Clinical trial NCT04697459: Chronic Intradialytic Exercise : a Cardioprotective Role
Official title: Chronic Intradialytic Exercise: a Cardioprotective Role
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Failure
Keywords: exercise
hemodialysis
Lead sponsor: University of Avignon
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Acute phase : standard HD versus HD with acute intradialytic exercise (in HD-EX group only);
* Chronic phase : before and after an exercise training program of 16 weeks (HD-EX group) as well as before and after 16 weeks of standard HD (HD group)
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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%

Primary outcomes:
measure: Changes in myocardial longitudinal deformations
timeFrame: Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.
measure: Changes in myocardial longitudinal deformations
timeFrame: 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).
measure: Changes in myocardial circumferential deformations
timeFrame: Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.
measure: Changes in myocardial circumferential deformations
timeFrame: 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).
measure: Changes in left ventricular torsion
timeFrame: Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.
measure: Changes in left ventricular torsion
timeFrame: 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 outcomes:
measure: Changes in arterial rigidity
timeFrame: before (week 0) and after (week 17) an exercise training program of 16 weeks
measure: Changes in Physical fitness
timeFrame: before (week 0) and after (week 17) an exercise training program of 16 weeks
measure: Health-related Quality of life
timeFrame: before (week 0) and after (week 17) an exercise training program of 16 weeks
measure: Changes in carotid intimal-media wall thickness
timeFrame: before (week 0) and after (week 17) an exercise training program of 16 weeks
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre Hemodialyse AIDER sante
state: Gard
city: Avignon
country: France
facility: ATIR
state: Vaucluse
Study officials:
affiliation: Avignon University
name: Philippe Obert, Pr.
role: STUDY_CHAIR
References: