Physical Exercise in Patients With Chronic Kidney Disease in Hemodialysis (Pehedal-ESKD) (Pehedal-ESKD)
14 september 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Studietyp
Interventionell
Inskrivning (Beräknad)
312
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Ersilia Satta, PhD MD
- Telefonnummer: +39 3395703091
- E-post: e.satta@consorzionefrocenter.it
Studieorter
-
-
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Torre del Greco, Italien, 80059
- Rekrytering
- NefroCenter Dialysis Centers
-
Kontakt:
- Study Coordinator, PhD
- Telefonnummer: +39 3395703091
- E-post: e.satta@consorzionefrocenter.it
-
Huvudutredare:
- Ersilia Satta, PhD MD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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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.
|
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.
|
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.
|
|
Inget ingripande: 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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Incidence of intradialytic intolerance and hemodynamic instability
Tidsram: Baseline to 6 months
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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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Maximal workload during cycle ergometer stress testing
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline and 6 months
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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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline to 6 months
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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
Tidsram: Baseline and 6 months
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Changes in bone mineral content assessed by radiofrequency echographic multi-spectrometry (REMS).
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Baseline and 6 months
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Bone mineral status (T-score)
Tidsram: Baseline and 6 months
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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)
Tidsram: Baseline and 6 months
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Changes in appendicular skeletal muscle mass index (ASMMI) as a measure of skeletal muscle mass.
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Baseline and 6 months
|
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Anthropometric circumferences
Tidsram: Baseline and 6 months
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Changes in upper-limb, lower-limb, and trunk circumferences measured using standardized anthropometric procedures.
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Baseline and 6 months
|
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Health-related quality of life
Tidsram: 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
Tidsram: Baseline to 6 months
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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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline and 6 months
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Changes in blood flow rate (Qb) during hemodialysis.
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Baseline and 6 months
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Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juni 2024
Primärt slutförande (Faktisk)
1 oktober 2025
Avslutad studie (Beräknad)
1 mars 2027
Studieregistreringsdatum
Först inskickad
24 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
14 september 2026
Första postat (Faktisk)
15 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 0079556CE
- CUP E63C22002050006 (Annat bidrag/finansieringsnummer: National Recovery and Resilience Plan (PNRR), Age-It - Spoke 4)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
IPD-planbeskrivning
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.
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