Intradialytic Exercise With Blood Flow Restriction in Hemodialysis Patients

NCT07269379 | Recruiting

• 2 other identifiers: AU-092025-CMLAPEC/2025/ERO-CARD
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

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. 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. 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).

Conditions

Dialysis Patients

Keywords

end stage renal disease; hemodialysis; blood flow restriction exercise; intradialytic exercise; regional myocardial function; hemorheology

Outcome Measures

Primary Outcomes (1)

• 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)

  From enrollment to the end of the program at 19 weeks

Secondary Outcomes (80)

• Change in LV longitudinal strains

  From enrollment to the end of the program at 19 weeks

• Change in RV longitudinal strains

  From enrollment to the end of the program at 19 weeks

• Change in LA longitudinal strains

  From enrollment to the end of the program at 19 weeks

• Change in global constructive work

  From enrollment to the end of the program at 19 weeks

• Change in global wasted work

  From enrollment to the end of the program at 19 weeks

Study Arms (3)

Experimental: HD-EXChro

EXPERIMENTAL

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

Other: Chronic phase - HDEX/HDBFRE; Other: Acute phase - HDEX/HDBFRE

Experimental: HD-BFREChro

EXPERIMENTAL

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

Other: Chronic phase - HDEX/HDBFRE; Other: Acute phase - HDEX/HDBFRE

Control

NO INTERVENTION

Patients with standard HD (usual care)

Interventions

Chronic phase - HDEX/HDBFRE 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

Experimental: HD-BFREChro; Experimental: HD-EXChro

Acute phase - HDEX/HDBFRE 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; Experimental: HD-EXChro

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.
• Patients stratified as high risk for deep venous thrombosis

Sponsors & Collaborators

• University of Avignon: lead
• Médipôle Lyon-Villeurbanne: collaborator
• Nouvel Hôpital Civil, 1 place de l'Hôpital 67091 Strasbourg cedex: collaborator

Study Sites (2)

CHU Strasbourg

Strasbourg, France

NOT YET RECRUITING

Medipole Lyon

Villeurbanne, 69100, France

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nans Florens, PhD

  CHU Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Obert, PhD

CONTACT

0033698050446; philippe.obert@univ-avignon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Acute phase: 3 sessions per patient, realized in a random order : * standard HD (HD-CONTacute) * HD with acute intradialytic exercise without vascular occlusion (HD-EXacute) * HD with acute intradialytic exercise with vascular occlusion (HD-BFREacute). 2. Chronic phase: patients randomly assigned to one of the following 3 groups (ration 1:1:1): an exercise training program without (HD-EXChro) or with (HD-BFREChro) vascular occlusion, standard HD (HD-CONTChro) without exercise. Patients will be evaluated before and after 12 weeks of exercise rehabilitation (HD-EXChro, HD-BFREChro) or standard dialysis (HD-CONTChro).

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 8, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): May 6, 2028
• Study Completion (Estimated): October 6, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)