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NCT Number: NCT07820514

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

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.

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Key information

Conditions

Chronic Kidney Disease on Hemodialysis Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Physical Exercise Behavior (Liking/Aversion) Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NefroCenter Dialysis Centers

Torre del Greco, 80059, Italy

Location status: Recruiting

Location contact

Ersilia Satta, PhD MD

PRINCIPAL_INVESTIGATOR

Study Coordinator, PhD

CONTACT

[email protected]

+39 3395703091

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Maximal workload during cycle ergometer stress testing

    Time frame: Baseline to 6 months

    Changes in maximal workload achieved during cycle ergometer stress testing.

  2. Six-minute walk test distance

    Time frame: Baseline and 6 months

    Changes in distance covered during the 6-minute walk test as a measure of functional exercise capacity.

  3. Step-test performance

    Time frame: Baseline and 6 months

    Changes in step-test performance as an indicator of functional mobility and lower-limb performance.

  4. Chair-stand test performance

    Time frame: Baseline and 6 months

    Changes in the number of repetitions completed during the chair-stand test as a measure of lower-limb muscle function.

  5. Handgrip strength

    Time frame: Baseline and 6 months

    Changes in handgrip strength measured using a hand dynamometer.

  6. Weekly exercise time

    Time frame: Throughout the 6-month intervention period

    Changes in the total amount of exercise completed per week during the intervention period.

  7. Fat-free mass and fat mass

    Time frame: Baseline to 6 months

    Changes in fat-free mass and fat mass assessed by bioelectrical impedance analysis, both reported as percentage of body weight.

  8. Bone mineral content

    Time frame: Baseline and 6 months

    Changes in bone mineral content assessed by radiofrequency echographic multi-spectrometry (REMS).

  9. Bone mineral status (T-score)

    Time frame: Baseline and 6 months

    Changes in T-score as an indicator of bone mineral status.

  10. Appendicular skeletal muscle mass index (ASMMI)

    Time frame: Baseline and 6 months

    Changes in appendicular skeletal muscle mass index (ASMMI) as a measure of skeletal muscle mass.

  11. Anthropometric circumferences

    Time frame: Baseline and 6 months

    Changes in upper-limb, lower-limb, and trunk circumferences measured using standardized anthropometric procedures.

  12. Health-related quality of life

    Time frame: 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.

  13. Medication burden

    Time frame: Baseline to 6 months

    Changes in the number of prescribed medications and antihypertensive drugs between baseline and follow-up.

  14. Dialysis adequacy

    Time frame: Baseline to 6 months

    Changes in dialysis adequacy expressed as Kt/V.

  15. Dialysis session duration

    Time frame: Baseline and 6 months

    Changes in the duration of the hemodialysis session (min).

  16. Blood flow rate

    Time frame: Baseline and 6 months

    Changes in blood flow rate (Qb) during hemodialysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Ersilia Satta, PhD MD

CONTACT

[email protected]

+39 3395703091

Sponsors and collaborators

Lead sponsor

Ricerca Nefrocenter

Other

Collaborators

  • Federico II University
  • University of Naples

Registry information

Official study title

Physical Exercise in Hemodialysis Patients in End Stage Kidney Disease

Acronym: Pehedal-ESKD

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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