Chronic Intradialytic Exercise : a Cardioprotective Role (EX-CHRODIAL)
Primary Purpose
Chronic Renal Failure
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
chronic phase
acute phase
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Renal Failure focused on measuring exercise, hemodialysis
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%
Sites / Locations
- Centre Hemodialyse AIDER santeRecruiting
- ATIRRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
HD-EX (patient with intradialytic exercise)
HD (patients with standard HD)
Arm Description
will be enrolled in a 16 week intradilatytic exercise program.
patients with standard hemodialysis (e.g. without exercise).
Outcomes
Primary Outcome Measures
Changes in myocardial longitudinal deformations
Myocardial longitudinal linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.
Changes in myocardial longitudinal deformations
Myocardial longitudinal linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.
Changes in myocardial circumferential deformations
Myocardial circumferential linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.
Changes in myocardial circumferential deformations
Myocardial circumferential linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.
Changes in left ventricular torsion
Left ventricular torsion (in degree) will be assessed by high-resolution echocardiography in deformation imaging mode.
Changes in left ventricular torsion
Left ventricular torsion (in degree) will be assessed by high-resolution echocardiography in deformation imaging mode.
Secondary Outcome Measures
Changes in arterial rigidity
Measurement of pulse wave velocity (m/s) by photo-plethysmography at rest before dialysis.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04697459
Brief Title
Chronic Intradialytic Exercise : a Cardioprotective Role
Acronym
EX-CHRODIAL
Official Title
Chronic Intradialytic Exercise: a Cardioprotective Role
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2020 (Actual)
Primary Completion Date
May 14, 2023 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Avignon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure
Keywords
exercise, hemodialysis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
Investigator
Allocation
Non-Randomized
Enrollment
61 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HD-EX (patient with intradialytic exercise)
Arm Type
Experimental
Arm Description
will be enrolled in a 16 week intradilatytic exercise program.
Arm Title
HD (patients with standard HD)
Arm Type
No Intervention
Arm Description
patients with standard hemodialysis (e.g. without exercise).
Intervention Type
Other
Intervention Name(s)
chronic phase
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
acute phase
Intervention Description
30 min of low-intensity (Borg Scale 11-14) aerobic exercise, starting 30 min after hemodialysis beginning
Primary Outcome Measure Information:
Title
Changes in myocardial longitudinal deformations
Description
Myocardial longitudinal linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.
Time Frame
Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.
Title
Changes in myocardial longitudinal deformations
Description
Myocardial longitudinal linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.
Time Frame
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).
Title
Changes in myocardial circumferential deformations
Description
Myocardial circumferential linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.
Time Frame
Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.
Title
Changes in myocardial circumferential deformations
Description
Myocardial circumferential linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.
Time Frame
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).
Title
Changes in left ventricular torsion
Description
Left ventricular torsion (in degree) will be assessed by high-resolution echocardiography in deformation imaging mode.
Time Frame
Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.
Title
Changes in left ventricular torsion
Description
Left ventricular torsion (in degree) will be assessed by high-resolution echocardiography in deformation imaging mode.
Time Frame
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 Measure Information:
Title
Changes in arterial rigidity
Description
Measurement of pulse wave velocity (m/s) by photo-plethysmography at rest before dialysis.
Time Frame
before (week 0) and after (week 17) an exercise training program of 16 weeks
Title
Changes in Physical fitness
Description
The six-minute walking test (meters); maximal isometric force (newtons) during a knee-extension test and handgrip test using a dynamometer.
Time Frame
before (week 0) and after (week 17) an exercise training program of 16 weeks
Title
Health-related Quality of life
Description
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.
Time Frame
before (week 0) and after (week 17) an exercise training program of 16 weeks
Title
Changes in carotid intimal-media wall thickness
Description
The intimal plus media wall thickness (mm) of the right carotid artery will be measured using high-resolution echography.
Time Frame
before (week 0) and after (week 17) an exercise training program of 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe OBERT, Pr.
Phone
+33698050446
Email
philippe.obert@univ-avignon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Obert, Pr.
Organizational Affiliation
Avignon University
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hemodialyse AIDER sante
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure Patrier, Dr
Phone
+334 30 81 13 20
Email
l.patrier@aidersante.com
Facility Name
ATIR
City
Avignon
State/Province
Vaucluse
ZIP/Postal Code
84000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myriam Isnard, Dr.
Phone
+334 90 88 82 72
Email
myriam.isnard@orange.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Chronic Intradialytic Exercise : a Cardioprotective Role
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