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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrugmann University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patient with terminal chronic kidney disease requiring hemodialysis treatment

patient recently hospitalized for an acute medical event.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Low flow rate hemodialysis

    Procedure/Surgery

    Low flow rate hemodialysis five times per week

  • Multidisciplinary rehabilitation program

    Other intervention

    Tailor made rehabilitation program

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Hemodialysis patientsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
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

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

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