Physical Exercise in Hemodialysis Patients in End Stage Kidney Disease
| Registry | NCT07820514, acronym Pehedal-ESKD |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 312 (Estimated) |
| Sponsor | Ricerca Nefrocenter (Other); collaborators: University of Naples, Federico II University |
| Conditions | Chronic Kidney Disease on Hemodialysis, Physical Exercise Behavior (Liking/Aversion) |
| Interventions | Intradialytic aerobic exercise using a cycle ergometer, Intradialytic elastic-band resistance exercise (Behavioral) |
| Dates | start 2024-06-01, primary completion 2025-10-01, completion 2027-03-01 (estimated), first posted 2026-09-15, last updated 2026-09-15 |
| Locations | 1 site in Italy |
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All trials for Chronic Kidney Disease on Hemodialysis All trials for Physical Exercise Behavior (Liking/Aversion) All trials of Intradialytic aerobic exercise using a cycle ergometer All trials of Intradialytic elastic-band resistance exercise
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cycle ergometer | Active comparator | Behavioral: 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 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. |
| Elastic band resistance training | Active comparator | Behavioral: 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 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. |
| Control | No intervention | 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. |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| NefroCenter Dialysis Centers | Torre del Greco | Italy | Recruiting |