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

NCT07413315 | Recruiting

• 1 other identifier: REVADIAL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia; Rehabilitation Program; Chronic Kidney Disease Requiring Hemodialysis

Outcome Measures

Primary Outcomes (2)

• Hand grip test

  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

  At admission in the rehabilitation ward

• Hand grip test

  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

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

Secondary Outcomes (16)

• Short physical performance battery test (SPPB)

  At admission in the rehabilitation ward

• Short physical performance battery test (SPPB)

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

• Six minutes walking test (6 MWT)

  At admission in the rehabilitation ward

• Six minutes walking test (6 MWT)

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

• Muscle ultrasound conclusion

  At admission in the rehabilitation ward

Study Arms (1)

Hemodialysis patients

EXPERIMENTAL

Patients under hemodialysis

Procedure: Low flow rate hemodialysis; Other: Multidisciplinary rehabilitation program

Interventions

Low flow rate hemodialysis PROCEDURE

Low flow rate hemodialysis five times per week

Hemodialysis patients

Multidisciplinary rehabilitation program OTHER

Tailor made rehabilitation program

Hemodialysis patients

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

RECRUITING

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

Study Officials

• Joris Vanparys, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joris Vanparys, MD

CONTACT

+32 2475 52 64; Joris.VANPARYS@chu-brugmann.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinical trial unit

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: February 17, 2026
• Study Start: August 13, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)