Physical Exercise in Patients With Chronic Kidney Disease in Hemodialysis (Pehedal-ESKD)

NCT07820514 | Recruiting

• 2 other identifiers: 0079556CECUP E63C22002050006
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Kidney Disease on Hemodialysis; Physical Exercise Behavior (Liking/Aversion)

Keywords

hemodialysis; intradialytic exercise; aerobic training; resistance training; sarcopenia; quality of life

Outcome Measures

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.

  Baseline to 6 months

Secondary Outcomes (16)

• Maximal workload during cycle ergometer stress testing

  Baseline to 6 months

• Six-minute walk test distance

  Baseline and 6 months

• Step-test performance

  Baseline and 6 months

• Chair-stand test performance

  Baseline and 6 months

• Handgrip strength

  Baseline and 6 months

Study Arms (3)

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.

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.

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.

Interventions

Intradialytic aerobic exercise using a cycle ergometer BEHAVIORAL

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.

Cycle ergometer

Intradialytic elastic-band resistance exercise BEHAVIORAL

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.

Elastic band resistance training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Receiving maintenance hemodialysis for more than 3 months.
• Clinically stable condition.
• Ability and willingness to provide written informed consent.

You may not qualify if:

• Unstable angina.
• Uncontrolled hypertension.
• Any medical condition judged by the treating nephrologist to contraindicate or make intradialytic exercise unsafe

Sponsors & Collaborators

• Ricerca Nefrocenter: lead
• University of Naples: collaborator
• Federico II University: collaborator

Study Sites (1)

NefroCenter Dialysis Centers

Torre del Greco, 80059, Italy

RECRUITING

Related Links

• Official study webpage providing information on the study rationale, objectives, design, interventions, and participating dialysis centers

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Ersilia Satta, PhD MD

CONTACT

+39 3395703091; e.satta@consorzionefrocenter.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 15, 2026
• Study Start: June 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

IT (1)