Benefits of a Renal Rehabilitation Program Adapted to Uremic Patients on Daily Hemodialysis at Low Dialysate Flow Rate.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Brugmann University Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Hand grip test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Hemodialysis patients
Patients under hemodialysis
Intervention: Low flow rate hemodialysis (Procedure)
Hemodialysis patients
Patients under hemodialysis
Intervention: Multidisciplinary rehabilitation program (Other)
Outcomes
Primary Outcomes
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
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
- Kt/V(At discharge from the rehabilitation ward, in general up to 24 weeks after admission)
- Myostatin blood levels(At admission in the rehabilitation ward)
- Myostatin blood levels(At discharge from the rehabilitation ward, in general up to 24 weeks after admission)
- Activin A blood levels(At admission in the rehabilitation ward)
- Activin A blood levels(At discharge from the rehabilitation ward, in general up to 24 weeks after admission)
- IGF1 blood levels(At admission in the rehabilitation ward)
- IGF1 blood levels(At discharge from the rehabilitation ward, in general up to 24 weeks after admission)
- Kt/V(At admission in the rehabilitation ward)
- 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)
- Muscle ultrasound conclusion(At discharge from the rehabilitation ward, in general up to 24 weeks after admission)
- SF-36(At admission in the rehabilitation ward)
- SF-36(At discharge from the rehabilitation ward, in general up to 24 weeks after admission)
Investigators
Tatiana Besse-Hammer
Head of clinical trial unit
Brugmann University Hospital