Intradialytic Exercise With Blood Flow Restriction in Hemodialysis Patients

ConditionDialysis Patients

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20-79

SponsorUniversity of Avignon

About this trial

The main objective is to evaluate in hemodialysis patients the effects of two intradialytic rehabilitation programs based on physical exercise, with or without the application of blood flow restriction, on myocardial stunning and morpho-functional cardiac remodelling, compared with usual care (i.e., dialysis without exercise). In addition, the investigators will also assess the acute effects (i.e., a single session for each condition) of physical exercise, with or without blood flow restriction, on myocardial stunning at the end of dialysis.

In comparison with a conventional exercise program, the combination of physical exercise with blood flow restriction, which synergistically and additively activates intramuscular signalling pathways related to both exercise and ischaemia, is hypothesised to result in:

1. A greater intradialytic cardioprotection, as demonstrated by a greater reduction in myocardial stunning at the end of dialysis (both in acute and chronic applications), with underlying mechanisms involving systemic and neuro-humoral pathways; 2. Significant improvements in morpho-functional cardiac remodelling, attenuation of arrhythmic disturbances, and enhancement of aerobic capacity, muscle strength, and muscle mass-effects not observed with exercise alone without blood flow restriction, considering the low exercise intensity used in the current rehabilitation program (chronic application only).

This is a three-arm randomised clinical trial with parallel groups: standard hemodialysis (HD-CONTChro), a rehabilitation program with intradialytic exercise without vascular occlusion (HD-EXChro), and a rehabilitation program with intradialytic exercise with vascular occlusion (HD-BFREChro), with a 1:1:1 allocation ratio.

To investigate the acute effects of the interventions, all patients will undergo, in a randomized order, one session of each of the three dialysis modalities-standard hemodialysis (HD-CONTacute), hemodialysis with exercise without vascular restriction (HD-EXacute), and hemodialysis with exercise with vascular restriction (HD-BFREacute)-prior to initiation of the chronic phase of the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged between 20 and 79 years.

Patients on hemodialysis for more than 3 months.

No engagement in regular exercise outside of dialysis.

No prior exposure to intradialytic exercise within the past six months.

Disqualifiers

Patient is participating in another Category I interventional study, or has participated in another interventional study within the past 3 months

The patient is in an exclusion period determined by a previous study

The patient is under legal protection or under guardianship or curatorship It turns out to be impossible to give the patient informed information, or the patient refuses to sign the consent

Pregnant, parturient or breastfeeding patient

Trial design

Design model

Parallel

Treatments tested in this trial

Chronic phase - HDEX/HDBFRE
Other intervention
30 min of intradialytic cycling at a moderate intensity (12-14) , starting 30min after HD onset. 3 times a week for 12 weeks. No vascular occlusion for HDEXChro. Pressure at 50% of limb occlusion pressure on both legs for HDBFREChro
Acute phase - HDEX/HDBFRE
Other intervention
30 min of intradialytic cycling at a moderate intensity (12-14) , starting 30min after HD onset. No vascular occlusion for HDEXacute. Pressure at 50% of limb occlusion pressure on both legs for HDBFREacute

Treatment groups

108 Participants

are divided into 3 treatment groups

Group A: Experimental: HD-EXChroExperimental treatment 2 interventions

Group B: Experimental: HD-BFREChroExperimental treatment 2 interventions

Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

Change in the number of regional wall motion abnormalities (RWMAs)

The investigators will use echocardiography to assess the number of left ventricular myocardial segments (using a 18-segment model), that demonstrate a reduction in longitudinal deformation greater than 20% at peak stress during hemodialysis, relative to baseline measurements obtained at the start of the dialysis session. Their aim is to compare the change in regional wall motion abnormalities (RWMAs) at peak stress of dialysis (i.e. 30 min before its end), in a standard HD, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). For the acute phase, the investigators will compare the number of RWMAs measured 30min before the end of each HD session between the 3 conditions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

Time frame