Chronic Kidney Disease on HemodialysisPehedal-ESKDNCT07820514
Physical Exercise in Patients With Chronic Kidney Disease in Hemodialysis (Pehedal-ESKD)
A study testing Intradialytic aerobic exercise using a cycle ergometer and Intradialytic elastic-band resistance exercise in people with Chronic Kidney Disease on Hemodialysis and Physical Exercise Behavior (Liking/Aversion), run by Ricerca Nefrocenter at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease on Hemodialysis, Physical Exercise Behavior (Liking/Aversion)
- What is being tested?
- Intradialytic aerobic exercise using a cycle ergometer and Intradialytic elastic-band resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Receiving maintenance hemodialysis for more than 3 months.
- Clinically stable condition.
- Ability and willingness to provide written informed consent.
Who cannot join
- Unstable angina.
- Uncontrolled hypertension.
- Any medical condition judged by the treating nephrologist to contraindicate or make intradialytic exercise unsafe
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
NefroCenter Dialysis Centers
Torre del Greco, 80059
Study Coordinator, PhD, +39 3395703091, e.satta@consorzionefrocenter.it
Ersilia Satta, PhD MD
About this study
Official title: 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?
Read more
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.
- Being tested
- Intradialytic aerobic exercise using a cycle ergometer, Intradialytic elastic-band resistance exercise
- Keywords
- hemodialysis, intradialytic exercise, aerobic training, resistance training, sarcopenia, quality of life
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradialytic aerobic exercise using a cycle ergometerBehavioural
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.
Intradialytic elastic-band resistance exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cycle ergometer | Active comparator | 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. Receives: Behavioral: Intradialytic aerobic exercise using a cycle ergometer |
| Elastic band resistance training | Active comparator | 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. Receives: Behavioral: Intradialytic elastic-band resistance exercise |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months
Secondary outcomes (16)
Maximal workload during cycle ergometer stress testing
Changes in maximal workload achieved during cycle ergometer stress testing.
Measured: Baseline to 6 months
Six-minute walk test distance
Changes in distance covered during the 6-minute walk test as a measure of functional exercise capacity.
Measured: Baseline and 6 months
Step-test performance
Changes in step-test performance as an indicator of functional mobility and lower-limb performance.
Measured: Baseline and 6 months
Chair-stand test performance
Changes in the number of repetitions completed during the chair-stand test as a measure of lower-limb muscle function.
Measured: Baseline and 6 months
Handgrip strength
Changes in handgrip strength measured using a hand dynamometer.
Measured: Baseline and 6 months
Weekly exercise time
Changes in the total amount of exercise completed per week during the intervention period.
Measured: Throughout the 6-month intervention period
Fat-free mass and fat mass
Changes in fat-free mass and fat mass assessed by bioelectrical impedance analysis, both reported as percentage of body weight.
Measured: Baseline to 6 months
Bone mineral content
Changes in bone mineral content assessed by radiofrequency echographic multi-spectrometry (REMS).
Measured: Baseline and 6 months
Bone mineral status (T-score)
Changes in T-score as an indicator of bone mineral status.
Measured: Baseline and 6 months
Appendicular skeletal muscle mass index (ASMMI)
Changes in appendicular skeletal muscle mass index (ASMMI) as a measure of skeletal muscle mass.
Measured: Baseline and 6 months
Anthropometric circumferences
Changes in upper-limb, lower-limb, and trunk circumferences measured using standardized anthropometric procedures.
Measured: Baseline and 6 months
Health-related quality of life
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.
Measured: Baseline to 6 months
Medication burden
Changes in the number of prescribed medications and antihypertensive drugs between baseline and follow-up.
Measured: Baseline to 6 months
Dialysis adequacy
Changes in dialysis adequacy expressed as Kt/V.
Measured: Baseline to 6 months
Dialysis session duration
Changes in the duration of the hemodialysis session (min).
Measured: Baseline and 6 months
Blood flow rate
Changes in blood flow rate (Qb) during hemodialysis.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Jun 2024
- Primary completion1 Oct 2025
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease on HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ricerca Nefrocenter
- Sponsor type
- University, hospital or other
- Collaborators
- University of Naples, Federico II University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820514
- Sponsor's protocol ID
- 0079556CE
- Other IDs
- CUP E63C22002050006
- Acronym
- Pehedal-ESKD
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise in Hemodialysis Patients in End Stage Kidney Disease
- ClinicalTrials.gov ID
- NCT07820514
- Acronym / sponsor ID
- Pehedal-ESKD / 0079556CE
- Keywords
- hemodialysis, intradialytic exercise, aerobic training, resistance training, sarcopenia, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Ricerca NefrocenterUniversity, hospital or other
- Collaborators
- University of Naples, Federico II University
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cycle ergometer | Active comparator | Behavioral: Intradialytic aerobic exercise using a cycle ergometerParticipants 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 exerciseParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Receiving maintenance hemodialysis for more than 3 months.
- Clinically stable condition.
- Ability and willingness to provide written informed consent.
Key exclusion criteria (3 listed)
- Unstable angina.
- Uncontrolled hypertension.
- Any medical condition judged by the treating nephrologist to contraindicate or make intradialytic exercise unsafe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradialytic aerobic exercise using a cycle ergometerParticipants 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. | Behavioural | Cycle ergometer |
| Intradialytic elastic-band resistance exerciseParticipants 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. | Behavioural | Elastic band resistance training |
Primary outcome
Incidence of intradialytic intolerance and hemodynamic instability
Time frame: 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.
16 secondary outcomes
Maximal workload during cycle ergometer stress testing
Time frame: Baseline to 6 months
Six-minute walk test distance
Time frame: Baseline and 6 months
Step-test performance
Time frame: Baseline and 6 months
Chair-stand test performance
Time frame: Baseline and 6 months
Handgrip strength
Time frame: Baseline and 6 months
Weekly exercise time
Time frame: Throughout the 6-month intervention period
Fat-free mass and fat mass
Time frame: Baseline to 6 months
Bone mineral content
Time frame: Baseline and 6 months
Bone mineral status (T-score)
Time frame: Baseline and 6 months
Appendicular skeletal muscle mass index (ASMMI)
Time frame: Baseline and 6 months
Anthropometric circumferences
Time frame: Baseline and 6 months
Health-related quality of life
Time frame: Baseline to 6 months
Medication burden
Time frame: Baseline to 6 months
Dialysis adequacy
Time frame: Baseline to 6 months
Dialysis session duration
Time frame: Baseline and 6 months
Blood flow rate
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Official study webpage providing information on the study rationale, objectives, design, interventions, and participating dialysis centersLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradialytic aerobic exercise using a cycle ergometer and Intradialytic elastic-band resistance exercise in people with Chronic Kidney Disease on Hemodialysis and Physical Exercise Behavior (Liking/Aversion), run by Ricerca Nefrocenter at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ersilia Satta, PhD MD (+39 3395703091, e.satta@consorzionefrocenter.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intradialytic intolerance and hemodynamic instability (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.