Intradialytic Exercise and Remote Ischaemic Preconditioning: a Cardioprotective Role ?

NCT06856512 | Completed

• 2 other identifiers: AU-092024-CMLAPEC/2024/DIAL
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hemodialysis

Keywords

Hemodialysis; myocardial function; exercise; remote ischemic preconditioning; myocardial stunning; cardioprotection

Outcome Measures

Primary Outcomes (1)

• Change in regional myocardial stunning.

  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 changes in regional wall motion abnormalities across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.

  From enrollment to the end of treatment at 7 weeks

Secondary Outcomes (91)

• Hemorheology - blood viscosity

  From enrollment to the end of treatment at 7 weeks

• Hemorheology - erythrocyte deformability

  From enrollment to the end of treatment at 7 weeks

• Hemorheology - erythrocyte aggregation

  From enrollment to the end of treatment at 7 weeks

• Biological data - fibrinogen

  From enrollment to the end of treatment at 7 weeks

• Biological data - miRNA

  From enrollment to the end of treatment at 7 weeks

Study Arms (1)

Patients issued from dialysis units (clinic)

EXPERIMENTAL

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.

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

Interventions

Remote ischaemic preconditioning OTHER

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).

Patients issued from dialysis units (clinic)

Exercise OTHER

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).

Patients issued from dialysis units (clinic)

standard dialysis OTHER

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.

Patients issued from dialysis units (clinic)

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Avignon: lead

Study Sites (3)

Aider Sante

Montpellier, France

Location

Aider Sante

Nîmes, France

Location

CHU Strasbourg

Strasbourg, France

Location

MeSH Terms

Conditions

Motor Activity; Myocardial Stunning

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Laure Patrier, MD, PhD

  AIDER Santé - Fondation Charles Mion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients are randomly assigned to standard dialysis, dialysis with intermittent intradialytic exercise and dialysis with intermittent remote ischaemic preconditioning.

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: March 4, 2025
• Study Start: February 17, 2025
• Primary Completion: June 26, 2025
• Study Completion: June 26, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)