Intradialytic Exercise With Blood Flow Restriction in Hemodialysis Patients

NCT ID: NCT07269379

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-06
• Study Completion Date: 2028-10-06

Brief Summary

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.

Conditions

Dialysis Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Experimental: HD-EXChro

Will be enrolled in a 12 weeks intradialytic exercise program without vascular occlusion

Group Type: EXPERIMENTAL

Chronic phase - HDEX/HDBFRE

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Experimental: HD-BFREChro

Will be enrolled in a 12 weeks intradialytic exercise program with vascular occlusion

Group Type: EXPERIMENTAL

Chronic phase - HDEX/HDBFRE

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Control

Patients with standard HD (usual care)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Chronic phase - HDEX/HDBFRE

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

Intervention Type: OTHER

Acute phase - HDEX/HDBFRE

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

Intervention Type: OTHER

Eligibility 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.
• Patients stratified as high risk for deep venous thrombosis

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Médipôle Lyon-Villeurbanne

OTHER

Sponsor Role: collaborator

Nouvel Hôpital Civil, 1 place de l'Hôpital 67091 Strasbourg cedex

UNKNOWN

Sponsor Role: collaborator

University of Avignon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nans Florens, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Strasbourg

Locations

CHU Strasbourg

Strasbourg, , France

Site Status: NOT_YET_RECRUITING

Medipole Lyon

Villeurbanne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Philippe Obert, PhD

Role: CONTACT

philippe.obert@univ-avignon.fr

0033698050446

Facility Contacts

Nans Florens, PhD

Role: primary

nans.florens@chru-strasbourg.fr

0033681250605

Thomas Fournier, PhD

Role: primary

tfournier12@gmail.com

0033 6 81 15 80 50

Other Identifiers

LAPEC/2025/ERO-CARD

Identifier Type: OTHER

Identifier Source: secondary_id

AU-092025-CM

Identifier Type: -

Identifier Source: org_study_id