An interventional study of Low flow rate hemodialysis and Multidisciplinary rehabilitation program in Chronic Kidney Disease Requiring Hemodialysis, Sarcopenia and Rehabilitation Program, sponsored by Brugmann University Hospital. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Brugmann University Hospital · Not applicable, Interventional, and Treatment
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:
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 855 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Brugmann University Hospital is the lead sponsor of 117 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients under hemodialysis
Procedure: Low flow rate hemodialysis · Other: Multidisciplinary rehabilitation program
Low flow rate hemodialysis five times per week
Tailor made rehabilitation program
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
Time frame: 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
Time frame: At discharge from the rehabilitation ward, in general up to 24 weeks after admission
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: At admission in the rehabilitation ward
Kt/V
Blood test evaluating the quality of the dialysis on weekly basis
Time frame: At discharge from the rehabilitation ward, in general up to 24 weeks after admission
Myostatin blood levels
Blood levels of Myostatin (sarcopenia biomarker)
Time frame: At admission in the rehabilitation ward
Myostatin blood levels
Blood levels of Myostatin (sarcopenia biomarker)
Time frame: 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)
Time frame: At admission in the rehabilitation ward
Activin A blood levels
Blood levels of Activin A (sarcopenia biomarker)
Time frame: At discharge from the rehabilitation ward, in general up to 24 weeks after admission
IGF1 blood levels
Blood levels of IGF1 (biomarker)
Time frame: At admission in the rehabilitation ward
IGF1 blood levels
Blood levels of IGF1 (biomarker)
Time frame: At discharge from the rehabilitation ward, in general up to 24 weeks after admission
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Dec 2027, 40 months after the start.
Of 492 non-industry interventional studies with no phase under Sarcopenia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's planned 40 months is above that.
Counting every sponsor, half of 503 studies reached it within 18 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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