Physical Exercise in Patients With Chronic Kidney Disease in Hemodialysis (Pehedal-ESKD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRicerca Nefrocenter
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Receiving maintenance hemodialysis for more than 3 months.
Clinically stable condition.
Ability and willingness to provide written informed consent.
Disqualifiers
Unstable angina.
Uncontrolled hypertension.
Any medical condition judged by the treating nephrologist to contraindicate or make intradialytic exercise unsafe
Trial design
Design model
Parallel
Treatments tested in this trial
Intradialytic aerobic exercise using a cycle ergometer
BehavioralParticipants 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.
Intradialytic elastic-band resistance exercise
BehavioralParticipants 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.
Treatment groups
312 Participants
are divided into 3 treatment groupsGroup A: Cycle ergometerActive comparator 1 intervention
Group B: Elastic band resistance trainingActive comparator 1 intervention
Group C: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Incidence of intradialytic intolerance and hemodynamic instability
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.
Time frame
Baseline to 6 monthsSecondary outcomes
1
Maximal workload during cycle ergometer stress testing
Changes in maximal workload achieved during cycle ergometer stress testing.
Time frame
Baseline to 6 months2
Six-minute walk test distance
Changes in distance covered during the 6-minute walk test as a measure of functional exercise capacity.
Time frame
Baseline and 6 months3
Step-test performance
Changes in step-test performance as an indicator of functional mobility and lower-limb performance.
Time frame
Baseline and 6 months4
Chair-stand test performance
Changes in the number of repetitions completed during the chair-stand test as a measure of lower-limb muscle function.
Time frame
Baseline and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov