EX-CHRODIAL: Chronic Intradialytic Exercise : a Cardioprotective Role
Study Details
Study Description
Brief Summary
The main objective is to assess the effects of chronic intradialytic physical exercise on myocardial remodelling and regional function.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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). |
Outcome Measures
Primary Outcome Measures
- Changes in myocardial longitudinal deformations [Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.]
Myocardial longitudinal linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.
- Changes in myocardial longitudinal deformations [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).]
Myocardial longitudinal linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.
- Changes in myocardial circumferential deformations [Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.]
Myocardial circumferential linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.
- Changes in myocardial circumferential deformations [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).]
Myocardial circumferential linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.
- Changes in left ventricular torsion [Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.]
Left ventricular torsion (in degree) will be assessed by high-resolution echocardiography in deformation imaging mode.
- Changes in left ventricular torsion [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).]
Left ventricular torsion (in degree) will be assessed by high-resolution echocardiography in deformation imaging mode.
Secondary Outcome Measures
- Changes in arterial rigidity [before (week 0) and after (week 17) an exercise training program of 16 weeks]
Measurement of pulse wave velocity (m/s) by photo-plethysmography at rest before dialysis.
- Changes in Physical fitness [before (week 0) and after (week 17) an exercise training program of 16 weeks]
The six-minute walking test (meters); maximal isometric force (newtons) during a knee-extension test and handgrip test using a dynamometer.
- Health-related Quality of life [before (week 0) and after (week 17) an exercise training program of 16 weeks]
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.
- Changes in carotid intimal-media wall thickness [before (week 0) and after (week 17) an exercise training program of 16 weeks]
The intimal plus media wall thickness (mm) of the right carotid artery will be measured using high-resolution echography.
Eligibility Criteria
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:
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Pregnancy
-
Valvular heart disease,
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Unstable coronary artery disease
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Arteriopathy obliterating of the lower limbs stage III and IV
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Musculoskeletal problems
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Severe respiratory disease
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BMI> 35
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Pacemaker, cardiac stimulation and automatic implantable defibrillator
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Heart transplant
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Uncontrolled arterial hypertension
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Ejection fraction <45%
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hemodialyse AIDER sante | Nîmes | Gard | France | 30029 |
| 2 | ATIR | Avignon | Vaucluse | France | 84000 |
Sponsors and Collaborators
- University of Avignon
Investigators
- Study Chair: Philippe Obert, Pr., Avignon University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-09-14