
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Weekly exercise time
Zeitfenster: Throughout the 6-month intervention period
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Changes in the total amount of exercise completed per week during the intervention period.
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Throughout the 6-month intervention period
|
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Fat-free mass and fat mass
Zeitfenster: Baseline to 6 months
|
Changes in fat-free mass and fat mass assessed by bioelectrical impedance analysis, both reported as percentage of body weight.
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Baseline to 6 months
|
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Bone mineral content
Zeitfenster: Baseline and 6 months
|
Changes in bone mineral content assessed by radiofrequency echographic multi-spectrometry (REMS).
|
Baseline and 6 months
|
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Bone mineral status (T-score)
Zeitfenster: Baseline and 6 months
|
Changes in T-score as an indicator of bone mineral status.
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Baseline and 6 months
|
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Appendicular skeletal muscle mass index (ASMMI)
Zeitfenster: Baseline and 6 months
|
Changes in appendicular skeletal muscle mass index (ASMMI) as a measure of skeletal muscle mass.
|
Baseline and 6 months
|
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Anthropometric circumferences
Zeitfenster: Baseline and 6 months
|
Changes in upper-limb, lower-limb, and trunk circumferences measured using standardized anthropometric procedures.
|
Baseline and 6 months
|
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Health-related quality of life
Zeitfenster: 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.
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Baseline to 6 months
|
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Medication burden
Zeitfenster: Baseline to 6 months
|
Changes in the number of prescribed medications and antihypertensive drugs between baseline and follow-up.
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Baseline to 6 months
|
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Dialysis adequacy
Zeitfenster: Baseline to 6 months
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Changes in dialysis adequacy expressed as Kt/V.
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Baseline to 6 months
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Dialysis session duration
Zeitfenster: Baseline and 6 months
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Changes in the duration of the hemodialysis session (min).
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Baseline and 6 months
|
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Blood flow rate
Zeitfenster: Baseline and 6 months
|
Changes in blood flow rate (Qb) during hemodialysis.
|
Baseline and 6 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Juni 2024
Primärer Abschluss (Tatsächlich)
1. Oktober 2025
Studienabschluss (Geschätzt)
1. März 2027
Studienanmeldedaten
Zuerst eingereicht
24. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. September 2026
Zuerst gepostet (Tatsächlich)
15. September 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
15. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
14. September 2026
Zuletzt verifiziert
1. September 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 0079556CE
- CUP E63C22002050006 (Andere Zuschuss-/Finanzierungsnummer: National Recovery and Resilience Plan (PNRR), Age-It - Spoke 4)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
UNENTSCHIEDEN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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