RecruitingNot ApplicableNCT06856512

Intradialytic Exercise and Remote Ischaemic Preconditioning: a Cardioprotective Role ?

Sponsor

University of Avignon

Enrollment

46 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

Hemodialysis

Summary

The aim of this clinical trial is to evaluate whether intermittent exercise and remote ischaemic preconditioning (rIPC) during haemodialysis (HD) can provide cardioprotection in adult patients (aged 20-79 years) undergoing HD for at least 3 months. The main questions to be answered are Does intermittent exercise or rIPC reduce myocardial stunning during HD? Do these interventions have a beneficial effect on haemorheology, arrhythmias, systemic inflammation and HD efficiency? The investigators will compare three HD sessions: no intervention (HD-CONT), with moderate-intensity intermittent exercise (HD-EX), and with rIPC using cuff inflation (HD-rIPC) to see if HD6EX and HD-rIPC approaches offer enhanced cardioprotection. Participants will: Undergo three randomised HD sessions. Participate in 5 blocks of moderate-intensity exercise or rIPC during the HD sessions. Have cardiac function and biomarkers assessed before, during and after HD.

Eligibility

Min Age: 20 YearsMax Age: 79 Years

Inclusion Criteria7

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.
No medical contraindications to physical activity.
Life expectancy greater than 6 months.
Patients with relative good echogenicity

Exclusion Criteria12

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
Patients with unstable coronary artery disease.
Patients with peripheral artery disease (stage III or IV) in the lower limbs.
Patients with limb amputation.
Patients with musculoskeletal disorders impairing exercise.
Presence of a pacemaker, cardiac stimulation device, or implantable cardioverter defibrillator (ICD).
History of heart transplant.
Patients with uncontrolled hypertension.
Refractory anemia.

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Interventions

OTHERRemote ischaemic preconditioning

The dialysis protocol integrates a sequence of five ischaemia/reperfusion blocks applied to the upper limb. Each block consists of a 5-minute period of cuff inflation at a supra-systolic pressure individualized to each patient-20 mmHg above the limb occlusion pressure-followed by a 25-minute period of cuff deflation. This intervention begins 30 minutes after the start of dialysis and is referred to as hemodialysis remote ischaemic preconditioning (HD-rIPC).

OTHERExercise

The exercise protocol consists of five sequential bouts of physical activity, initiated 30 minutes after the start of dialysis. Each bout comprises a 5-minute cycling exercise at moderate intensity, corresponding to a Borg Scale rating of 12-14, followed by a 25-minute passive recovery phase. This structured intervention is referred to as hemodialysis exercise (HD-EX).

OTHERstandard dialysis

The hemodialysis control condition (HD-CONT) consists of standard hemodialysis treatment without the integration of any additional interventions, such as exercise or ischaemia/reperfusion protocols.