Chronic Kidney Disease Requiring HemodialysisNCT07413315
Benefits of a Renal Rehabilitation Program Adapted to Uremic Patients on Daily Hemodialysis at Low Dialysate Flow Rate.
A study testing Low flow rate hemodialysis and Multidisciplinary rehabilitation program in people with Chronic Kidney Disease Requiring Hemodialysis and Sarcopenia, run by Brugmann University Hospital at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Requiring Hemodialysis, Sarcopenia, Rehabilitation Program
- What is being tested?
- Low flow rate hemodialysis and Multidisciplinary rehabilitation program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Aug 2024to 31 Dec 2027
- Phase
- Interventional
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
- patient with terminal chronic kidney disease requiring hemodialysis treatment
- patient recently hospitalized for an acute medical event.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CHU Brugmann
Brussels, 1020
Joris Vanparys, MD, +3227455264, Joris.VANPARYS@chu-brugmann.be
Joris Vanparys, MD
About this study
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.
Read more
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.
- Being tested
- Low flow rate hemodialysis, Multidisciplinary rehabilitation program
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low flow rate hemodialysisProcedure or surgery
Low flow rate hemodialysis five times per week
Multidisciplinary rehabilitation programOther
Tailor made rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis patients | Experimental | Patients under hemodialysis Receives: Procedure: Low flow rate hemodialysis; Other: Multidisciplinary rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At discharge from the rehabilitation ward, in general up to 24 weeks after admission
Secondary outcomes (16)
Short physical performance battery test (SPPB)
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.
Measured: At admission in the rehabilitation ward
Short physical performance battery test (SPPB)
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.
Measured: At discharge from the rehabilitation ward, in general up to 24 weeks after admission
Six minutes walking test (6 MWT)
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.
Measured: At admission in the rehabilitation ward
Six minutes walking test (6 MWT)
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.
Measured: At discharge from the rehabilitation ward, in general up to 24 weeks after admission
Muscle ultrasound conclusion
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.
Measured: At admission in the rehabilitation ward
Muscle ultrasound conclusion
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.
Measured: At discharge from the rehabilitation ward, in general up to 24 weeks after admission
SF-36
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.
Measured: At admission in the rehabilitation ward
SF-36
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.
Measured: At discharge from the rehabilitation ward, in general up to 24 weeks after admission
Kt/V
Blood test evaluating the quality of the dialysis on weekly basis
Measured: At admission in the rehabilitation ward
Kt/V
Blood test evaluating the quality of the dialysis on weekly basis
Measured: At discharge from the rehabilitation ward, in general up to 24 weeks after admission
Myostatin blood levels
Blood levels of Myostatin (sarcopenia biomarker)
Measured: At admission in the rehabilitation ward
Myostatin blood levels
Blood levels of Myostatin (sarcopenia biomarker)
Measured: At discharge from the rehabilitation ward, in general up to 24 weeks after admission
Activin A blood levels
Blood levels of Activin A (sarcopenia biomarker)
Measured: At admission in the rehabilitation ward
Activin A blood levels
Blood levels of Activin A (sarcopenia biomarker)
Measured: At discharge from the rehabilitation ward, in general up to 24 weeks after admission
IGF1 blood levels
Blood levels of IGF1 (biomarker)
Measured: At admission in the rehabilitation ward
IGF1 blood levels
Blood levels of IGF1 (biomarker)
Measured: At discharge from the rehabilitation ward, in general up to 24 weeks after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start13 Aug 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 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 Requiring 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatiana Besse-Hammer, Brugmann University Hospital
- Investigators
- Joris Vanparys, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413315
- Sponsor's protocol ID
- REVADIAL
- Status last verified
- Feb 2026
- First submitted
- 25 Nov 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No