Intradialytic Exercise and Remote Ischaemic Preconditioning: a Cardioprotective Role ? (EXPI-DIAL)

University of Avignon

Status: Enrolling

Conditions: Hemodialysis

Treatments: Other: Remote ischaemic preconditioning; Other: standard dialysis; Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06856512

AU-092024-CM

LAPEC/2024/DIAL (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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 Criteria

• 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

46 participants in 1 patient group

Patients issued from dialysis units (clinic)

Experimental group

Description:

Randomised, controlled, crossover, bicentric, single-blind, prospective, open-label, superiority clinical trial comparing 3 dialysis modalities: Procedure A: Standard dialysis Procedure B: Dialysis with intradialytic intermittent physical exercise Procedure C: Dialysis with intradialytic ischaemia/reperfusion sequence of the upper limb Each subject will realize the 3 sessions in a random order.

Treatment:

Other: Exercise

Other: standard dialysis

Other: Remote ischaemic preconditioning