Chronic Intradialytic Exercise : a Cardioprotective Role (EX-CHRODIAL)

Chronic Intradialytic Exercise: a Cardioprotective Role

The main objective is to assess the effects of chronic intradialytic physical exercise on myocardial remodelling and regional function.

Study Overview

• Status: Completed
• Conditions: Chronic Renal Failure
• Intervention / Treatment: Other: chronic phase; Other: acute phase

Detailed Description

Background: Hemodialysis patients have a mortality rate 50 times higher than in the general population, and the cause remains cardiovascular in more than half of the cases. A deleterious morphological and functional cardiac remodelling is well established in these patients, the causes of which are both the presence of factors specific to renal disease (hemodynamic and non-hemodynamic) and co-morbidities (diabetes, hypertension, etc. .) but also to the hemodialysis (HD) procedure itself, due to the sudden hemodynamic changes it imposes, leading to repeated episodes of intradialytic hypotension (HID) and myocardial stunning. The latter are now documented as direct contributors to the increased mortality observed in HD patients compared to the general population. The introduction of intradialytic physical exercise in the therapeutic program of HD patient is now recommended and practised routinely in many countries, in Scandinavia in particular. Several meta-analyses have clearly established its safety. The beneficial role of chronic intradialytic exercise in improving dialysis efficiency, mental health and quality of life, as well as the inflammatory status of HD patients is also clearly demonstrated. Chronic intradialytic exercise is also associated with improvements in overall fitness level, a parameter closely linked to cardiovascular mortality. Applied acutely during dialysis, it could play a cardioprotective role (e.g; limiting myocardial stunning), allowing haemodynamic and cardiac functional stabilization during HD. However, to our knowledge, no study to date has investigated the long-term effects of intradialytic exercise on remodelling and overall and regional heart function.

Aims: The main objective is to assess the effects of chronic intradialytic physical exercise on myocardial remodelling and regional function. The secondary objectives are to evaluate the effect of acute intradialytic exercise on myocardial stunning as well as the effect of chronic physical exercise on macro and microcirculatory vascular function, inflammation, physical fitness and health-related quality of life.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes, Gard, France, 30029
      • Centre Hemodialyse AIDER sante
  • Vaucluse
    • Avignon, Vaucluse, France, 84000
      • ATIR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• No medical contraindication to physical activity
• Life expectancy greater than 6 months
• Patients on haemodialysis for more than 3 months

Exclusion Criteria:

• Pregnancy

  • Valvular heart disease,
  • Unstable coronary artery disease
  • Arteriopathy obliterating of the lower limbs stage III and IV
  • Musculoskeletal problems
  • Severe respiratory disease
  • BMI> 35
  • Pacemaker, cardiac stimulation and automatic implantable defibrillator
  • Heart transplant
  • Uncontrolled arterial hypertension
  • Ejection fraction <45%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HD-EX (patient with intradialytic exercise); will be enrolled in a 16 week intradilatytic exercise program.	Other: chronic phase; 1h of intradialytic execise, starting 30 min after hemodialysis beginning : 30 min of low-intensity (Borg Scale 11-14) aerobic exercise + 30 min of resistance training, frequency : 3 times a week for 16 weeks.; Other: acute phase; 30 min of low-intensity (Borg Scale 11-14) aerobic exercise, starting 30 min after hemodialysis beginning
No Intervention: HD (patients with standard HD); patients with standard hemodialysis (e.g. without exercise).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in myocardial longitudinal deformations	Myocardial longitudinal linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.	Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.
Changes in myocardial longitudinal deformations	Myocardial longitudinal linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.	Chronic phase : before (week 0) and after (week 17) an exercise training program of 16 weeks; each time in the same conditions as in acute phase (e.g. just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise).
Changes in myocardial circumferential deformations	Myocardial circumferential linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.	Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.
Changes in myocardial circumferential deformations	Myocardial circumferential linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.	Chronic phase : before (week 0) and after (week 17) an exercise training program of 16 weeks; each time in the same conditions as in acute phase (e.g. just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise).
Changes in left ventricular torsion	Left ventricular torsion (in degree) will be assessed by high-resolution echocardiography in deformation imaging mode.	Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.
Changes in left ventricular torsion	Left ventricular torsion (in degree) will be assessed by high-resolution echocardiography in deformation imaging mode.	Chronic phase : before (week 0) and after (week 17) an exercise training program of 16 weeks; each time in the same conditions as in acute phase (e.g. just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in arterial rigidity	Measurement of pulse wave velocity (m/s) by photo-plethysmography at rest before dialysis.	before (week 0) and after (week 17) an exercise training program of 16 weeks
Changes in Physical fitness	The six-minute walking test (meters); maximal isometric force (newtons) during a knee-extension test and handgrip test using a dynamometer.	before (week 0) and after (week 17) an exercise training program of 16 weeks
Health-related Quality of life	The 36-Item Short Form Health Survey questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.	before (week 0) and after (week 17) an exercise training program of 16 weeks
Changes in carotid intimal-media wall thickness	The intimal plus media wall thickness (mm) of the right carotid artery will be measured using high-resolution echography.	before (week 0) and after (week 17) an exercise training program of 16 weeks

Collaborators and Investigators

• Sponsor: University of Avignon
• Investigators: Study Chair: Philippe Obert, Pr., Avignon University

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2020
• Primary Completion (Actual): May 14, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: exercise; hemodialysis
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 2020-09-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No