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NCT Number: NCT07413315

Benefits of a Renal Rehabilitation Program Adapted to Uremic Patients on Daily Hemodialysis at Low Dialysate Flow Rate.

The concept of renal rehabilitation has become increasingly important with the increasing age of patients with severe or even terminal chronic kidney disease (CKD). It combines physical exercise and nutritional monitoring programs for patients with terminal CKD who are most often treated with conventional hemodialysis (HD) at a rate of 3 sessions of 4 hours per week.

Sarcopenia is a very common phenomenon in patients with CKD. The prevalence found in recent meta-analyses varies between 25.6 and 28.5% in patients treated with dialysis. It is even higher in patients treated with HD than in patients treated with peritoneal dialysis (PD). Younger and more active patients will more often choose PD. The conventional HD modality preserves residual renal function less well, which is important for better elimination of uremic toxins bound to plasma proteins. Conventional HD requires a higher immobilization time and causes more post-dialysis symptoms, leaving less time for the patient to be physically active.

The phenomenon of sarcopenia is not insignificant. It is associated in dialysis patients with a higher mortality rate (risk x 1.8) and a higher incidence of cardiovascular events (risk x 3.8). The association with higher mortality is well demonstrated for the 2 main components of sarcopenia, namely reduced muscle mass and reduced muscle strength. Sarcopenia also increases the risk of falls and fractures, it decreases the physical performance of patients and their ability to perform activities of daily living. The quality of life of patients is reduced and the probability of social placement is high.

The phenomena of sarcopenia and physical deconditioning are even more problematic in patients in HD after an acute medical problem. The need for rehabilitation is even higher. "Classical" HD treatment can be a burden for these patients, leaving no room for integrating a complete rehabilitation program.

Daily low dialysate flow rate hemodialysis (LDF) is a type of hemodialysis in which patients benefit from more frequent but shorter and hemodynamically better tolerated HD sessions. This new technique potentially presents certain advantages over conventional HD, particularly at the cardiovascular level: better blood pressure control and better reduction of left ventricular hypertrophy. LDF also allows better control of hyperphosphatemia with a reduced need for phosphorus binders. Thanks to more frequent dialysis (5 to 6 sessions per week), inter-dialytic weight gain is often less significant, allowing less aggressive ultrafiltration, with better hemodynamic tolerance, and better post-dialysis recovery. In this perspective, this study aims to examine the interest of integrating HDQ dialysis into a renal rehabilitation program in patients with terminal CKD whose dialysis must continue after an acute event requiring hospitalization. The investigators want to study whether this technique allows the implementation of a more effective rehabilitation program, while maintaining the same dialysis efficiency as with the conventional HD technique. To the investigator's knowledge, no study concerning patients under HDQ has been conducted during their renal rehabilitation phase.

The objectives of the current study are:

* To study the interest of integrating HDQ dialysis into a renal rehabilitation program in patients with terminal CKD. * To study the efficacy and tolerance of HDQ dialysis and the rehabilitation program in these patients.

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Key information

Conditions

Chronic Kidney Disease Requiring Hemodialysis Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rehabilitation Program Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Location status: Recruiting

Location contact

Joris Vanparys, MD

CONTACT

[email protected]

+3227455264

Joris Vanparys, MD

PRINCIPAL_INVESTIGATOR

Laura Leahu, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patient with terminal chronic kidney disease requiring hemodialysis treatment
  • patient recently hospitalized for an acute medical event.

Exclusion criteria

  • dementia/mild cognitive impairment (MMSE < 20/30)
  • decompensated psychiatric pathology and/or behavioral disorders
  • pregnant woman
  • recovery of renal function allowing interruption of helodialysis sessions
  • candidate for neurological rehabilitation
  • patient with recent spinal cord injury
  • patient with absolute and/or relative contraindication to performing a stress test
  • severe or poorly tolerated cardiac rhythm disorder
  • severe or symptomatic obstruction to left ventricular ejection
  • decompensated heart failure
  • acute myocarditis, pericarditis or endocarditis
  • acute aortic dissection
  • high-risk emboligenic intracardiac thrombus
  • significant stenosis of the common trunk
  • ventricular aneurysm
  • supraventricular tachycardia with poorly controlled ventricular rate, acquired high-degree or complete block
  • obstructive cardiomyopathy with high resting gradient
  • recent stroke or TIA
  • acute venous thrombosis with or without pulmonary embolism
  • poorly controlled clinical condition, such as marked anemia, significant electrolyte disturbance, hyperthyroidism, etc.
  • lack of cooperation from the patient
  • Blood pressure > 200/110 mmHg

Treatment and study plan

Low flow rate hemodialysis

Procedure

Low flow rate hemodialysis five times per week

Multidisciplinary rehabilitation program

Other

Tailor made rehabilitation program

Primary outcomes

  1. Hand grip test

    Time frame: At admission in the rehabilitation ward

    Grip strength (measured by means of a dynamometer) is recommended as a good simple measure of muscle strength. Low grip strength is a powerful predictor of poor patient outcomes such as longer hospital stays, increased functional limitations, poor health-related quality of life and death.

    Cut-off points for men <27 kg Cut-off points for women <16 kg

  2. Hand grip test

    Time frame: At discharge from the rehabilitation ward, in general up to 24 weeks after admission

    Grip strength (measured by means of a dynamometer) is recommended as a good simple measure of muscle strength. Low grip strength is a powerful predictor of poor patient outcomes such as longer hospital stays, increased functional limitations, poor health-related quality of life and death.

    Cut-off points for men <27 kg Cut-off points for women <16 kg

Secondary outcomes

  1. Short physical performance battery test (SPPB)

    Time frame: At admission in the rehabilitation ward

    The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability. The scores range from 0 (worst performance) to 12 (best performance). The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability. The maximum score is 12 points, and a score of ≤ 8 points indicates poor physical performance.

  2. Short physical performance battery test (SPPB)

    Time frame: At discharge from the rehabilitation ward, in general up to 24 weeks after admission

    The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability. The scores range from 0 (worst performance) to 12 (best performance). The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability. The maximum score is 12 points, and a score of ≤ 8 points indicates poor physical performance.

  3. Six minutes walking test (6 MWT)

    Time frame: At admission in the rehabilitation ward

    The 6-minute walk test (6MWT) is a commonly used test to assess functional exercise capacity. It evaluates the functional capacity of the individual and it provides information over the pulmonary and cardiovascular systems, blood circulation, neuromuscular system, body metabolism, and peripheral circulation. An increase in the distance walked indicates improvement in basic mobility. In the geriatric population: Small meaningful change 20 m, Substantial meaningful change 50 m.

  4. Six minutes walking test (6 MWT)

    Time frame: At discharge from the rehabilitation ward, in general up to 24 weeks after admission

    The 6-minute walk test (6MWT) is a commonly used test to assess functional exercise capacity. It evaluates the functional capacity of the individual and it provides information over the pulmonary and cardiovascular systems, blood circulation, neuromuscular system, body metabolism, and peripheral circulation. An increase in the distance walked indicates improvement in basic mobility. In the geriatric population: Small meaningful change 20 m, Substantial meaningful change 50 m.

  5. Muscle ultrasound conclusion

    Time frame: At admission in the rehabilitation ward

    Assessment of pennate muscles such as the quadriceps femoris can detect a decrease in muscle thickness and cross-sectional area within a relatively short period of time, the use of ultrasound has been expanded in clinical practice to support the diagnosis of sarcopenia in older adults.

  6. Muscle ultrasound conclusion

    Time frame: At discharge from the rehabilitation ward, in general up to 24 weeks after admission

    Assessment of pennate muscles such as the quadriceps femoris can detect a decrease in muscle thickness and cross-sectional area within a relatively short period of time, the use of ultrasound has been expanded in clinical practice to support the diagnosis of sarcopenia in older adults.

  7. SF-36

    Time frame: At admission in the rehabilitation ward

    Short Form Health Survey (SF-36) Standardised questionnaire measuring quality of life, reporting a physical componant summary score and a mental componant summary score, both ranging from 0 to 100, with lower scores indicating more disability and higher scores indicating less disability.

  8. SF-36

    Time frame: At discharge from the rehabilitation ward, in general up to 24 weeks after admission

    Short Form Health Survey (SF-36) Standardised questionnaire measuring quality of life, reporting a physical componant summary score and a mental componant summary score, both ranging from 0 to 100, with lower scores indicating more disability and higher scores indicating less disability.

  9. Kt/V

    Time frame: At admission in the rehabilitation ward

    Blood test evaluating the quality of the dialysis on weekly basis

  10. Kt/V

    Time frame: At discharge from the rehabilitation ward, in general up to 24 weeks after admission

    Blood test evaluating the quality of the dialysis on weekly basis

  11. Myostatin blood levels

    Time frame: At admission in the rehabilitation ward

    Blood levels of Myostatin (sarcopenia biomarker)

  12. Myostatin blood levels

    Time frame: At discharge from the rehabilitation ward, in general up to 24 weeks after admission

    Blood levels of Myostatin (sarcopenia biomarker)

  13. Activin A blood levels

    Time frame: At admission in the rehabilitation ward

    Blood levels of Activin A (sarcopenia biomarker)

  14. Activin A blood levels

    Time frame: At discharge from the rehabilitation ward, in general up to 24 weeks after admission

    Blood levels of Activin A (sarcopenia biomarker)

  15. IGF1 blood levels

    Time frame: At admission in the rehabilitation ward

    Blood levels of IGF1 (biomarker)

  16. IGF1 blood levels

    Time frame: At discharge from the rehabilitation ward, in general up to 24 weeks after admission

    Blood levels of IGF1 (biomarker)

Study contacts

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

Joris Vanparys, MD

CONTACT

[email protected]

+32 2475 52 64

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

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

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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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